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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (11)

• Range of motion (degrees) - knee joint; measured using a digital goniometer [Срок оценки: 2 weeks, 6 months, and 1 year postoperatively]
• Swelling (mid-patellar circumference in centimeters) - knee joint; measured using a flexible measuring tape [Срок оценки: 6 weeks, 3 months, 6 months, and 1 year postoperatively]
• Stiffness - Knee Joint [Срок оценки: 6 weeks, 3 months, 6 months, and 1 year postoperatively]
• Wound complications [Срок оценки: 6 weeks, 3 months, 6 months, and 1 year postoperatively]
• Time to achieve physical therapy milestones [Срок оценки: 6 weeks, 3 months, 6 months, and 1 year]
• Knee Society Scale Score Delta [Срок оценки: 6 weeks, 3 months, 6 months, and 1 year]
• Functional Knee Society Scale Score Delta [Срок оценки: 6 weeks, 3 months, 6 months, and 1 year]
• KOOS Jr. Score Delta [Срок оценки: 6 weeks, 3 months, 6 months, and 1 year]
• PROMIS-10 Score Delta [Срок оценки: 6 weeks, 3 months, 6 months, and 1 year]
• VAS Pain Score Delta [Срок оценки: 6 weeks, 3 months, 6 months, and 1 year]
• Total 90 day opioid consumption [Срок оценки: 90 days postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Hospital for Special Surgery — New York

Публикации

• 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

Идентификаторы

NCT: NCT07552415 · 2024-2192

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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