Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique (RCRPRFM)
2017년 7월 11일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
97
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Minnesota
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Bloomington, Minnesota, 미국, 55431
- TRIA Orthopaedic Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Double Row
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실험적: Double Row with PRFM
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Return to Function
기간: Baseline
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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.
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Baseline
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Return to Function
기간: 6 months
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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.
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6 months
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Return to Function
기간: 24 months
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Western Ontario Rotator Cuff Index
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24 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Spraspinatus Strength Measurements
기간: Baseline
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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.
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Baseline
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MRI
기간: 6 months
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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
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Supraspinatus Strength Measurements
기간: 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.
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6 months
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Supraspinatus Strength Measurements
기간: 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.
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24 months
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Infraspinatus Strength Measurements
기간: Baseline
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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.
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Baseline
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Infraspinatus Strength Measurements
기간: 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
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Infraspinatus Strength Measurements
기간: 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.
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24 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 7월 1일
기본 완료 (실제)
2015년 12월 1일
연구 완료 (실제)
2015년 12월 1일
연구 등록 날짜
최초 제출
2014년 8월 4일
QC 기준을 충족하는 최초 제출
2014년 10월 3일
처음 게시됨 (추정)
2014년 10월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 8월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 7월 11일
마지막으로 확인됨
2015년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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