Labral Repair vs Reconstruction
Labral Repair Versus Reconstruction in Symptomatic Femoroacetabular Impingement in Patients Over 40 Years of Age - A Randomized Controlled Trial
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
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London、Ontario、カナダ、N6A 3K7
- Fowler Kennedy Sport Medicine Clinic
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コンタクト:
- Ashley Ambrose
- 電話番号:87528 5196612111
- メール:ashley.ambrose@lhsc.on.ca
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主任研究者:
- Ryan Degen
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ:Labral Repair
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
|
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
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アクティブコンパレータ: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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この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
International Hip Outcome Tool (iHOT) - 12
時間枠:Baseline to 2 years post surgical follow-up
|
Baseline to 2 years post surgical follow-up
|
二次結果の測定
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Hip Outcome Score- Activities of Daily Living (HOS-ADL)
時間枠:Baseline to 2 years post surgical follow-up
|
Baseline to 2 years post surgical follow-up
|
|
Hip Outcome Score- Sport Specific Subscale (HOS-SSS)
時間枠:Baseline to 2 years post surgical follow-up
|
Baseline to 2 years post surgical follow-up
|
|
modified Harris Hip Score (mHHS)
時間枠:Baseline to 2 years post surgical follow-up
|
Baseline to 2 years post surgical follow-up
|
|
EQ-5D
時間枠:Baseline to 2 years post surgical follow-up
|
Baseline to 2 years post surgical follow-up
|
|
Cost Diary
時間枠:6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
|
|
Patient Satisfaction Scale
時間枠:6 weeks to 2 years post surgical follow-up
|
6 weeks to 2 years post surgical follow-up
|
|
Post-operative complication rates
時間枠:6 weeks to 2 years post surgical follow-up
|
6 weeks to 2 years post surgical follow-up
|
|
Subsequent surgery rates
時間枠:6 weeks to 2 years post surgical follow-up
|
6 weeks to 2 years post surgical follow-up
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 127777
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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