Does Joint Immobilization Following Revision Total Knee Arthroplasty Improve Range of Motion Following Surgery?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Knee immobilizer, No Knee Immobilizer.
- Who it may be relevant to
- Registry conditions: Aseptic Revision Knee Arthroplasty, Stiffness Following Revision Knee Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Does Joint Immobilization Following Revision Total Knee Arthroplasty (rTKA) Improve Range of Motion Following Surgery?
Overview
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.
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.
Interventions
- 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. - Device No Knee Immobilizer
Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.
Primary outcome measures
- Range of motion (degrees) - knee joint; measured using digital goniometer [Time frame: 3 months postoperatively]
Secondary outcome measures (11)
- Range of motion (degrees) - knee joint; measured using a digital goniometer [Time frame: 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]
- Stiffness - Knee Joint [Time frame: 6 weeks, 3 months, 6 months, and 1 year postoperatively]
- Wound complications [Time frame: 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]
- Knee Society Scale Score Delta [Time frame: 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]
- KOOS Jr. Score Delta [Time frame: 6 weeks, 3 months, 6 months, and 1 year]
- PROMIS-10 Score Delta [Time frame: 6 weeks, 3 months, 6 months, and 1 year]
- VAS Pain Score Delta [Time frame: 6 weeks, 3 months, 6 months, and 1 year]
- Total 90 day opioid consumption [Time frame: 90 days postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Hospital for Special Surgery — New York
Publications
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07552415 · 2024-2192