The Arthroscopic Labral Excision or Repair Trial (ALERT) - A Randomised Controlled Trial to Determine the Effectiveness of Arthroscopic Hip Labral Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Hip Outcome Score
研究概览
简要总结
This study compares two established surgical treatments for acetabular labral tears. Patients will be prospectively recruited and randomised to either labral repair or debridement. All patients will be followed for 2 years after intervention with a primary outcome assessment at 6 months.
详细描述
STUDY DESIGN
Study design This will be a two-arm randomised controlled parallel group superiority study and will take place in a hospital setting. Stratification will be performed for sex and age by means of a minimisation technique during randomisation for each subject entering the trial.
Study population:
Adults between 18 and 75 years of age diagnosed with symptomatic acetabular labral tears demonstrated on MRI arthrogram but without radiographic evidence of OA ie: Kellgren & Lawrence grade less than 2 randomly selected from the Nuffield Orthopaedic Centre outpatient clinics.
Arm 1 Arthroscopic acetabular labral repair.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give informed consent for participation in the study.
- •Male or Female, aged between 18 and 75 years.
- •Symptomatic labral tear with evidence of labral tear on MRI.
- •No radiographic evidence of OA (Kellgren-Lawrence Grade < 2)
排除标准
- •Previous ipsilateral hip surgery
- •Irreparable labral tear
- •Previous fracture of femoral neck or acetabulum
- •Female patient who is pregnant
- •Established osteoarthritis (Kellgren-Lawrence ≥ 2)
- •Hip dysplasia
研究组 & 干预措施
Arthroscopic acetabular labral repair
Acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).
干预措施: Arthroscopic acetabular labral repair (Procedure)
Arthroscopic acetabular labral resection
The acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.
干预措施: Arthroscopic acetabular labral resection (Procedure)
结局指标
主要结局
Hip Outcome Score
时间窗: 6 Months Post Intervention
Change in Hip Outcome Score (Activities of Daily Living Subscale) at 6 months post intervention from baseline.
次要结局
- Health Economics(6, 12, 18 & 24 months post intervention)
- X Ray(6 Months Post Intervention)
- Biomarkers of Osteo Arthritis (OA)(At surgery and 6, 12 & 24 months post intervention.)
- Hip Outcome Scores (HOS)(12, 18 & 24 months post intervention)
- Clinical Assessment of Function(6, 12 & 24 months post intervention.)
- Physiologic MRI(6 Months Post Intervention)