Augmentation of Arthroscopic Rotator Cuff Repair With Reimplantation of Subacromial Bursa Tissue and Platelet-Rich Plasma
ΕΝΙΣΧΥΣΗ ΑΡΘΡΟΣΚΟΠΙΚΗΣ ΣΥΡΡΑΦΗΣ ΣΤΡΟΦΙΚΟΥ ΠΕΤΑΛΟΥ ΜΕ ΕΠΑΝΕΜΦΥΤΕΥΣΗ ΙΣΤΟΥ ΤΟΥ ΥΠΑΚΡΩΜΙΑΚΟΥ ΘΥΛΑΚΟΥ ΚΑΙ ΠΛΑΣΜΑΤΟΣ ΠΛΟΥΣΙΟΥ ΣΕ ΑΙΜΟΠΕΤΑΛΙΑ
The goal of this observational study is to evaluate the clinical and radiographic outcomes of the biological enhancement of the arthroscopic rotator cuff repair with stem cells from the acromial bursa and PRP in individuals who undergo arthroscopic cuff repair The main question it aims to answer is:
Do the stems cells from the acromial bursa and PRP promote healing and produce better results in arthroscopic cuff repair? Researchers will compare this population to three others the first do bnot receive any biological enchancement, the second receive only stem cells and the third receive only PRP to see if there are any differences.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: ANDRIANI ZAFEIRI, MEDICAL DOCTOR
- 전화번호: +306933398382
- 이메일: andrianizaf@hotmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria Adult patients aged ≥18 years. Patients undergoing arthroscopic rotator cuff repair. Patients with a full-thickness, isolated, primary tear of the supraspinatus tendon.
Patients considered eligible for arthroscopic rotator cuff repair using suture anchors.
Ability and willingness to provide written informed consent. Willingness and ability to comply with the study protocol and scheduled follow-up visits.
Exclusion Criteria Partial-thickness rotator cuff tears. Massive or irreparable rotator cuff tears. Revision rotator cuff repair. Concomitant tears of the subscapularis tendon, infraspinatus tendon, long head of the biceps tendon requiring surgical treatment, or glenoid labrum.
Previous surgery on the affected shoulder. Glenohumeral osteoarthritis or advanced cuff tear arthropathy. Active infection or systemic inflammatory disease affecting the shoulder. Use of other biological augmentation techniques during surgery, such as collagen patch, stem cells, bone marrow aspirate concentrate, or other scaffold-based augmentation.
Inability to provide informed consent. Inability or unwillingness to comply with the postoperative rehabilitation protocol or follow-up schedule.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: GROUP A
(MSCs + PRP): 1 ml of a mixture of subacromial bursa and 3 ml of PRP will be placed in the bone-tendon junction after completion of the arthroscopic suturing
|
Autologous minced subacromial bursal tissue harvested arthroscopically using a tissue collection device and applied at the bone-tendon interface immediately after rotator cuff repair.
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
Autologous platelet-rich plasma prepared from preoperatively collected peripheral blood and applied at the bone-tendon interface immediately after repair completion.
|
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실험적: GROUP B
1 ml of a mixture of subacromial bursal tissue fragments without PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.
|
Autologous minced subacromial bursal tissue harvested arthroscopically using a tissue collection device and applied at the bone-tendon interface immediately after rotator cuff repair.
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
|
|
실험적: GROUP C
3 ml of PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.
|
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
Autologous platelet-rich plasma prepared from preoperatively collected peripheral blood and applied at the bone-tendon interface immediately after repair completion.
|
|
위약 비교기: GROUP D
3 ml of saline will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.
|
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
Three milliliters of sterile normal saline applied at the bone-tendon interface immediately after arthroscopic rotator cuff repair as placebo comparator.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Functional Outcome Assessed by Constant-Murley Score and ASES Score
기간: The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively. Both scores are validated instruments ev
|
The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively.
Both scores are validated instruments evaluating pain, daily activities, and shoulder function, with higher scores indicating better clinical outcomes.
|
The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively. Both scores are validated instruments ev
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rotator Cuff Tendon Integrity Assessed by MRI (Sugaya Classification)
기간: 12 months postoperatively
|
Tendon integrity will be evaluated using magnetic resonance imaging (MRI) at 12 months postoperatively.
Repair integrity will be classified according to the Sugaya classification system and categorized to assess healing or re-tear.
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12 months postoperatively
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Pain Intensity Assessed by Numeric Rating Scale (NRS)
기간: 3, 6, and 12 months postoperatively
|
Postoperative pain will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 3, 6, and 12 months postoperatively.
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3, 6, and 12 months postoperatively
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Health-Related Quality of Life Assessed by SF-12
기간: 3, 6, and 12 months postoperatively
|
Quality of life will be evaluated using the 12-Item Short Form Health Survey (SF-12) at 3, 6, and 12 months postoperatively.
The questionnaire provides physical and mental health composite scores.
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3, 6, and 12 months postoperatively
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Patient Satisfaction
기간: 3, 6, and 12 months postoperatively
|
Patient satisfaction will be assessed using a Numeric Rating Scale from 0 to 10 at 3, 6, and 12 months postoperatively, with higher scores indicating greater satisfaction.
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3, 6, and 12 months postoperatively
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Postoperative Complications and Retear Rate
기간: Up to 12 months postoperatively
|
All postoperative complications and symptomatic retears will be recorded throughout the follow-up period.
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Up to 12 months postoperatively
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Andriani Zafeiri
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
PRP에 대한 임상 시험
-
Lahore General Hospital모병
-
Dr. Sirajul Islam Medical CollegeDhaka Medical College아직 모집하지 않음여드름 흉터 | 혈소판 풍부 혈장(PRP) | 절제 분획 Co fr 레이저 요법방글라데시