Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability
Primary Purpose
Patella, Joint Instability, Patellofemoral Joint Dislocation
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Return to Sport testbattery
Sponsored by
About this trial
This is an interventional other trial for Patella
Eligibility Criteria
Inclusion Criteria:
- Patients who have undergone surgical treatment for recurrent patellar dislocation in Helse Vest. The investigators will include patients with reconstruction of the medial patella femoral ligament, trochleaplasty, tibial tubercle osteotomy, Insall or concomitant procedures.
Exclusion Criteria:
- Unable to give written informed consent.
- Medial patellar dislocation.
- unable to understand written or spoken Norwegian.
- patients with other knee injuries.
Sites / Locations
- Haraldsplass Deaconess Hospital
Outcomes
Primary Outcome Measures
Banff Patellofemoral Instability Instrument 2.0 change from pre- to postopertaive score
Self-administered, disease-specific quality of life score. It will be administered as a patient completed questionnaire.
Norwich patellar Instability score change from pre- to postopertaive score.
Patient-perceived symptoms of patellar instability during activity. It will be administered as a patient completed questionnaire.
Secondary Outcome Measures
Y-balance test
Evaluates knee stability and asymmetrical balance in three directions (anterior, posteromedial and posterolateral).
Single legged hop tests
Comprises four tasks: single-leg hop for distance, triple hop for distance, triple cross-over hop for distance and six-meter timed hop.
Isokinetic strength test
Strength testing of knee extension / flexion (Biodex system 4 dynamometer, Biodex Medical Systems Inc., Shirley, New York). With a standardized protocol of five repetitions at 60 o/sec and 30 repetitions at 240 o/sec.
IKDC-2000
Is a knee-specific, patient reported tool, including 18 questions across three domains: symptoms, physical activity and function. It will be administered as a patient completed questionnaire.
KOOS
Is an instrument to assess the patient's opinion about their knee and associated problems. It comprises five domains: pain, other symptoms, function in daily living, function in sports and recreational activities and knee-related QOL. It will be administered as a patient completed questionnaire.
Tampa scale of kinesiophobia
TSK is a 17-item patient-reported questionnaire aimed at quantifying the fear of re-injuries due to movement and physical activity. It will be administered as a patient completed questionnaire.
Full Information
NCT ID
NCT05119088
First Posted
October 5, 2021
Last Updated
February 28, 2023
Sponsor
Haraldsplass Deaconess Hospital
Collaborators
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05119088
Brief Title
Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability
Official Title
Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haraldsplass Deaconess Hospital
Collaborators
Haukeland University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
About six months after patella stabilizing surgery postoperative restrictions are commonly lifted and patients may consider whether a return to activity/sports is feasible. Currently, there are no evidence-based criteria to determine a patients readiness for sports and/or activity (RTS) following stabilizing surgery. The purpose of this project was therefore to investigate the feasibility of a test battery to evaluate knee function in postoperative follow-up evaluation - and in RTS decisions - for patients with patellar instability. Banff Patellofemoral Instability Instrument 2.0 and Norwich Patellar Instability Score is being translated and validatend in a Norwegian population. Furter is patients experience of living with patellar instability explored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patella, Joint Instability, Patellofemoral Joint Dislocation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Return to Sport testbattery
Other Intervention Name(s)
Validation of Banff Patellofemoral Instability Instrument 2.0 - No, Validation of Norwich Instability Score - No
Intervention Description
At baseline, approximately 3 weeks before surgery and 6 months after surgery: patients conduct a testbattery consisting of 2 PROMs: the NPI-No and BPII2.0-No together with three physical tests: isokinetic strength tests, hop tests and Y-balance test. For the cross-cultural validation of NPI and BPII2.0 patients also conduct KOOS, IKDC 2000 and Tampa Scale.
Primary Outcome Measure Information:
Title
Banff Patellofemoral Instability Instrument 2.0 change from pre- to postopertaive score
Description
Self-administered, disease-specific quality of life score. It will be administered as a patient completed questionnaire.
Time Frame
Baseline and 6 months after surgery.
Title
Norwich patellar Instability score change from pre- to postopertaive score.
Description
Patient-perceived symptoms of patellar instability during activity. It will be administered as a patient completed questionnaire.
Time Frame
Baseline and 6 months after surgery.
Secondary Outcome Measure Information:
Title
Y-balance test
Description
Evaluates knee stability and asymmetrical balance in three directions (anterior, posteromedial and posterolateral).
Time Frame
Baseline and 6 months after surgery.
Title
Single legged hop tests
Description
Comprises four tasks: single-leg hop for distance, triple hop for distance, triple cross-over hop for distance and six-meter timed hop.
Time Frame
Baseline and 6 months after surgery.
Title
Isokinetic strength test
Description
Strength testing of knee extension / flexion (Biodex system 4 dynamometer, Biodex Medical Systems Inc., Shirley, New York). With a standardized protocol of five repetitions at 60 o/sec and 30 repetitions at 240 o/sec.
Time Frame
Baseline and 6 months after surgery.
Title
IKDC-2000
Description
Is a knee-specific, patient reported tool, including 18 questions across three domains: symptoms, physical activity and function. It will be administered as a patient completed questionnaire.
Time Frame
Baseline and 6 months after surgery.
Title
KOOS
Description
Is an instrument to assess the patient's opinion about their knee and associated problems. It comprises five domains: pain, other symptoms, function in daily living, function in sports and recreational activities and knee-related QOL. It will be administered as a patient completed questionnaire.
Time Frame
Baseline and 6 months after surgery.
Title
Tampa scale of kinesiophobia
Description
TSK is a 17-item patient-reported questionnaire aimed at quantifying the fear of re-injuries due to movement and physical activity. It will be administered as a patient completed questionnaire.
Time Frame
Baseline and 6 months after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who have undergone surgical treatment for recurrent patellar dislocation in Helse Vest. The investigators will include patients with reconstruction of the medial patella femoral ligament, trochleaplasty, tibial tubercle osteotomy, Insall or concomitant procedures.
Exclusion Criteria:
Unable to give written informed consent.
Medial patellar dislocation.
unable to understand written or spoken Norwegian.
patients with other knee injuries.
Facility Information:
Facility Name
Haraldsplass Deaconess Hospital
City
Bergen
ZIP/Postal Code
5008
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability
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