Does Joint Immobilization Following Revision Total Knee Arthroplasty Improve Range of Motion Following Surgery?

April 20, 2026 updated by: Brian Chalmers, Hospital for Special Surgery, New York

Does Joint Immobilization Following Revision Total Knee Arthroplasty (rTKA) Improve Range of Motion Following Surgery?

The goal of this study is to evaluate if knee immobilization for 10 days following revision total knee arthroplasty (rTKA) improves knee joint range of motion at 3 months postoperatively compared to standard of care postoperative protocol.

Participants will be assigned to one of two groups.

One group will wear a knee brace that keeps the knee straight for 10 days after surgery and will not perform knee range of motion exercises during that time. The other group will not wear a brace and will follow the standard physical therapy program, including knee range of motion exercises, starting after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Knee immobilization after revision total knee arthroplasty (TKA) remains unexplored in the literature despite its potential to address key challenges in the post-operative management and rehabilitation in these patients. Revision TKA is typically associated with higher rates of complications such as instability, malalignment, extensor mechanism disruption, and stiffness. Given the intricate nature of revision procedures and the increased risk of suboptimal outcomes, effective strategies for optimizing functional recovery and minimizing post-operative pain are critical. Semirigid extension bracing, a form of knee immobilization, has shown promise in primary TKA in improving pain management, promoting knee range of motion (ROM), and reducing opioid consumption. However, its role in revision TKA remains unknown. Exploring the use of knee immobilization in the revision TKA population could provide a non-pharmacological, cost-effective approach to addressing pain, minimizing complications, and improving long-term functional outcomes.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Alexis G Gonzalez, MS
        • Sub-Investigator:
          • David A Kolin, MD
        • Sub-Investigator:
          • Gwo-Chin Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing revision TKA for aseptic indications including aseptic loosening, polyethylene wear, instability, malalignment, periprosthetic fracture.
  • Patients undergoing revision TKA of one or both components.

Exclusion Criteria:

  • Patients who are undergoing revision TKA for stiffness.
  • Patients with occult infection not recognized prior to revision.
  • Patients with hinged TKA component reconstructions.
  • Patients undergoing revision for liner exchange.
  • History of VTE/PE.
  • Patients on pre-operative anticoagulation.
  • BMI ≥ 40.
  • Patients with preoperative opioid use equal to or exceeding 150 Morphine Milligram Equivalents (MMEs)/day within 90 days of revision TKA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Participants will wear a knee immobilizer brace for 10 days postoperatively and exclude knee range of motion exercises from postoperative physical therapy protocol during this period. They will resume all standard postoperative protocol after this period.
Device: Knee immobilizer
Participants will wear a knee immobilizer brace for 10 days postoperatively and exclude knee range of motion exercises from postoperative physical therapy protocol during this period. They will resume all standard postoperative protocol after this period.
Placebo Comparator: Control Group
Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.
Device: No Knee Immobilizer
Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion (degrees) - knee joint; measured using digital goniometer
Time Frame: 3 months postoperatively
Active and Passive knee flexion and extension range of motion will be measured in degrees using a standardized digital goniometer at each timepoint.
3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion (degrees) - knee joint; measured using a digital goniometer
Time Frame: 2 weeks, 6 months, and 1 year postoperatively
Active and passive knee flexion and extension will be measured in degrees using a standardized digital goniometer. Measurements will be obtained with the patient seated for flexion and supine for extension at each timepoint.
2 weeks, 6 months, and 1 year postoperatively
Swelling (mid-patellar circumference in centimeters) - knee joint; measured using a flexible measuring tape
Time Frame: 6 weeks, 3 months, 6 months, and 1 year postoperatively
Knee swelling will be measured as mid-patellar circumference (cm) with knee in full extension using a standardized flexible measuring tape at each postoperative timepoint.
6 weeks, 3 months, 6 months, and 1 year postoperatively
Stiffness - Knee Joint
Time Frame: 6 weeks, 3 months, 6 months, and 1 year postoperatively
Incidence of knee stiffness
6 weeks, 3 months, 6 months, and 1 year postoperatively
Wound complications
Time Frame: 6 weeks, 3 months, 6 months, and 1 year postoperatively
Incidence of wound complications
6 weeks, 3 months, 6 months, and 1 year postoperatively
Time to achieve physical therapy milestones
Time Frame: 6 weeks, 3 months, 6 months, and 1 year
6 weeks, 3 months, 6 months, and 1 year
Knee Society Scale Score Delta
Time Frame: 6 weeks, 3 months, 6 months, and 1 year
Delta compared to preoperative value
6 weeks, 3 months, 6 months, and 1 year
Functional Knee Society Scale Score Delta
Time Frame: 6 weeks, 3 months, 6 months, and 1 year
Delta compared to preoperative value
6 weeks, 3 months, 6 months, and 1 year
KOOS Jr. Score Delta
Time Frame: 6 weeks, 3 months, 6 months, and 1 year
Delta compared to preoperative value
6 weeks, 3 months, 6 months, and 1 year
PROMIS-10 Score Delta
Time Frame: 6 weeks, 3 months, 6 months, and 1 year
Delta compared to preoperative value
6 weeks, 3 months, 6 months, and 1 year
VAS Pain Score Delta
Time Frame: 6 weeks, 3 months, 6 months, and 1 year
Delta compared to preoperative value
6 weeks, 3 months, 6 months, and 1 year
Total 90 day opioid consumption
Time Frame: 90 days postoperatively
90 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Collaborators

Orthopaedic Research and Education Foundation (OREF)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-2192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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