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临床试验/NCT05216666
NCT05216666招募中不适用

Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis

Sahlgrenska University Hospital2 个研究点 分布在 1 个国家目标入组 580 人开始时间: 2022年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
580
试验地点
2
主要终点
Trendelenburg sign as binary variable (positive/negative)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Trendelenburg sign as binary variable (positive/negative)

时间窗: At 12 months after intervention

Trendelenburg sign negative if the pelvis remains horisontal while standing only on the operated leg with both arms in anatomical postion. If the pelvismcannot be kept horisontal and tilts towards the kontralateral hip the Trendelenburgs sign is regarded as positive.

次要结局

  • Dislocation(Within 12 months from intervention)
  • Gluteus medius avulsion in ultrasound(At 3 months after intervention)
  • Euroqol 5 dimension 5 level index (EQ5D-5L)(At 12 months after intervention)
  • Euroqol visual analog scale (EQVAS)(At 12 months after intervention)
  • University of California Activity Level (UCLA)(At 12 months after intervention)
  • Hip abuction torque(At 3 months after intervention)
  • Trendelenburg sign as binary variable (positive/negative)(At 3 months after intervention)
  • Intraoperative blood loss(Intraoperative)
  • Periprosthetic infection(Within 12 months from intervention)
  • Oxford Hip Score(At 12 months after intervention)
  • Gluteus medius atrophy in Magnetic Resonance Imaging(At 3 months after intervention)

研究者

发起方
Sahlgrenska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Georgios Tsikandylakis, MD PhD

Senior consultant in orthopaedic surgery

Sahlgrenska University Hospital

研究点 (2)

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