The Contribution of Platelet-Rich Plasma to the Surgical Treatment of Rotator Cuff Tear: An Experimental Study
Purpose of the study:
The aim of the study is to determine whether the postoperative administration of biological therapy with autologous platelet-rich plasma improves the clinical, imaging, and biochemical outcomes following surgical repair of a shoulder rotator cuff tear.
What does the study involve? The study involves the postoperative administration of biological therapy after blood is drawn from the patients and processed appropriately. All patients will also undergo the necessary laboratory and imaging preoperative assessments, the surgical procedure, and standard postoperative rehabilitation, as routinely performed at this center. Tissue samples may be collected intraoperatively for testing. Postoperative follow-up will include clinical evaluations at specific time points-before surgery and at 1 month (regarding pain), 3 months, 6 months, and 1 year after therapy administration. At 6 months post-treatment, patients will undergo a follow-up MRI scan.
調査の概要
状態
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Attica
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Kifissia、Attica、ギリシャ、14561
- KAT General Hospital
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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:
The patients enrolled had symptomatic rotator cuff tears, which were confirmed by magnetic resonance imaging (MRI). They had failed previous conservative management and physical therapy of at least 3 months and were candidates for surgical treatment.
Exclusion Criteria:
a) acute shoulder trauma, (b) any history of a previous surgical operation on their shoulder, (c) the local administration of corticosteroids up to fifteen days before the operation or systemic administration of corticosteroids up to a month before the operation, (d) the use of non-steroidal anti-inflammatory drugs during the trial, (e) any signs of infection or systematic inflammatory disease for at least fifteen days before the operation, (f) history of malignancy or chemotherapy during the previous year, (g) rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head, (h) pregnancy or breastfeeding, and in case of any of these conditions the patients where ultimately excluded from the trial results.
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：独身
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：PRP Treatment Group
The patients underwent arthroscopic repair of rotator cuff tear.
They were administered a single intraarticular PRP injection in the operated shoulder at 10-15 days postoperatively.
The postoperative protocol included using a shoulder sling with no active range of motion for four weeks, followed by a rehabilitation program of progressive active-assisted, active range of motion (ROM) and muscle strengthening for two months.
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All patients received general anesthesia and were operated on in the "beach chair" position.
Concerning the arthroscopic rotator cuff repair, systematic glenohumeral joint and subacromial exploration were performed, and lesions were managed as necessary.
In each case, after the frayed and atrophied torn end was removed, the rotator cuff tear was carefully evaluated, and anteroposterior size, mediolateral retraction, number of involved tendons, visual tendon grade, excursion, and presence of the subscapularis tear were assessed.
Debridement of bursal tissue and subacromial and distal clavicle osteophytes was minimally performed.
Extensive acromioplasty to flatten a hooked or curved acromion was rarely performed.
Rotator cuff repair was performed to cover the original footprint using suture anchors that were inserted through the accessory portal.
The patients of both groups followed the same postoperative rehabilitation protocol.
The patients of treatment goup were administered a single intraarticular PRP injection in the operated shoulder at 10-15 days postoperatively.
An autologous sample of 9 ml of peripheral blood was collected, and after addition of anticoagulant and preparation with a centrifuge for 6 minutes, 4ml of PRP was received and injected intraarticularly in a subacromial fashion.
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アクティブコンパレータ：Control group
The patients underwent arthroscopic repair of rotator cuff tear.
They did not receive any shoulder injection postoperatively.
The postoperative protocol included using a shoulder sling with no active range of motion for four weeks, followed by a rehabilitation program of progressive active-assisted, active range of motion (ROM) and muscle strengthening for two months.
|
All patients received general anesthesia and were operated on in the "beach chair" position.
Concerning the arthroscopic rotator cuff repair, systematic glenohumeral joint and subacromial exploration were performed, and lesions were managed as necessary.
In each case, after the frayed and atrophied torn end was removed, the rotator cuff tear was carefully evaluated, and anteroposterior size, mediolateral retraction, number of involved tendons, visual tendon grade, excursion, and presence of the subscapularis tear were assessed.
Debridement of bursal tissue and subacromial and distal clavicle osteophytes was minimally performed.
Extensive acromioplasty to flatten a hooked or curved acromion was rarely performed.
Rotator cuff repair was performed to cover the original footprint using suture anchors that were inserted through the accessory portal.
The patients of both groups followed the same postoperative rehabilitation protocol.
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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 |
時間枠 |
|---|---|
|
Change from baseline of Constant - Murley score
時間枠：at 3, 6 and 12 months postoperatively
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at 3, 6 and 12 months postoperatively
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Change from baseline of ASES score
時間枠：at 3, 6 and 12 months postoperatively
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at 3, 6 and 12 months postoperatively
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Rate of shoulder rotator cuff tendon retears
時間枠：at 6 months postoperatively
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at 6 months postoperatively
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Measurement of pain on a Numerical Rating Scale (NRS) of 0 to 15
時間枠：at 1 month postoperatively
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at 1 month postoperatively
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 18/08-06-2021
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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