Clinical trial NCT02883998: Formal vs. Home-Based Physical Therapy After Unicompartmental Knee Arthroplasty
Official title: Formal vs. Home-Based Physical Therapy After Unicompartmental Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: home-based physical therapy
outpatient physical therapy
unicompartmental knee arthroplasty
PT (Physical Therapy)
osteoarthritis
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Rothman Institute Orthopaedics
First posted: 2016-08-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Knee Society Score
timeFrame: at 3 weeks, 3 months, and 1 year after surgery
measure: Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: at 3 weeks, 3 months, and 1 year after surgery
measure: Change from baseline in Knee range of motion
timeFrame: at 3 weeks, 3 months, and 1 year after surgery
Secondary outcomes:
measure: Complications
timeFrame: Will be assessed at 3 weeks, 3 months, and 1 year after surgery
measure: Cost comparison
timeFrame: Will be assessed at 3 weeks, 3 months, and 1 year after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Craig Della Valle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.