Back to resultsDoes Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Adult patients with grade 3 and 4 (severe) osteoarthritis and indicated for primary total knee arthroplasty.
Exclusion Criteria:
- Age less than 18 y/o
- Any form of arthritis other than osteoarthritis (traumatic, rheumatic, etc)
- Previous knee surgery
- Inability to personally consent to or participate with therapy due to cognitive impairment, physical disability, intoxication or sedation
- known contraindications would include patients that will be unable to participate with therapy or who will put themselves at significant risk due to therapy (this could be either severe cardiac or respiratory impairment that prevents the patient from ambulating or mental impairment preventing the patients from following instructions
Sites / Locations
- UNC Orthopaedics
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Observational
Physical Therapy
Arm Description
Patients will be asked to continue for 12 weeks of nonoperative medical management without physical therapy. At 12 weeks they will be reevaluated regarding the need for total knee arthroplasty.
Patients will be provided a prescription for 12 weeks of physical therapy at a location of their choice. No set protocol will be issued to allow for adjustments based on patient activity level and the therapist's professional choice. The physical therapy techniques, consisting of active and passive physiological and accessory movements and soft tissue mobilization, active range of motion exercises, muscle strengthening, muscle stretching, and exercises such as riding a stationary bicycle will be applied at the discretion of the treating physical therapist primarily to the knee and surrounding structures.
Outcomes
Primary Outcome Measures
Prevention of surgical intervention questionnaire
Following Physical Therapy or observation, the patients (who are indicated for total knee replacement) will be asked if they desire a surgical intervention or if they would like to continue nonoperative management.
Secondary Outcome Measures
PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score
The PROMIS score incorporates questions from multiple validated instruments of functional outcome. The system was then calibrated to the normal population distribution and has been applied previously to assess lower extremity dysfunction. This will increase our sensitivity in detecting differences between the two groups. The CAT is an adaptive test that responds to previous patient responses to decrease the amount of questions required to obtain a score. This will allow our CAT to last 1-5 minutes as opposed to a longer patient reported score or system. PROMIS has also been utilized in the setting of arthritis and should allow for a greater detection of functional improvement.
Full Information
NCT ID
NCT02377102
First Posted
February 25, 2015
Last Updated
November 10, 2017
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT02377102
Brief Title
Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
Official Title
Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose: For the target population of adult patients with end stage osteoarthritis, this randomized clinical trial will be used to evaluate the benefit of three months of physical therapy compared to no treatment in patients indicated for total knee arthroplasty.
Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for total knee arthroplasty.
Procedures: Patients will be randomized to either receive physical therapy or no treatment. They will be scheduled to return in 3 months for discussion of operative versus continued nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS (Patient Reported Outcome Measurement Information System) score and prevention of surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observational
Arm Type
No Intervention
Arm Description
Patients will be asked to continue for 12 weeks of nonoperative medical management without physical therapy. At 12 weeks they will be reevaluated regarding the need for total knee arthroplasty.
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
Patients will be provided a prescription for 12 weeks of physical therapy at a location of their choice. No set protocol will be issued to allow for adjustments based on patient activity level and the therapist's professional choice. The physical therapy techniques, consisting of active and passive physiological and accessory movements and soft tissue mobilization, active range of motion exercises, muscle strengthening, muscle stretching, and exercises such as riding a stationary bicycle will be applied at the discretion of the treating physical therapist primarily to the knee and surrounding structures.
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Description
12 weeks of supervised physical therapy.
Primary Outcome Measure Information:
Title
Prevention of surgical intervention questionnaire
Description
Following Physical Therapy or observation, the patients (who are indicated for total knee replacement) will be asked if they desire a surgical intervention or if they would like to continue nonoperative management.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score
Description
The PROMIS score incorporates questions from multiple validated instruments of functional outcome. The system was then calibrated to the normal population distribution and has been applied previously to assess lower extremity dysfunction. This will increase our sensitivity in detecting differences between the two groups. The CAT is an adaptive test that responds to previous patient responses to decrease the amount of questions required to obtain a score. This will allow our CAT to last 1-5 minutes as opposed to a longer patient reported score or system. PROMIS has also been utilized in the setting of arthritis and should allow for a greater detection of functional improvement.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients with grade 3 and 4 (severe) osteoarthritis and indicated for primary total knee arthroplasty.
Exclusion Criteria:
Age less than 18 y/o
Any form of arthritis other than osteoarthritis (traumatic, rheumatic, etc)
Previous knee surgery
Inability to personally consent to or participate with therapy due to cognitive impairment, physical disability, intoxication or sedation
known contraindications would include patients that will be unable to participate with therapy or who will put themselves at significant risk due to therapy (this could be either severe cardiac or respiratory impairment that prevents the patient from ambulating or mental impairment preventing the patients from following instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Del Gaizo, MD
Organizational Affiliation
UNC Orthopaedics
Official's Role
Study Director
Facility Information:
Facility Name
UNC Orthopaedics
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
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Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
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