Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
|ClinicalTrials.gov Identifier: NCT02377102|
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : November 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Procedure: Physical Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
No Intervention: Observational
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.
Active Comparator: Physical Therapy
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.
Procedure: Physical Therapy
12 weeks of supervised physical therapy.
- Prevention of surgical intervention questionnaire [ Time Frame: 12 weeks ]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.
- PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score [ Time Frame: 12 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377102
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Study Director:||Daniel J Del Gaizo, MD||UNC Orthopaedics|