Conservative Versus Operative - First Time Patella Dislocations
Primary Purpose
Patella Dislocation
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
medial patellofemoral reconstruction
Non-operative group
Sponsored by
About this trial
This is an interventional treatment trial for Patella Dislocation
Eligibility Criteria
Inclusion Criteria:
- age 12 and older
- patients seen by the Columbia University Shoulder Elbow and Sports Medicine Service
- patients who experience a first-time patella dislocation
Exclusion Criteria:
- coexistent ligament injury or osteochondral fracture necessitating acute surgical intervention
- previous knee surgery
- knee instability prior to injury
- inability or unwillingness to adhere to study participate
- lost to follow up
Sites / Locations
- Columbia University Irving Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Operative Group
Non-operative group
Arm Description
This group will have surgical procedure called a medial patellofemoral reconstruction where the kneecap is anchored back into its correct position)
This group will have physical therapy for their knee dislocation by following a specific rehabilitation plan.
Outcomes
Primary Outcome Measures
Change in Kujala Questionnaire Score at 2 weeks
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 6 weeks
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 3 months
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 6 months
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 1 year
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 2 years
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 5 years
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 10 years
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time to first re-dislocation
Time to first re-dislocation following intervention, measured in weeks
Secondary Outcome Measures
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 weeks
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 weeks
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 3 months
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 months
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 1 year
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 years
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 5 years
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 10 years
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 weeks
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 weeks
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 3 Months
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 Months
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 1 Year
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 Years
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 5 Years
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 10 Years
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 weeks
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 weeks
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 3 months
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 months
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 1 year
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 years
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 5 years
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 10 years
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Percentage of participants who re-dislocate their knee after treatment at each time point within each group
Percentage of group that experienced re-dislocation after treatment starts at each time point
Time to return to full activity or sports for each group
Time from treatment initiation to full return to pre-injury activity levels in each group, measured in weeks
Change in the Banff Patella Instability Instrument at 2 weeks
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Change in the Banff Patella Instability Instrument at 6 weeks
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Change in the Banff Patella Instability Instrument at 3 months
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Change in the Banff Patella Instability Instrument at 6 months
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Change in the Banff Patella Instability Instrument at 1 year
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Change in the Banff Patella Instability Instrument at 2 years
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Change in the Banff Patella Instability Instrument at 5 years
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Change in the Banff Patella Instability Instrument at 10 years
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Change in Norwich Patellar Instability Score at 2 weeks
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Change in Norwich Patellar Instability Score at 6 weeks
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Change in Norwich Patellar Instability Score at 3 months
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Change in Norwich Patellar Instability Score at 6 months
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Change in Norwich Patellar Instability Score at 1 year
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Change in Norwich Patellar Instability Score at 2 years
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Change in Norwich Patellar Instability Score at 5 years
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Change in Norwich Patellar Instability Score at 10 years
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05533671
Brief Title
Conservative Versus Operative - First Time Patella Dislocations
Official Title
Conservative Versus Surgical Management of First Time Patella Dislocations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
September 2032 (Anticipated)
Study Completion Date
September 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
There is no consensus regarding whether rehabilitation or surgical management is best for the management of a primary patellar dislocation. Consequently this prospective randomized controlled aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).
Detailed Description
Long term sequalae of first-time patellar dislocations include recurrent knee instability, osteoarthritis, and a decreased quality of life, and yet there is no consensus on the best management for these patients. Despite an increasing trend toward investigating operative vs non-operative management of primary patellar dislocations, scarce level-1 evidence exists comparing the two treatment modalities. Indeed, the few meta-analyses suggesting improved outcomes of operative treatment for first time patellar dislocations mainly utilize retrospective cohort studies. A randomized-controlled trial of 39 patients with primary patellar dislocations with a mean age of 24 (21 operative vs 18 non-operative), found decreased rates of recurrent knee instability after a mean follow up of 44 months (0% in operative vs 35% in non-operative), and a higher Kujala knee score (88.9 in operative vs 70.8 in non-operative; p=0.001). A controlled but non-randomized prospective controlled trial among 69 patients with a mean age of 18, (30 operative vs 39 non-operative), found lower rates of recurrent knee instability after a mean follow up of 24 months (0% in operative vs 20.5% in non-operative and a higher Kujala knee score (86.3 in operative group vs 80.03 in non-operative; p <0.05).The scarce randomized, prospective data investigating the appropriate management in primary patellar dislocations underscores the importance of the current study in providing high-quality evidence to the debate of how to best manage primary patellar dislocations. This study aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patella Dislocation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a prospective randomized controlled trial investigating outcomes (recurrent dislocation rates and participant reported outcomes) in two groups of participants following a primary patella dislocation. Half of the participants will be randomized to operative intervention with a standard medial patellofemoral ligament (MPFL) reconstruction and the other half will be randomized to conservative management with a standardized rehabilitation protocol (non-operative group).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Operative Group
Arm Type
Experimental
Arm Description
This group will have surgical procedure called a medial patellofemoral reconstruction where the kneecap is anchored back into its correct position)
Arm Title
Non-operative group
Arm Type
Active Comparator
Arm Description
This group will have physical therapy for their knee dislocation by following a specific rehabilitation plan.
