Comparison of functional and radiological outcomes of bioscrew vs loop washer for tibial site fixation in arthroscopic anterior cruciate ligament reconstruction using peroneus longus autograft.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- We would be able to compare the functional and radiological outcomes of bioscrew versus loop washer for tibial site fixation of peroneus longus graft in patients undergoing arthroscopic ACL reconstruction using validated scoring systems such as the IKDC (International Knee Documentation Committee) score, Tegner and Lysholm Knee Score and radiological outcomes using MRI.
研究概览
简要总结
This thesis titled “A Comparative Study Between Bioscrew and Loop Washer for Tibial Site Fixation in Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Using Peroneus Longus Autograft” aims to evaluate two widely used fixation methods for ACL reconstruction. ACL injuries are common among young active individuals, and tibial fixation plays a critical role in ensuring graft stability and successful outcomes. While bioscrews are traditionally preferred for their direct compression and ease of use, loop washers offer suspensory fixation with potential benefits such as reduced tunnel widening and better graft integration.
This study is designed as a prospective, randomized cohort trial involving 64 patients aged 18–40 years, who will undergo ACL reconstruction with peroneus longus autograft at AIIMS Gorakhpur. Patients will be randomized into two groups: Group A (bioscrew fixation) and Group B (loop washer fixation). Outcomes will be assessed using validated functional scores (IKDC, Lysholm, Tegner) and radiological evaluation by MRI at 6 and 12 months. Secondary outcomes include complication rates, graft incorporation, patient satisfaction, and return to activity.
The study hypothesizes that both fixation methods provide comparable functional and radiological outcomes. Findings are expected to bridge the current evidence gap regarding tibial fixation with peroneus longus grafts and may guide future surgical decision-making for improved patient outcomes in ACL reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 40 years undergoing primary arthroscopic anterior cruciate ligament reconstruction.
- •No previous history of injury or surgery in the knee and normal contralateral knee.
- •No concomitant injury to lateral collateral ligament, medial collateral ligament or posterior cruciate ligament.
- •No systemic disease or illness that may affect the surgery.
排除标准
- •Revision anterior cruciate ligament surgery.
- •Concomitant ligament injuries requiring repair.
- •Severe chondral damage (Outerbridge grade III/IV)
- •History of knee infection or systemic inflammatory disease
- •Patient who refuses to give consent.
结局指标
主要结局
We would be able to compare the functional and radiological outcomes of bioscrew versus loop washer for tibial site fixation of peroneus longus graft in patients undergoing arthroscopic ACL reconstruction using validated scoring systems such as the IKDC (International Knee Documentation Committee) score, Tegner and Lysholm Knee Score and radiological outcomes using MRI.
时间窗: All patient enrolling in the study will be periodically assessed by various internationally accepted knee scoring systems and using MRI at various predefined intervals – | 1) Post operative period during hospital stay | 2) At 2 weeks when sutures will be removed | 3) At 3 months | 4) At 6 months | 5) At 12 months
次要结局
- We would be able to assess complication rates (e.g., graft failure, tunnel widening, hardware irritation, infection) between bioscrew & loop washer fixation.(1) Post operative period during hospital stay)
- We would be able to determine patient satisfaction & return-to-activity levels following each fixation method.(1) Post operative period during hospital stay)
- We would be able to evaluate & compare the radiological evidence of graft integration using MRI during the follow up at 6 months & 1 year.
研究者
Dr Koustav Roy
All India Institute of Medical Sciences, Gorakhpur