- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07671729
Quadriceps Tendon vs Peroneus Longus Tendon in ACL Reconstruction
A Prospective Randomized Clinical Trial Comparing Quadriceps Tendon and Peroneus Longus Tendon Autografts in Anterior Cruciate Ligament Reconstruction: Clinical, Functional, and Gait Analysis Outcomes
연구 개요
상태
상세 설명
Anterior cruciate ligament (ACL) reconstruction is one of the most commonly performed orthopedic procedures for restoring knee stability and enabling return to sports activities after ACL injury. Various autograft options have been described for ACL reconstruction, including hamstring tendon, bone-patellar tendon-bone, quadriceps tendon, and more recently, peroneus longus tendon grafts. Each graft option has unique biomechanical characteristics, advantages, and potential donor site morbidities.
Quadriceps tendon autografts have gained increasing popularity because of their adequate graft diameter, favorable biomechanical properties, and relatively low donor site complications. Peroneus longus tendon autografts have also emerged as a promising alternative graft source with satisfactory clinical outcomes and sufficient graft size. However, concerns remain regarding donor site morbidity, particularly potential effects on ankle muscle strength and ankle function following peroneus longus tendon harvesting.
This prospective randomized study aims to compare quadriceps tendon and peroneus longus tendon autografts in patients undergoing primary ACL reconstruction. Patients will be randomly assigned into two groups according to graft type. Clinical evaluations, functional knee scores, return-to-sport outcomes, ankle muscle strength assessments, ankle-related functional scores, and gait analysis parameters will be assessed during postoperative follow-up.
Follow-up evaluations will be performed at 6 months and 12 months after surgery. The findings of this study are expected to contribute to graft selection strategies in ACL reconstruction by providing comparative data regarding clinical outcomes, functional recovery, gait characteristics, and donor site morbidity.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Besiktas
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Istanbul, Besiktas, 터키 (Türkiye), 34349
- 모병
- Acibadem Fulya Hospital, Sport Medicine Center
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연락하다:
- Tunay Erden, M.D.
- 전화번호: +905546289045
- 이메일: tunayerden@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients diagnosed with anterior cruciate ligament rupture
- Patients scheduled for primary anterior cruciate ligament reconstruction
- Age between 18 and 50 years
- Ability to provide informed consent
- Willingness to comply with postoperative rehabilitation and follow-up evaluations
Exclusion Criteria:
- Previous ligament reconstruction surgery on the affected knee
- Multi-ligament knee injuries requiring additional ligament reconstruction
- Severe osteoarthritis of the knee
- Revision anterior cruciate ligament reconstruction
- Neuromuscular disorders affecting lower extremity function
- Active infection
- Inability to comply with follow-up protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Quadriceps Tendon Autograft
Patients undergoing anterior cruciate ligament reconstruction using quadriceps tendon autograft.
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Anterior cruciate ligament reconstruction performed using quadriceps tendon autograft.
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실험적: Peroneus Longus Tendon Autograft
Patients undergoing anterior cruciate ligament reconstruction using peroneus longus tendon autograft.
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Anterior cruciate ligament reconstruction performed using peroneus longus tendon autograft.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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International Knee Documentation Committee (IKDC) Subjective Knee Score
기간: 12 months postoperatively
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Comparison of postoperative subjective knee function between quadriceps tendon and peroneus longus tendon autograft groups using the International Knee Documentation Committee (IKDC) subjective knee evaluation form.
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12 months postoperatively
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Return to Sport Rate
기간: Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.
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6 and 12 months postoperatively
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Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.
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Ankle Plantar Flexion Strength
기간: 6 and 12 months postoperatively
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Isokinetic ankle plantar flexion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during plantar flexion will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ankle Dorsiflexion Strength
기간: 6 and 12 months postoperatively
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Isokinetic ankle dorsiflexion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during dorsiflexion will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ankle Inversion Strength
기간: 6 and 12 months postoperatively
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Isokinetic ankle inversion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during inversion will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ankle Eversion Strength
기간: 6 and 12 months postoperatively
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Isokinetic ankle eversion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during eversion will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ankle Rotational Strength
기간: 6 and 12 months postoperatively
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Isokinetic ankle rotational strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during rotational movements will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ground Reaction Force
기간: 6 and 12 months postoperatively
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Lower extremity biomechanical performance will be assessed using the VALD ForceDecks dual force plate system.
Ground reaction force (N) during standardized standing and functional testing tasks will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Force Asymmetry
기간: 6 and 12 months postoperatively
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Lower extremity biomechanical performance will be assessed using the VALD ForceDecks dual force plate system.
Force asymmetry (%) during standardized standing and functional testing tasks will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Weight Distribution
기간: 6 and 12 months postoperatively
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Lower extremity biomechanical performance will be assessed using the VALD ForceDecks dual force plate system.
Weight distribution (%) during standardized standing and functional testing tasks will be recorded and compared between study groups.
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6 and 12 months postoperatively
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 연구와 관련된 용어
키워드
기타 연구 ID 번호
- Quadriceps vs PL
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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