Synthetic Bone Graft Substitute (Actifuse) vs. Autologous Spongiosa for Tunnel Enlargement in Revision Anterior Cruciate Ligament Reconstruction - a Histological and Radiological Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- histological assessment of bony consolidation
研究概览
简要总结
The overall objective is the histological and radiological assessment of bony consolidation of the tibial/femoral tunnel using either bone graft substitute (Actifuse) or autologous spongiosa in patients undergoing revision anterior cruciate ligament reconstruction.
Clinical correlation with the histological and radiological results using the SF36 questionnaire.
详细描述
* Study design: Monocentric, prospective, randomised study. Patients who need revision anterior cruciate ligament reconstruction and show a tunnel enlargement of >10mm will have a first operation filling the tibial/femoral tunnel either with bone graft substitute (Actifuse) or autologous spongiosa.
5 - 6 months after this first operation a CT will be performed to assess the bony consolidation of the former tibial/femoral tunnel. An MRI will be performed to assess vitality of the bone substitute.
An osseous biopsy will be taken from the tibial/femoral tunnel at the revision anterior cruciate ligament reconstruction approximately 6 months after bone grafting.
Clinical evaluation will be performed 6 weeks, 3 months and 6 months postoperative. At 6 months postoperative additional radiological evaluation and clinical assessment using the SF36 questionnaire will be performed.
- Treatment: Either autologous spongiosa or Actifuse (MIS applicator) will be administered by the investigator as a bone graft substitute for tunnel enlargement in patients undergoing revision anterior cruciate ligament reconstruction.
- Duration of Participation: The participation of each subject will be approximately 12 months.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in need of revision anterior cruciate ligament reconstruction
排除标准
- •Infection, wound healing complications
研究组 & 干预措施
Actifuse
Actifuse to fill bone tunnel
干预措施: Actifuse (Procedure)
bone graft
bone graft to fill bone tunnel
干预措施: bone graft (Procedure)
结局指标
主要结局
histological assessment of bony consolidation
时间窗: 6 months postop
histological probes during second intervention to measure bony ingrowth into bone substitute material
次要结局
- IKDC Score(3, 6 and 12 Months)
- stability measurement using KT1000(3, 6 and 12 Months)
- SF36-Score(3, 6 and 12 Months)
- Tegner Activity Score(3, 6 and 12 Months)
研究者
Jan von Recum
Dr. med.
Berufsgenossenschaftliche Unfallklinik Ludwigshafen