Formal vs. Home-Based Physical Therapy After Unicompartmental Knee Arthroplasty

Study Overview
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Brief Summary
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To determine whether home-based physical therapy (HBPT) is not clinically inferior to formal outpatient physical therapy (OPT) after hospital discharge of patients undergoing a unicompartmental knee arthroplasty (UKA).

Detailed Description
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Given that current practice trends are requiring treatments to be both clinically and cost effective, research has begun to focus on evaluating the effect of specific interventions. Many surgeon and patients have believed formal OPT is necessary to optimize functional outcomes following orthopaedic procedures. However, the literature has begun to call into question the need for OPT following total hip arthroplasty, total knee arthroplasty, total shoulder arthroplasty, anterior cruciate ligament reconstruction, meniscectomy, and rotator cuff repair. A randomized controlled trial was done to compare face-to-face rehabilitation with in-home telerehabilitation following total knee arthroplasty. Utilizing the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as the primary outcome, the authors demonstrated noninferiority of telerehabilitation compared to face-to-face rehabilitation. Other secondary outcomes of Knee Injury and Osteoarthritis Outcome Score (KOOS), range of motion, and isometric strength did not exhibit a difference between the treatment groups. (see citation below) Based on these findings, it appears that the high cost of formal OPT doesn't translate into a meaningful improvement of functional outcome. Because patient's undergoing UKA have a higher pre-operative functional status than patients having a TKA (Total Knee Arthroplasty), it is reasonable to think that patients following a UKA are better equipped to succeed with HBPT. As a result, the hypothesis of the current study is that HBPT will prove to be non-inferior to formal OPT in the setting of UKA.

Official Title
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Formal vs. Home-Based Physical Therapy After Unicompartmental Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Outpatient Physical Therapy
* Other: Home Base Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for a unicompartmental knee arthroplasty Exclusion Criteria: Require inpatient physical therapy beyond post-operative day one < 18 years old Decline to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Outpatient Physical Therapy Group<br>Once the patient is cleared for discharged from the hospital, the patient will be given a prescription for outpatient physical therapy to attend 3 times per week for 6 weeks. | Other: Outpatient Physical Therapy<br>* traditional outpatient physical therapy which occurs at a physical therapy office<br>|
| Experimental: Home Base Physical Therapy Group<br>Patients will be provided a packet of exercises and equipment to perform the home based physical therapy program. Patients will attend a single session of outpatient physical therapy prior to surgery no more than 4 weeks prior to the procedure to teach the patient how to perform the exercises. | Other: Home Base Physical Therapy<br>* Patients will be provided a packet of exercises via a website which allows access to instructional physical therapy videos specifically designated for UKA patients and equipment to perform the home based physical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Knee Society Score |  | at 3 weeks, 3 months, and 1 year after surgery | 
| Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index |  | at 3 weeks, 3 months, and 1 year after surgery | 
| Change from baseline in Knee range of motion |  | at 3 weeks, 3 months, and 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Deep Vein Thrombosis or Pulmonary Embolus Return to the OR within 30 days Re-admission within 30 days Superficial infection Deep infection Periprosthetic fracture Knee stiffness (defined as < 90 degrees flexion at 3 weeks post-operative or < 110 degrees flexion at 6 weeks post-operative) | Will be assessed at 3 weeks, 3 months, and 1 year after surgery | 
| Cost comparison |  | Will be assessed at 3 weeks, 3 months, and 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home-based physical therapy, outpatient physical therapy, unicompartmental knee arthroplasty, PT (Physical Therapy), osteoarthritis