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Идёт набор NCT05216666

The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty

Без фазы С лечением Hip Osteoarthritis Muscle Weakness Muscle Atrophy Muscle Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lateral approach, Posterior approach.
Кому может быть актуально
Состояния в реестре: Hip Osteoarthritis, Muscle Weakness, Muscle Atrophy, Muscle Injury. Базовые параметры: 40 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis

Обзор

Residual limping after total hip arthroplasty is empirically associated with the use of lateral approach but has been reported in litterature even with the use of posterior approach. The purpose of this clinical trial is to compare the risk of residual limping one year after total hip arthropasty between lateral and posterior approach.

Подробное описание

The use of lateral approach has been empirically associated with increased risk of abductor insufficiency and limping after total hip arthroplasty compared with the posterior approach. However lateral approach remains a widespread technik because it provides a decreased risk of dislocation. In litterature, gluteus medius insufficiency has been reported even when the posterior approach has been used. In the early stage of postperative relhabilitation it is difficult to distinguish between between limping that resolves after abductor training and limping due to abductor injury/avulsion that is resistent to physiotherapy. The purpose of this randomized controlled trial is to compare the risk of persistent limping one year after total hip arthtoplasty between lateral and posterior approach and to identify patient-related risk factors for limping. Moreover it will validate ultra sound (U/S), magnetic resonance imaging (MRI) of the hip and gait analysis as diagnostic tools for early detection of limping that is going to persist one year after total hip arthroplasty.

580 patients will hip osteoarthritis be randomised to receive their total hip arthroplasty through an either lateral of posterior approach and will be followed at one year with physical examination (Trendelenburg sign) and patient.-reported outcome measures. Patients with a positive Trendelenburg sign at 3 months will undergo U/S and MRI examination as well as gait analysis and reassessed at one year with physical examination. The first 40 patients with negative Trendelenburg sign at 3 months will also undergo U/S, MRI and gait analysis. The specificity and sensitivity of U/S, MRI and gait analysis for positiv Trendelenburg sign will be calculated.

Вмешательства

  • Процедура Lateral approach
    Total hip arthroplasty performed through a lateral surgical approach (Gammer)
  • Процедура Posterior approach
    Total hip arthroplasty performed through a posterior surgical approach (Moore)

Первичные конечные точки

  • Trendelenburg sign as binary variable (positive/negative) [Срок оценки: At 12 months after intervention]
Вторичные конечные точки (12)
  • Dislocation [Срок оценки: Within 12 months from intervention]
  • Intraoperative blood loss [Срок оценки: Intraoperative]
  • Periprosthetic infection [Срок оценки: Within 12 months from intervention]
  • Oxford Hip Score [Срок оценки: At 3 months after intervention]
  • Oxford Hip Score [Срок оценки: At 12 months after intervention]
  • Euroqol 5 dimension 5 level index (EQ5D-5L) [Срок оценки: At 3 months after intervention]
  • Euroqol 5 dimension 5 level index (EQ5D-5L) [Срок оценки: At 12 months after intervention]
  • Euroqol visual analog scale (EQVAS) [Срок оценки: At 3 months after intervention]
  • Euroqol visual analog scale (EQVAS) [Срок оценки: At 12 months after intervention]
  • University of California Activity Level (UCLA) [Срок оценки: At 3 months after intervention]
  • University of California Activity Level (UCLA) [Срок оценки: At 12 months after intervention]
  • Gluteus medius avulsion in ultrasound [Срок оценки: At 3 months after intervention]

Критерии участия

Критерии включения

  • Primary unilateral osteoarthritis of the hip scheduled for total hip arthroplasty.
  • Ability to understand and write swedish.

Критерии исключения

  • Impaired funktion of the contralateral hip or knees causing limping.
  • Neuromuscular diseases
  • Postoperative leg length discrepancy excceding 1 cm
  • Postoperative discrepancy in femoral offset exceeding 25% of the femoral offset of the contralateral hip.

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

Швеция · 1 центр
  • Sahlgrenska University Hospital — Mölndal

Публикации

  • Hailer NP, Weiss RJ, Stark A, Karrholm J. The risk of revision due to dislocation after total hip arthroplasty depends on surgical approach, femoral head size, sex, and primary diagnosis. An analysis of 78,098 operations in the Swedish Hip Arthroplasty Register. Acta Orthop. 2012 Oct;83(5):442-8. doi: 10.3109/17453674.2012.733919. Epub 2012 Oct 8. PMID 23039167
  • Zijlstra WP, De Hartog B, Van Steenbergen LN, Scheurs BW, Nelissen RGHH. Effect of femoral head size and surgical approach on risk of revision for dislocation after total hip arthroplasty. Acta Orthop. 2017 Aug;88(4):395-401. doi: 10.1080/17453674.2017.1317515. Epub 2017 Apr 25. PMID 28440704
  • Skoogh O, Tsikandylakis G, Mohaddes M, Nemes S, Odin D, Grant P, Rolfson O. Contemporary posterior surgical approach in total hip replacement: still more reoperations due to dislocation compared with direct lateral approach? An observational study of the Swedish Hip Arthroplasty Register including 156,979 hips. Acta Orthop. 2019 Oct;90(5):411-416. doi: 10.1080/17453674.2019.1610269. Epub 2019 May PMID 31060427
  • Moerman S, Mathijssen NMC, Tuinebreijer WE, Vochteloo AJH, Nelissen RGHH. Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision. Acta Orthop. 2018 Oct;89(5):509-514. doi: 10.1080/17453674.2018.1499069. Epub 2018 Aug 6. PMID 30080985
  • Whiteside LA, Roy ME. Incidence and treatment of abductor deficiency during total hip arthroplasty using the posterior approach: repair with direct suture technique and gluteus maximus flap transfer. Bone Joint J. 2019 Jun;101-B(6_Supple_B):116-122. doi: 10.1302/0301-620X.101B6.BJJ-2018-1511.R1. PMID 31146555
  • Ewen AM, Stewart S, St Clair Gibson A, Kashyap SN, Caplan N. Post-operative gait analysis in total hip replacement patients-a review of current literature and meta-analysis. Gait Posture. 2012 May;36(1):1-6. doi: 10.1016/j.gaitpost.2011.12.024. Epub 2012 Mar 10. PMID 22410129

Идентификаторы

NCT: NCT05216666 · 277461

Первоисточники (государственные реестры)

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