Intervention Type
Procedure
Intervention Name(s)
medial patellofemoral reconstruction
Intervention Description
Surgery to correct dislocated (knocked out of place) knee cap. This surgery anchors the kneecap back into the correct position and supports the kneecap.
Intervention Type
Procedure
Intervention Name(s)
Non-operative group
Intervention Description
Physical therapy by following a specific regimen.
Primary Outcome Measure Information:
Title
Change in Kujala Questionnaire Score at 2 weeks
Description
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time Frame
Baseline and 2 weeks
Title
Change in Kujala Questionnaire Score at 6 weeks
Description
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time Frame
Baseline and 6 weeks
Title
Change in Kujala Questionnaire Score at 3 months
Description
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time Frame
Baseline and 3 months
Title
Change in Kujala Questionnaire Score at 6 months
Description
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time Frame
Baseline and 6 months
Title
Change in Kujala Questionnaire Score at 1 year
Description
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time Frame
Baseline and 1 year
Title
Change in Kujala Questionnaire Score at 2 years
Description
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time Frame
Baseline and 2 years
Title
Change in Kujala Questionnaire Score at 5 years
Description
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time Frame
Baseline and 5 years
Title
Change in Kujala Questionnaire Score at 10 years
Description
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time Frame
Baseline and 10 years
Title
Time to first re-dislocation
Description
Time to first re-dislocation following intervention, measured in weeks
Time Frame
Up to 10 years
Secondary Outcome Measure Information:
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 weeks
Description
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time Frame
Baseline and 2 weeks
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 weeks
Description
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time Frame
Baseline and 6 weeks
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 3 months
Description
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time Frame
Baseline and 3 months
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 months
Description
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time Frame
Baseline and 6 months
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 1 year
Description
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time Frame
Baseline and 1 Year
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 years
Description
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time Frame
Baseline and 2 Years
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 5 years
Description
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time Frame
Baseline and 5 Years
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 10 years
Description
A computerized survey that asks a series of questions pertaining to a patient's physical function through a grading scale of activities of daily living. The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of physical function.
Time Frame
Baseline and 10 Years
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 weeks
Description
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time Frame
Baseline and 2 weeks
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 weeks
Description
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time Frame
Baseline and 6 weeks
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 3 Months
Description
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time Frame
Baseline and 3 Months
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 Months
Description
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time Frame
Baseline and 6 Months
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 1 Year
Description
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time Frame
Baseline and 1 Year
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 Years
Description
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time Frame
Baseline and 2 Years
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 5 Years
Description
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time Frame
Baseline and 5 Years
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 10 Years
Description
A computerized survey that asks a series of questions pertaining to distress a patient may experience as a result of their injury, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10. A higher score is indicative of a greater level of depression.
Time Frame
Baseline and 10 Years
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 weeks
Description
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time Frame
Baseline and 2 weeks
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 weeks
Description
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time Frame
Baseline and 6 weeks
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 3 months
Description
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time Frame
Baseline and 3 months
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 months
Description
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time Frame
Baseline and 6 months
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 1 year
Description
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time Frame
Baseline and 1 year
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 years
Description
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time Frame
Baseline and 2 years
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 5 years
Description
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time Frame
Baseline and 5 years
Title
Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 10 years
Description
A computerized survey that asks a series of questions pertaining to pain a patient may experience from an injury and the way it influences different domains of their life, which can be followed over time to determine the effectiveness of an intervention. The Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) is reported as a T-score with a mean of 50 and a standard deviation of 10.
Time Frame
Baseline and 10 years
Title
Percentage of participants who re-dislocate their knee after treatment at each time point within each group
Description
Percentage of group that experienced re-dislocation after treatment starts at each time point
Time Frame
2 weeks 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Title
Time to return to full activity or sports for each group
Description
Time from treatment initiation to full return to pre-injury activity levels in each group, measured in weeks
Time Frame
Up to 10 years
Title
Change in the Banff Patella Instability Instrument at 2 weeks
Description
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time Frame
Baseline and 2 weeks
Title
Change in the Banff Patella Instability Instrument at 6 weeks
Description
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time Frame
Baseline and 6 weeks
Title
Change in the Banff Patella Instability Instrument at 3 months
Description
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time Frame
Baseline and 3 months
Title
Change in the Banff Patella Instability Instrument at 6 months
Description
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time Frame
Baseline and 6 months
Title
Change in the Banff Patella Instability Instrument at 1 year
Description
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time Frame
Baseline and 1 year
Title
Change in the Banff Patella Instability Instrument at 2 years
Description
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time Frame
Baseline and 2 years
Title
Change in the Banff Patella Instability Instrument at 5 years
Description
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time Frame
Baseline and 5 years
Title
Change in the Banff Patella Instability Instrument at 10 years
Description
Quality of life survey developed in patients with patellofemoral instability that asks patients questions regarding how their patellofemoral injury has affected their life. it is on a scale of 0-100 with higher scores indicating better outcomes.
