Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps Tendon Autograft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Lysholm knee score
研究概览
简要总结
The use of hamstrings and quadriceps autografts as an alternative option for reconstruction of the anterior cruciate ligament has good clinical results: however, both techniques have not been compared among them, which is why this study is intended. The use of quadriceps tendon autograft in anterior cruciate ligament repair presents similar or better results compared to autograft of the hamstrings. The objective of the study is to compare the clinical effectiveness of anterior cruciate ligament reconstruction between the use of quadriceps tendon autograft versus hamstring autograft.
详细描述
Methods Institution Patients attending the Orthopedics and Traumatology consult of the Hospital Universitario "Dr. Jose Eleuterio Gonzalez" of the Universidad Autonoma de Nuevo Leon.
Study design This is a double-blind , prospective, reproducible, comparative and longitudinal clinical trial with specific population.
It is proposed to study 28 patients, being randomly divided into two groups. Inclusion criteria: patients of age between 18 years and 45 years, with anterior cruciate ligament (ACL) injury diagnosed clinically and by magnetic resonance image and with or without associated meniscal injury, without previous reconstruction surgery and with previous informed Consent.
Exclusion criteria: multiligamentous injury and/or diagnosis of moderate or severe ostearthritis, chronic degenerative diseases (diabetes mellitus, hypertension) and contralateral ACL injury.
Elimination criteria: own initiative to stop participating and those who didn't complete all follow-up appointments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years and 45 years
- •Anterior cruciate ligament injury diagnosed clinically and by image (magnetic resonance)
- •Patients with or without associated meniscal injury
- •Patients without previous ACL reconstruction surgery
- •Patients with previous informed Consent.
排除标准
- •Patients with multiligamentous injury
- •Patients who have diagnosis of moderate or severe ostearthritis
- •Patients with chronic degenerative diseases (diabetes mellitus, hypertension)
- •Patients with contralateral ACL injury.
- •Elimination criteria
- •Patients that for own initiative, wants to stop participating
- •Patients who didn't complete all follow-up appointments.
研究组 & 干预措施
Hamstring
It is the group in which the hamstrings are surgically removed to be used as an autograft for the reconstruction of the anterior cruciate ligament. The intervention will consist of make an incision on the medial side of the proximal portion of the leg approximately 3 centimeters to dissect by planes until the tendons of the hamstrings are located, which will be removed surgically with specialized instruments and the wound will be closed, for later These tendons be used as an autograft for the reconstruction of the anterior cruciate ligament.
干预措施: Hamstring (Procedure)
Quadriceps tendon
It is the group in which a portion of the quadriceps tendon will be surgically removed for later use as an autograft for the reconstruction of the anterior cruciate ligament. The intervention consisted in making an incision in the anterior aspect of the distal portion of the thigh of approximately 3 centimeters to dissect by planes until locating the membranous portion of the quadriceps tendon, from which will be removed a portion of surgical way with specialized instruments and the Wound will be closed, for later this tendon to be used as an autograft for the reconstruction of the anterior cruciate ligament.
干预措施: Quadriceps tendon (Procedure)
结局指标
主要结局
Lysholm knee score
时间窗: up to 12 months (Baseline and 12 months)
Assessment tool for the results of ACL reconstruction even though it only measures activities of daily living. Higher scores indicate a better outcome with fewer symptoms or disability.
次要结局
- Flexion (degrees)(up to 12 months (Baseline and 12 months))
- Extension (degrees)(up to 12 months (Baseline and 12 months))
- Thigh circumference (cm)(up to 12 months (Baseline and 12 months))
- IKDC subjective score(up to 12 months (Baseline and 12 months))
- SF-12 mental domain(up to 12 months (Baseline and 12 months))
- SF-12 physical domain(up to 12 months (Baseline and 12 months))
研究者
FELIX VILCHEZ CAVAZOS
Professor of Orthopedics and Traumatology
Universidad Autonoma de Nuevo Leon