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临床试验/NCT04638114
NCT04638114撤回不适用

Mini- Open Direct-anterior Approach vs Hip Arthroscopy for Treatment of Femoroacetabular Impingement. A Prospective Randomized Controlled Trial With 2 Years Follow up

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家开始时间: 2012年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Validated outcome score

研究概览

简要总结

Femoroacetabular impingement (FAI) is increasingly recognized as a common hip condition affecting the adolescent and adult population with groin pain and disability 1-5. When nonsteroidal anti-inflammatory medications, activity modification and injections fail as conservative treatment option fails, surgery addressing the underlying osseous pathoanatomy and associated labral and chondral lesions may be necessary.

Several techniques have been described as treatment of this condition. The first technique termed surgical hip dislocation (SHD) allowed to describe the pathomechanism of FAI 1, 3, 5, 6 and to develop treatment strategies such as osteochondroplasty, acetabular rim resection and fixation of torn labrum. Other techniques also have been proposed and consist of less invasive techniques as the (mini-open) direct anterior approach 7-10 and ´the golden standard´; the hip arthroscopy 11-15.

Good results have been reported for all techniques but faster rehabilitation and less morbidity have been published for hip arthroscopy (HA). The direct anterior approach also shows good results but a good randomized controlled trial to compare both techniques has not yet been performed.

Outcome is meanly determined by adequate bony correction of cam and pincer deformities. Direct visualization during SHD offers the advantage that possibly a more appropriate correction of the underlying morphology can be done. This thereby decreases the likelihood of early hip osteoarthritis (OA).

The purpose of the present study was to test the hypothesis that 1) the postoperative recovery and short term outcome after HA is superior compared to mini-open direct anterior approach and 2) the morphological corrections achieved by HA are equally sufficient when compared to the corrections achieved by the mini-open direct anterior technique.

详细描述

Hip arthroscopy versus mini-open direct anterior approach Surgical approach can have an important effect on post-operative recovery, complications and overall morbidity. Two frequently used approaches will be compared in the proposed study: the HA and the mini-open direct anterior approach. Outcome of HA vs mini-open direct anterior can thus be divided into clinical and morphological outcome parameters.

The clinical outcome parameters should be divided in early and long term outcome.

The early outcome is especially related to the surgery itself and postoperative rehabilitation. Outcome parameters are complication rate, hospital stay, blood loss, transfusion rate and functional recovery. The easiest way to describe functional outcome is by using internationally recognized and validated outcome scores. They are developed as an instrument to assess the patient's opinion about their hip and associated problems. These validated scores aim to assess the functionality and disability of the hip. The functional short and long term results of surgical procedures can be monitored with these outcome scores. In this study we use the Harris Hip Score, Hip disability and Osteoartritis Outcome Score (HOOS) and The Western Ontario and MacMaster (WOMAC) score. The Harris Hip Score (HHS) is probably one of the most frequently used scores to assess the outcome of procedures related to the hip joint16. Finally, the Hip disability and Osteoarthritis Outcome Score (HOOS) is a validated scoring system that consists of 39 items, divided into 5 sub-scales (i.e. pain, other symptoms, activity limitations in daily living (ADL), activity limitations in recreation and sport, and hip-related quality of life (QoL))17. The Western Ontario and MacMaster (WOMAC) is also a frequently used outcome tool and can be subtracted from the HOOS score18.

The late (>1 year) outcome parameters are the late complication rate and conversion to arthroplasty.

The morphological outcome is determined on anteroposterior pelvic x-rays and cross-table lateral views acquired preoperatively and 6 weeks after surgery. Several specific signs will be recorded. The presence of a cross-over sign 19 (COS), a posterior wall sign 19 (PWS), a prominence of the ischial spine 23 (PRISS) and a herniation pit 24 will be noted. Supplementary the CE-Angle 25, AC-Index 26, and quantitative COS 27 and the OA grade according to Tönnis 20 will be assessed. Additionally, the resection width angle 28 and the resection depth ratio 28 will be determined as schematically presented in Table 1.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Age: 15-80 years
  • Gender: 1:1 ratio of males and females / cohort
  • BMI: <30kg/m
  • Symptomatic FAI proven by clinical examination, plain radiographs and positive arthro-CT examination.
  • Clinical inclusion criteria: A positive impingement sign together with hip internal rotation in the 90° flexed hip position of less than 10° are the main clinical criteria.
  • Morphologic inclusion: a cam deformity (alpha angle higher 55°) 17 on radial arthro CT together with corresponding chondrolabral lesions

排除标准

  • 未提供

研究组 & 干预措施

CAM lesion

Experimental

Mini-Open DAA Hip Arthroscopy

干预措施: Mini-open DAA (Procedure)

PINCER impingement

Other

Mini-Open DAA Hip Arthroscopy

干预措施: Mini-open DAA (Procedure)

PINCER impingement

Other

Mini-Open DAA Hip Arthroscopy

干预措施: Hip arthroscopy (Procedure)

CAM lesion

Experimental

Mini-Open DAA Hip Arthroscopy

干预措施: Hip arthroscopy (Procedure)

结局指标

主要结局

Validated outcome score

时间窗: 2 year

Clinical outcome

次要结局

  • Radiographic measurement(2 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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