Total Versus Robotic Assisted Unicompartmental Knee Replacement

Официальное название

Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER) for Medial Compartment Osteoarthritis: Randomised Controlled Trial

Обзор

The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.

Подробное описание

Unicompartmental knee arthroplasty (UKA) is an accepted surgical alternative to total knee arthroplasty (TKA) for patients with isolated medial compartmental joint disease with the potential advantages of accelerated recovery, improved functional outcomes and retention of anatomical knee kinematics. However, some surgeons continue to favour TKA over UKA due to a lower revision rate. The higher revision rates associated with UKA are thought to be primarily due to component malpositioning and postoperative limb malalignment.

Robotic-arm assisted (r)UKA offers a greater level of precision of component positioning compared to manual UKA and more recently the survivorship of rUKA has been shown to be greater than manual UKA. Early functional outcomes following robotic UKA appear to be better than those observed after manual TKA. Therefore, the benefits of UKA could potentially be enjoyed by the patient without the increased risk of revision when compared to TKA for those with medical compartment disease.

The primary aim of this study is to compare the early knee specific functional outcome of rUKA with manually performed (m)TKA when performed for patients with medial compartment osteoarthritis of the knee.

A single centre randomised control trial will be carried out powered to the Oxford knee score.

Вмешательства

• Устройство MAKO™ Partial Knee Arthroplasty
  The robotic-arm will be used to position a partial knee arthroplasty.
• Устройство Triathlon (Stryker) Total Knee Arthroplasty
  Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert.

Первичные конечные точки

• Oxford knee score [Срок оценки: Baseline to 6 months]

Вторичные конечные точки (8)

• Oxford knee score and Activity and Participation Questionnaire [Срок оценки: Baseline to 3, 6 and 12 months]
• Forgotten Joint Score [Срок оценки: Baseline to 3, 6 and 12 months]
• Patient satisfaction [Срок оценки: 3, 6 and 12 months]
• EQ-5D-3L [Срок оценки: Baseline to 3, 6 and 12 months]
• Range of movement [Срок оценки: Baseline to 3, 6 and 12 months]
• Cost effectiveness [Срок оценки: Baseline to 3, 6 and 12 months, and projected for the patients lifetime]
• Knee stability and power [Срок оценки: Baseline to 3, 6 and 12 months]
• Patient expectation pre-operative and fulfilment [Срок оценки: Baseline to 3, 6 and 12 months]

Критерии участия

Критерии включения

• Listed for elective primary TKA for end stage medial compartment osteoarthritis
• Intact anterior cruciate ligament
• Full thickness and good quality lateral cartilage
• Correctable intra-articular varus deformity and intact medial collateral ligament
• American Society of Anesthesiologists (ASA) grades 1 and 2
• Male or female, age 50 - 75 at the time of listing for surgery
• Suitable candidate for a cruciate retaining TKA (Triathlon prosthesis) and a UKA

Критерии исключения

• Varus deformity of > 20 degrees
• Fixed flexion of >10 degrees
• Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments
• Female participants who are pregnant, lactating or planning pregnancy during the course of the study
• Requires patella resurfacing or lateral compartment has significant OA
• Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
• Inflammatory disorder e.g. rheumatoid arthritis
• Symptomatic foot, hip or spine pathology
• Prior surgery (other than arthroscopy) or septic arthritis of the knee
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study,

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Nicholas Clement — Edinburgh

Публикации

• Robinson PG, Clement ND, Hamilton D, Blyth MJG, Haddad FS, Patton JT. A systematic review of robotic-assisted unicompartmental knee arthroplasty: prosthesis design and type should be reported. Bone Joint J. 2019 Jul;101-B(7):838-847. doi: 10.1302/0301-620X.101B7.BJJ-2018-1317.R1. PMID 31256672
• Clement ND, Bell A, Simpson P, Macpherson G, Patton JT, Hamilton DF. Robotic-assisted unicompartmental knee arthroplasty has a greater early functional outcome when compared to manual total knee arthroplasty for isolated medial compartment arthritis. Bone Joint Res. 2020 May 16;9(1):15-22. doi: 10.1302/2046-3758.91.BJR-2019-0147.R1. eCollection 2020 Jan. PMID 32435451
• Clement ND, Deehan DJ, Patton JT. Robot-assisted unicompartmental knee arthroplasty for patients with isolated medial compartment osteoarthritis is cost-effective: a markov decision analysis. Bone Joint J. 2019 Sep;101-B(9):1063-1070. doi: 10.1302/0301-620X.101B9.BJJ-2018-1658.R1. PMID 31474149
• Clement ND; TRAKER Research Group; Scott CEH, Macpherson GJ, Simpson PM, Leitch G, Patton JT, Ahmed I, Amin AK, Gaston P, Goudie E, Goudie S, Macdonald DM, Martinson E, Moran M, Wade F. Total versus robotic-assisted unicompartmental knee replacement (TRAKER) for medial compartment osteorthritis: a randomized controlled trial. Bone Jt Open. 2025 Feb 10;6(2):164-177. doi: 10.1302/2633-1462.62.BJO-20 PMID 39923804

Идентификаторы

NCT: NCT05290818 · AC19080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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