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OpenTrials
Completed

NCT Number: NCT02883998

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outpatient Physical Therapy

Other

traditional outpatient physical therapy which occurs at a physical therapy office

Home Base Physical Therapy

Other

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

Primary outcomes

  1. Change from baseline in Knee Society Score

    Time frame: at 3 weeks, 3 months, and 1 year after surgery

  2. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: at 3 weeks, 3 months, and 1 year after surgery

  3. Change from baseline in Knee range of motion

    Time frame: at 3 weeks, 3 months, and 1 year after surgery

Secondary outcomes

  1. Complications

    Time frame: Will be assessed at 3 weeks, 3 months, and 1 year after surgery

    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)

  2. Cost comparison

    Time frame: Will be assessed at 3 weeks, 3 months, and 1 year after surgery

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Rothman Institute Orthopaedics

Registry information

Official study title

Formal vs. Home-Based Physical Therapy After Unicompartmental Knee

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2016
Registry last updated
Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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