Time Frame
Baseline and 10 years
Title
Change in Norwich Patellar Instability Score at 2 weeks
Description
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time Frame
Baseline and 2 weeks
Title
Change in Norwich Patellar Instability Score at 6 weeks
Description
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time Frame
Baseline and 6 weeks
Title
Change in Norwich Patellar Instability Score at 3 months
Description
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time Frame
Baseline and 3 months
Title
Change in Norwich Patellar Instability Score at 6 months
Description
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time Frame
Baseline and 6 months
Title
Change in Norwich Patellar Instability Score at 1 year
Description
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time Frame
Baseline and 1 year
Title
Change in Norwich Patellar Instability Score at 2 years
Description
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time Frame
Baseline and 2 years
Title
Change in Norwich Patellar Instability Score at 5 years
Description
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time Frame
Baseline and 5 years
Title
Change in Norwich Patellar Instability Score at 10 years
Description
Symptom survey that asks patients questions pertaining to symptoms they may be experiencing as a result of their knee injury. Scored as a percentage, a higher percentage indicates worse symptoms and therefore a worse outcome.
Time Frame
Baseline and 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 12 and older
patients seen by the Columbia University Shoulder Elbow and Sports Medicine Service
patients who experience a first-time patella dislocation
Exclusion Criteria:
coexistent ligament injury or osteochondral fracture necessitating acute surgical intervention
previous knee surgery
knee instability prior to injury
inability or unwillingness to adhere to study participate
lost to follow up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian A Pearsall, BS, BA
Phone
251-377-6058
Email
cap2263@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Trofa, MD
Organizational Affiliation
Assistant Professor of Orthopedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian A Pearsall, BS, BA
Phone
251-377-6058
Email
cap2263@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
David P Trofa, MD
Phone
914-787-2279
Email
dpt2103@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
David P Trofa, MD
First Name & Middle Initial & Last Name & Degree
Christian A Pearsall, BS, BA
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30460463
Citation
Zheng X, Hu Y, Xie P, Cui M, Ma X, Feng YE, Gu J, Gao S. Surgical medial patellofemoral ligament reconstruction versus non-surgical treatment of acute primary patellar dislocation: a prospective controlled trial. Int Orthop. 2019 Jun;43(6):1495-1501. doi: 10.1007/s00264-018-4243-x. Epub 2018 Nov 20.
Results Reference
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PubMed Identifier
32209111
Citation
Xing X, Shi H, Feng S. Does surgical treatment produce better outcomes than conservative treatment for acute primary patellar dislocations? A meta-analysis of 10 randomized controlled trials. J Orthop Surg Res. 2020 Mar 24;15(1):118. doi: 10.1186/s13018-020-01634-5.
Results Reference
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PubMed Identifier
34604425
Citation
Liu Z, Yi Q, He L, Yao C, Zhang L, Lu F, Zhang X, Wu M, Geng B, Xia Y, Jiang J. Comparing Nonoperative Treatment, MPFL Repair, and MPFL Reconstruction for Patients With Patellar Dislocation: A Systematic Review and Network Meta-analysis. Orthop J Sports Med. 2021 Sep 28;9(9):23259671211026624. doi: 10.1177/23259671211026624. eCollection 2021 Sep.
Results Reference
background
PubMed Identifier
26535352
Citation
Mackay ND, Smith NA, Parsons N, Spalding T, Thompson P, Sprowson AP. Medial Patellofemoral Ligament Reconstruction for Patellar Dislocation: A Systematic Review. Orthop J Sports Med. 2014 Aug 8;2(8):2325967114544021. doi: 10.1177/2325967114544021. eCollection 2014 Aug.
Results Reference
background
PubMed Identifier
22016458
Citation
Bitar AC, Demange MK, D'Elia CO, Camanho GL. Traumatic patellar dislocation: nonoperative treatment compared with MPFL reconstruction using patellar tendon. Am J Sports Med. 2012 Jan;40(1):114-22. doi: 10.1177/0363546511423742. Epub 2011 Oct 19.
Results Reference
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Learn more about this trial
Conservative Versus Operative - First Time Patella Dislocations
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