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

Formal vs. Home-Based Physical Therapy After Unicompartmental Knee

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Outpatient Physical Therapy; Other: Home Base Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Outpatient Physical Therapy Group; 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; traditional outpatient physical therapy which occurs at a physical therapy office
EXPERIMENTAL: Home Base Physical Therapy Group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Rothman Institute Orthopaedics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (ESTIMATE): August 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: osteoarthritis; unicompartmental knee arthroplasty; home-based physical therapy; outpatient physical therapy; PT (Physical Therapy)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 16021505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO