Labral Repair vs Reconstruction
Labral Repair Versus Reconstruction in Symptomatic Femoroacetabular Impingement in Patients Over 40 Years of Age - A Randomized Controlled Trial
研究概览
详细说明
Femoroacetabular impingement syndrome (FAIS) is an increasingly common cause hip pain. It is known to cause labral pathology and if left untreated, can also contribute to the development of hip osteoarthritis. While non-operative treatment has been shown to be effective and can improve patients' quality of life, surgical treatment has often been shown to yield superior outcomes, while also potentially decreasing the future risk of osteoarthritis.
Mid- to long-term outcomes have shown durable results following hip arthroscopy with significant improvements in patient reported outcome measures (PROMs). Consequently, hip arthroscopy utilization has continued to increase. Several retrospective cohort studies have attempted to identify prognostic variables associated with procedural outcomes. In terms of patient selection, age has historically been identified as a negative prognostic variable, with inferior clinical outcomes observed in patients over the age of 40. However, more recent studies have disputed this finding, suggesting that earlier studies reporting this included patients with concomitant hip osteoarthritis, which was more to blame than their chronological age. Recent case series have reported significant improvements in PROMs in patients over the age of 40 who have minimal concomitant OA (Tönnis 0 or 1), with durable results out to 5 years14-16.
Despite these encouraging results, newer concerns have been raised when it comes to labral treatment in this demographic. It has been suggested that in patients over 40 years of age, the labrum may be too traumatized to allow repair or that it may have diminished healing capacity from repetitive impingement or age-related degeneration. As such, there have been proponents of performing a primary labral reconstruction in this patient population, with better associated outcomes. Others have reported equivocal outcomes between repair and reconstruction for this group. As such, there is no consensus on the best treatment strategy to manage these patients.
The results of this pilot study will allow the investigators to determine whether a full-scale study will be feasible. The investigators will not move forward with the full study: 1) if the proportion of eligible patients providing consent is <80%; 2) If the 95% confidence intervals around the difference between groups does not include even the possibility of a small, but important effect (0.2 SD); 3) if the proportion of patients completing their one-year follow-up is <85%, then the study is not feasible.
Ultimately, for the full-scale study, the investigators hypothesize that patients treated with labral reconstruction will have significantly better outcome scores compared with patients who underwent a traditional labral repair. If the hypothesized findings are true in the full study, this will change clinical practice patterns by providing objective evidence to guide treatment of labral pathology in patients over the age of 40 undergoing hip arthroscopy for FAIS.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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London、Ontario、加拿大、N6A 3K7
- Fowler Kennedy Sport Medicine Clinic
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接触:
- Ashley Ambrose
- 电话号码:87528 5196612111
- 邮箱:ashley.ambrose@lhsc.on.ca
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首席研究员:
- Ryan Degen
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion:
-Cam or pincer morphology who have failed a trial of conservative treatment
Exclusion:
- Moderate concomitant OA (Tönnis 2+)
- Have had previous hip surgery
- Active joint or systemic infection
- Significant muscle paralysis
- Inflammatory arthropathies
- Significant medical comorbidity that may alter effectiveness of surgical intervention
- Active smoker
- Major medical illness
- Unable to speak and understand English
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for 2 years
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Labral Repair
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
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Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
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有源比较器:Labral Reconstruction
Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
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Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
International Hip Outcome Tool (iHOT) - 12
大体时间:Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Hip Outcome Score- Activities of Daily Living (HOS-ADL)
大体时间:Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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Hip Outcome Score- Sport Specific Subscale (HOS-SSS)
大体时间:Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
|
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modified Harris Hip Score (mHHS)
大体时间:Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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EQ-5D
大体时间:Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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Cost Diary
大体时间:6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Patient Satisfaction Scale
大体时间:6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Post-operative complication rates
大体时间:6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Subsequent surgery rates
大体时间:6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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