“A randomized controlled study assessing outcomes after anterior cruciate ligament reconstruction, using quadriceps tendon autograft and hamstrings tendon autograft at the end of one year.â€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- measurement of the one leg hop index after quadriceps tendon(QT) autograft and hamstrings tendon autograft for ACLR at the end of one year.
研究概览
简要总结
This study is a randomized, double blind, parallel group, trail comparing the safety and efficacy of quadriceps tendon autograft and Hamstrings tendons autograft for anterior cruciate ligamnent insuffieciency. The study will be conducted at Jawaharlal institute of postgraduate medical education and research puducherry on 60 patients meeting the inclusion and exclusion criteria. The primary outcome measures will be measurement of one leg hop index at the end of one year after the anterior cruciate ligament reconsctrution with either of the grafts. The secondary outcomes will be measurement of international knee documentation committee (IKDC) subjective and objective assessments at the end of one.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with complete/partial ACL rupture with or without concomitant grade I and Grade II injuries to the collateral ligaments requiring surgery due to instability.
排除标准
- •1 Patients presenting with an ACL injury greater than one year will be excluded from the study.
- •2 Patients with avulsion fractures will be excluded from the study.
- •3 Inability to give informed consent for the study.
- •5 Current or past injuries to the ipsi- or contralateral knee, possibly altering knee function, including previous ACL rupture.
- •6 Patients with a concomitant posterior cruciate ligament injury 7 Concomitant articular cartilage lesions larger than 2 cm with a depth of more than 50%of the cartilage thickness; and meniscal injuries involving more than two-thirds of the meniscus or the need for meniscus repair.
- •8 Mal-alignment of the lower extremity (greater than 5 mm of mechanical axis deviation as measured on standing hip-knee-ankle radiographs).
结局指标
主要结局
measurement of the one leg hop index after quadriceps tendon(QT) autograft and hamstrings tendon autograft for ACLR at the end of one year.
时间窗: one year after operation.
次要结局
- measurement of the functional outcomes using subjective international knee documentation committee( IKDC) form.(one year after operation)