Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Bone tunnel volume
研究概览
简要总结
Primary objective of the study is to evaluate efficacy of the surgical technique for ACL reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon autograft, compared to the traditional technique.
详细描述
Reconstruction of the anterior cruciate ligament (ACL) using autograft tissue is currently recommended as the standard of care following an ACL tear or rupture, with the bone-tendon-bone (BTB) graft and hamstring tendon graft the most common. Although a BTB autograft is widely recognized to offer high mechanical performance and rapid graft healing, these advantages come at the cost of a longer surgery time and higher risk of severe patient discomfort at the graft harvest site. Use of a hamstring tendon autograft is less painful, but is generally slower to heal with higher risk of mechanical graft failure due to poor bone ingrowth. The aim of the current study is to augment graft-to-bone incorporation by use of an osteoconductive scaffold enlaced into the hamstring tendon autograft. This bovine derived composite bone substitute is inserted into the articular aperture of the femoral bone tunnel and should provide an osteoconductive / osteoinductive environment at a biomimetic attachment site leading to improved secondary graft-fixation and a reduced incidence of tunnel widening.
Primary objective of the study is to evaluate efficacy of the surgical technique for ACL reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon autograft, compared to the traditional technique.
Secondary objectives aim to assess the clinical outcome of the interventional treatment including patient subjective knee function and objective measures of knee stability.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute unilateral complete tear of the ACL that occurred within 18 weeks before planned surgery and requires reconstruction of the
- •Informed consent as documented by signature
排除标准
- •Prior ACL reconstruction or other surgical procedure on the affected knee.
- •Prior fracture of the affected leg.
- •Multi-ligament reconstruction.
- •Previous or current ACL injury on contra-lateral leg.
- •Medical condition or comorbidity that would interfere with study participation.
- •The patient is mentally compromised.
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- •Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc.).
研究组 & 干预措施
Control treatment
ACL-reconstruction using hamstring autograft with hybrid fixation in accordance with in-house standard of care.
干预措施: Hamstring tendon-only repair (Device)
Experimental treatment
ACL-reconstruction using hamstring autograft with hybrid fixation combined with the osteoconductive device under study.
干预措施: Osteoconductive scaffold-hamstring tendon composite repair (Device)
结局指标
主要结局
Bone tunnel volume
时间窗: 0, 4.5, 12 months post surgery
CT based relative change of the femoral bone tunnel volume from baseline to follow-up 1 and 2.
次要结局
- Pivot shift test(0 and 42 days, 6 months, 1, 2 and 5 years post surgery)
- Tegner Activity Scale(0 and 42 days, 6 months, 1, 2 and 5 years post surgery)
- IKDC Subjective Knee Evaluation Form(0 and 42 days, 6 months, 1, 2 and 5 years post surgery)
- KT-1000 Arthrometer Test(0 and 42 days, 6 months, 1, 2 and 5 years post surgery)
- Lachmann Test(0 and 42 days, 6 months, 1, 2 and 5 years post surgery)
- Osteoconductive scaffold-bone integration(day 0, 4.5 and 12 months post surgery)
- Lysholm Knee Scoring Scale(0 and 42 days, 6 months, 1, 2 and 5 years post surgery)
- Bone tunnel width(0 and 42 days, 12 and 24 months post surgery)
研究者
Sandro Fucentese
Head of Knee Surgery
Balgrist University Hospital