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

NCT07552415 | Recruiting FDA Device

• 1 other identifier: 2024-2192
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aseptic Revision Knee Arthroplasty; Stiffness Following Revision Knee Arthroplasty

Keywords

revision arthroplasty; stiffness; knee swelling

Outcome Measures

Primary Outcomes (1)

• Range of motion (degrees) - knee joint; measured using digital goniometer

  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 Outcomes (11)

• Range of motion (degrees) - knee joint; measured using a digital goniometer

  2 weeks, 6 months, and 1 year postoperatively

• Swelling (mid-patellar circumference in centimeters) - knee joint; measured using a flexible measuring tape

  6 weeks, 3 months, 6 months, and 1 year postoperatively

• Stiffness - Knee Joint

  6 weeks, 3 months, 6 months, and 1 year postoperatively

• Wound complications

  6 weeks, 3 months, 6 months, and 1 year postoperatively

• Time to achieve physical therapy milestones

  6 weeks, 3 months, 6 months, and 1 year

Study Arms (2)

Study Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.

Device: No Knee Immobilizer

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.

Study Group

No Knee Immobilizer DEVICE

Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Orthopaedic Research and Education Foundation (OREF): collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Related Publications (4)

• Tarazi JM, Chen Z, Scuderi GR, Mont MA. The Epidemiology of Revision Total Knee Arthroplasty. J Knee Surg. 2021 Nov;34(13):1396-1401. doi: 10.1055/s-0041-1735282. Epub 2021 Sep 10.

  PMID: 34507367 BACKGROUND

• Postler A, Lutzner C, Beyer F, Tille E, Lutzner J. Analysis of Total Knee Arthroplasty revision causes. BMC Musculoskelet Disord. 2018 Feb 14;19(1):55. doi: 10.1186/s12891-018-1977-y.

  PMID: 29444666 BACKGROUND

• Healy WL, Della Valle CJ, Iorio R, Berend KR, Cushner FD, Dalury DF, Lonner JH. Complications of total knee arthroplasty: standardized list and definitions of the Knee Society. Clin Orthop Relat Res. 2013 Jan;471(1):215-20. doi: 10.1007/s11999-012-2489-y.

  PMID: 22810157 BACKGROUND

• Kaseb MH, Moharrami A, Mirghaderi SP, Fallah E, Razzaghof M, Moazen Jamshidi MM, Poopak A, Mortazavi SMJ. Effect of joint immobilization using extension splint immediately after total knee arthroplasty on post-operative knee function and pain: a randomized clinical trial. Int Orthop. 2022 Aug;46(8):1749-1759. doi: 10.1007/s00264-022-05428-8. Epub 2022 May 19.

  PMID: 35587284 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)