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

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT07552415
Status
Recruiting

Conditions

  • Aseptic Revision Knee Arthroplasty
  • Stiffness Following Revision Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Knee immobilizer — DEVICE
    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.
  • No Knee Immobilizer — DEVICE
    Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • Placebo Comparator: Control Group
    Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.

Primary Outcome Measure

Range of motion (degrees) - knee joint; measured using digital goniometer [ Time Frame: 3 months postoperatively ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
Dr. Brian P. Chalmers MD
212-606-1999
Allina Nocon, PhD
646-714-6015
Alexis G Gonzalez, MS (SUB_INVESTIGATOR)
David A Kolin, MD (SUB_INVESTIGATOR)
Gwo-Chin Lee, MD (SUB_INVESTIGATOR)

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