Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique (RCRPRFM)
2017年7月11日 更新者：HealthPartners Institute
Arthroscopic Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique: A Randomized Blinded Outcomes Study
This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques.
One technique used is the standard double row repairs utilizing medial and laterally based anchor fixation and the other technique is the standard double row repairs utilizing medial and laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM).
It is hypothesized that patients undergoing the surgery with the PRFM will report a higher quality of life than the patients that do not receive this treatment.
調査の概要
研究の種類
介入
入学 (実際)
97
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Minnesota
-
Bloomington、Minnesota、アメリカ、55431
- TRIA Orthopaedic Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Evidence of a rotator cuff tear as determined by clinical examination and diagnostic imaging (MRI)
- Patient undergoes arthroscopic rotator cuff repair
- Age 18 or older
Exclusion Criteria:
Pre-operative exclusion criteria
- Patient has had a previous arthroscopic rotator cut repair
- A previous diagnosis of Rheumatoid Arthritis
- Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous surgery of the affected shoulder,
- Evidence of significant rotator cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
- Medical device that would exclude the patient from having a MRI, including a pacemaker, cardiac defibrillator, aneurysm clips, carotid artery clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, or ear implant.
- Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
- Inability to speak or read English
- Psychiatric illness that precludes informed consent.
- Pregnant patients.
- Age 17 or younger
- Unwillingness to be followed for 2 years.
- Bilateral Rotator cuff tear confirmed by clinical exam and MRI
- Patients enrolled in the study who demonstrate retear on clinical exam and MRI, then elect for a repeat surgery.
Intra-operative exclusion criteria (Note: This information will be collected during the chart audit and patients will be excluded from the study at that time.)
- Irreparable cuff tears or tears extending into the subscapularis or teres minor
- Isolated teres minor or subscapularis tears.
- Inelastic and immobile tendon which cannot be advanced to articular margin
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Double Row
|
|
|
実験的：Double Row with PRFM
|
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 |
|---|---|---|
|
Return to Function
時間枠：Baseline
|
The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score.
There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module.
More patients completed a baseline measure than those that completed the entire study.
|
Baseline
|
|
Return to Function
時間枠：6 months
|
The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score.
There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module.
More patients completed a baseline measure than those that completed the entire study.
|
6 months
|
|
Return to Function
時間枠：24 months
|
Western Ontario Rotator Cuff Index
|
24 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Spraspinatus Strength Measurements
時間枠：Baseline
|
Strength of supraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
Baseline
|
|
MRI
時間枠：6 months
|
MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear. Higher grades are worse radiographic outcomes. |
6 months
|
|
Supraspinatus Strength Measurements
時間枠：6 months
|
Strength of supraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
6 months
|
|
Supraspinatus Strength Measurements
時間枠：24 months
|
Strength of supraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
24 months
|
|
Infraspinatus Strength Measurements
時間枠：Baseline
|
Strength of infraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
Baseline
|
|
Infraspinatus Strength Measurements
時間枠：6 months
|
Strength of infraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
6 months
|
|
Infraspinatus Strength Measurements
時間枠：24 months
|
Strength of infraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
24 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年7月1日
一次修了 (実際)
2015年12月1日
研究の完了 (実際)
2015年12月1日
試験登録日
最初に提出
2014年8月4日
QC基準を満たした最初の提出物
2014年10月3日
最初の投稿 (見積もり)
2014年10月6日
学習記録の更新
投稿された最後の更新 (実際)
2017年8月9日
QC基準を満たした最後の更新が送信されました
2017年7月11日
最終確認日
2015年10月1日
詳しくは
本研究に関する用語
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