The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair
Effects of Platelet-Rich Fibrin Matrix on Repair Integrity of At-Risk Rotator Cuff Tears
연구 개요
상태
정황
상세 설명
Increased age, larger tear size, and more advanced fatty degeneration of the rotator cuff musculature have been correlated with poorer healing rates after rotator cuff repair. Platelets are an endogenous source of growth factors present during rotator cuff healing.
The investigators hypothesis is that augmentation of rotator cuff repairs with platelet-rich fibrin matrix (PRFM) may improve the biology of rotator cuff healing and thus improve functional outcome scores and retear rates after repair.
Rotator cuff tears at risk for retear were prospectively identified using an algorithm; points were assigned for age (50-59 years = 1; 60-69 years = 2; .70 years = 3), anterior-to-posterior tear size (2-2.9 cm = 0; 3-3.9 cm = 1; .4 cm = 2), and fatty atrophy (Goutallier score 0-2 = 0; Goutallier score 3-4 = 1). Three points were required for enrollment. Arthroscopic rotator cuff repair was performed with the addition of PRFM. Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores were obtained. Imaging and functional outcomes were compared with historical controls meeting the same enrollment criteria.
Enrollment for the study began in September 2008 and continued until March 2010.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Utah
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Salt Lake city, Utah, 미국, 84108
- University Of Utah Orthopedics Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Algorithm score greater and equal to 3
- Both men and women over the age of 50
- Full-thickness rotator cuff tear at least 2 cm in size
- Tear repairable by arthoscopic-only techniques
Exclusion Criteria:
- Inflamation joint disease
- Active use of oral steroids
- Irreparable rotator cuff tear
- Subscapularis tear requiring open repair
- Claustrophobia
- Prior rotator cuff sugery on the affected shoulder
- Failure to return for follow-up magnetic resonance imaging scan
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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PRFM Group
Patients were selected prospectively for the study based on a 3-part algorithm used to identify rotator cuff tears at risk for retear.
A total algorithm score of 3 or greater was required for enrollment in the study.
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Control Group
The control group were recruited retrospectively.
Patients who have undergone arthroscopic repair of rotator cuff tears with similar size characteristics without PRFM augmentation will be encouraged to participate by letter initially, and then by telephone invitation.
The same inclusion and exclusion criteria applied.
MRI, pain, and functional scores will be collected in the same manner as the PRFM group at one time point at least one year post operatively.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores
기간: 1 year
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Patients with symptomatic rotator cuff tears identified by clinical exam and MRI that measure greater than two centimeters or are retracted medially to the level of the humeral head cartilage.
Shoulder pain scores, functional scores, and MRI data will be obtained pre-operatively and compared to the same data collected 1 year post-operatively.
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robert Burks, MD, University Of Utah Orthopedics Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
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