Comparison of Restricted Versus Unrestricted Kinematic Alignment in 1ry TKA

Официальное название

Comparison of Restricted Kinematic Alignment Versus Unrestricted Kinematic Alignment in Primary Total Knee Arthroplasty:- Randomized Controlled Trial

Обзор

Knee osteoarthritis is a growing socioeconomic burden because of the ageing and obesity. By 2030, the majority of individuals undergoing knee arthroplasty in USA will be those younger than 65 years, with up to 1 million achieved annually. The definitive treatment for knee joint degeneration is total knee arthroplasty.

Подробное описание

Furthermore, the commonest technique is neutral mechanical alignment total knee arthroplasty. Latest studies have revealed that the mechanical alignment technique repeatedly causing substantial anatomical alterations with a widespread of complex collateral ligament imbalances, which are not repairable by collateral ligament release. Consequently, the total knee arthroplasty individuals walk with an abnormal gait, and they do not experience a normal knee joint. This may be one of the causes that up to 20% of total knee arthroplasty individuals are disappointed, and over 50% may have remaining symptoms.

Consequently, the conventional mechanical alignment technique has been recently challenged by a new alternative technique, namely unrestricted kinematic alignment proposed by Howell, as a possible solution to the high dissatisfaction following total knee arthroplasty, aiming at reproducing the constitutional tibiofemoral tridimensional alignment and knee laxity. It is almost a pure bone procedure with only exceptional collateral ligament release, which has been shown to reliably position knee components.

The restricted kinematic alignment protocol suggested by Vendittoli has been developed as an alternative to the unrestricted kinematic alignment for patients with an outlier or atypical knee anatomy. The restricted kinematic alignment is founded on five principles: hip-knee-ankle angle should be maintained within ± 3° postoperatively; a limitation to a maximum of 5° for lateral distal femoral angle and medial proximal tibial angle may be considered; restoration of collateral ligament balance should be achieved without the gap balancing technique; native femoral anatomy preservation is suggested over tibial one to maintain knee biomechanics; resurface resection must be accomplished on the unworn side with a thickness equivalent to the width of the implant;cut fine-tuning may be sought at the worn side.

Вмешательства

• Процедура Total knee arthroplasty
  Total knee arthroplasty (TKA) is a common orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic

Первичные конечные точки

• Oxoford knee score [Срок оценки: 12 months]

Вторичные конечные точки (2)

• Knee Injury and Osteoarthritis Outcome Score [Срок оценки: 24 months]
• Forgotten Joint Score [Срок оценки: 24 months]

Критерии участия

Критерии включения

-Patients suffered from end stage knee osteoarthritis of grade four according to Kellgren-Lawrence classification in at least one of the three knee compartments, who have an osteoarthritic knees of varus Coronal Plane Alignment of the Knee classification

Критерии исключения

• Any valgus malalignment of the knee joint.
• Malalignment more than 10° or less than 3° varus of knee joint.
• Ligamentous laxity of the affected knee (medial or lateral collateral ligaments)
• any tumors or secondary neoplasia diseases
• Knee joint infection
• severe cardiopulmonary dysfunction.

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Howell SM HM. Kinematic alignment in TKA: definition, surgical technique, and challenging cases.. Orthopedic Knowledge Online. 2012; 10(7).
• Risitano S, Cacciola G, Sabatini L, Capella M, Bosco F, Giustra F, Masse A, Vaishya R. Restricted kinematic alignment in primary total knee arthroplasty: A systematic review of radiographic and clinical data. J Orthop. 2022 Jul 2;33:37-43. doi: 10.1016/j.jor.2022.06.014. eCollection 2022 Sep-Oct. PMID 35812351
• Albishi W, AbuDujain NM, Arafah O, Alshaygy IS, Aldosari ZA, Alhuqbani MN, Alangari SM. Cross-cultural adaptation, validity and reliability of the Arabic version of the Forgotten Joint Score for knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Oct;31(10):4312-4318. doi: 10.1007/s00167-023-07484-y. Epub 2023 Jun 17. PMID 37329371
• Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13. PMID 22000572
• Almangoush A, Herrington L, Attia I, Jones R, Aldawoudy A, Abdul Aziz A, Waley A. Cross-cultural adaptation, reliability, internal consistency and validation of the Arabic version of the knee injury and osteoarthritis outcome score (KOOS) for Egyptian people with knee injuries. Osteoarthritis Cartilage. 2013 Dec;21(12):1855-64. doi: 10.1016/j.joca.2013.09.010. Epub 2013 Oct 2. PMID 24095836
• Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88. PMID 9699158
• Ahmed KM, Said HG, Ramadan EKA, Abd El-Radi M, El-Assal MA. Arabic translation and validation of three knee scores, Lysholm Knee Score (LKS), Oxford Knee Score (OKS), and International Knee Documentation Committee Subjective Knee Form (IKDC). SICOT J. 2019;5:6. doi: 10.1051/sicotj/2018054. Epub 2019 Mar 8. PMID 30848244
• Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998 Jan;80(1):63-9. doi: 10.1302/0301-620x.80b1.7859. PMID 9460955

Идентификаторы

NCT: NCT06726993 · 04-2024-100320

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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