NCT00364897撤回不适用
Comparison Between Two Tibial Fixation Techniques in ACL Reconstruction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 140
研究概览
简要总结
Tibial fixation is the weak link when using soft tissue grafts and interference screws for fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of patients undergoing double loop hamstring autograft ACL reconstruction and compare between the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between ages 21 and 40 years.
- •Primary ACL tears.
- •Signed Informed consent.
- •Availability during follow up period.
排除标准
- •Additional meniscal injury requiring suture.
- •Articular cartilage injury requiring surgical management.
- •Concomitant ligament injuries to the same knee requiring surgery.
- •Bilateral ACL injury.
- •Revision ACL surgery.
- •Concurrent fractures of the lower limbs caused by the same accident.
- •Post operative wound infection.
- •Post operative nerve injury
- •Cardiovascular compromise.
- •Professional sports people.
- •Soldiers on active military service.
- •Patients actively seeking compensation for injury.
- •Patients on other research protocols.
- •Patients receiving medications which alter bone metabolism: corticosteriods, Calcitonin, Flourides, Biphosphonates, Vitamin D and its derivatives, Cytotoxic drugs.
- •Non compliance. • Pregnancy
研究者
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