Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon
Use of Long Head of bíceps Brachii Tendon as an Augmentation for Supraspinatus Tears: a Comparative Clinical Trial.
The goal of this clinical trial is to reduce the risk for re-tear in rotator cuff surgeries and improve clinical results in a working age population. The main questions it aims to answer are:
If we can improve surgical results using the long head of the biceps tendon as a graft.
If we can reduce the risk of re-tear using the long head of the biceps tendon as a graft.
Researchers will compare participants with rotator cuff tears with two different surgical techniques to see if their clinical results improve using the long head of the biceps tendon as a graft compared with not using a graft.
Participants will be asked to get enrolled in the study not knowing in which group they will be assigned to by signing a Informed Consent Form and both groups would have the same follow up conditions and treatment.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
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 Criteria:
- Active workers.
- A supraspinatus tear diagnosed in MRI.
- Modified Rohi equal or over 5 points.
- Failed conservative treatment (at least 3 months of phisiotherapy) or surgical indication secondary to acute traumatic tear with severe functional limitation.
- Age between 18 and 65.
- Long head of the biceps tendon pathology.
- Able to understand and sign the Informed Consent Form.
Exclusion Criteria:
- Tear of the subscapularis or infraspinatus tendon.
- Supraspinatus tears <1cm.
- Lack of long head of the biceps tendon.
- Rotator Cuff Arthropathy (Hamada >3).
- Glenohumeral osteoarthritis.
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Rotator Cuff Tear Augmented with Long head of the Biceps Tendon
After the supraspinsatus tendon repair, a piece of the tenotomized long head of the biceps tendon will be obtained and it will be prepared using a device to obtain a plain rectangular shaped graft that will be used to augment the supraspinatus.
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After conventional arthroscopic repair of the supraspinsatus with a double row technique, an autologous graft obtained from the long head of the biceps will be used as a Graf to improve biological properties of the supraspinatus tear; aiming to reduce re-tears and to improve Clinical results.
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アクティブコンパレータ：Rotator Cuff Tear Without Augmentation
After the supraspinatus repair, a piece of the tenotomized long head of the biceps will be obtained but not used as a graft.
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A double row technique will be performed arthroscopically.
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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
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Constant Murley Score
時間枠：From enrollment to the end of follow up at 1 year after surgery
|
Shoulder specific clinical Score
|
From enrollment to the end of follow up at 1 year after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ASES score
時間枠：From enrollment to 1 year after surgery
|
American Shoulder and Elbow Score
|
From enrollment to 1 year after surgery
|
|
VAS
時間枠：From enrollment to 1 year after surgery
|
Pain scale
|
From enrollment to 1 year after surgery
|
|
Range of Motion
時間枠：From enrollment to 1 year after surgery
|
Motion
|
From enrollment to 1 year after surgery
|
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Strenght in abduction
時間枠：From enrollment to 1 year after surgery
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From enrollment to 1 year after surgery
|
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Re-tear rate
時間枠：From enrollment to 1 year after surgery
|
From enrollment to 1 year after surgery
|
|
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Satisfaction index
時間枠：From enrollment to 1 year after surgery
|
PASS score
|
From enrollment to 1 year after surgery
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Time to return to work
時間枠：From enrollment to 1 year after surgery
|
From enrollment to 1 year after surgery
|
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)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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
- 23/654-E_Tesis
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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