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

Osteoarthritis Clinical Trial

Official title:

Formal vs. Home-Based Physical Therapy After Unicompartmental Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883998
• Other study ID #: 16021505
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Outpatient Physical Therapy
traditional outpatient physical therapy which occurs at a physical therapy office
• 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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Moffet H, Tousignant M, Nadeau S, Mérette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile ÉL, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Knee Society Score		at 3 weeks, 3 months, and 1 year after surgery
Primary	Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index		at 3 weeks, 3 months, and 1 year after surgery
Primary	Change from baseline in Knee range of motion		at 3 weeks, 3 months, and 1 year after surgery
Secondary	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
Secondary	Cost comparison		Will be assessed at 3 weeks, 3 months, and 1 year after surgery