Autologous Semitendinosus Tendon Graft as Meniscal Transplant - a Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Failure
研究概览
简要总结
Removal of meniscal tissue is described to result in poor knee function and a significant risk for future development of osteoarthritis. Different implants have been suggested to substitute a removed meniscus. Meniscal allograft transplantation is not widely available due to costs and availability. The semitendinosus tendon is a known graft with biological properties with potential to remodel and revascularize in an intraarticular environment such as anterior cruciate ligament reconstruction. The objective for this study was to investigate whether the semitendinosus tendon graft could function as a meniscal transplant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous subtotal or total meniscectomy
- •Post meniscectomy symptoms
- •No osteoarthritic changes on radiography more than Ahlbäck 1
- •Knee aligment (hip-knee-angle) +/- 3°
- •No persisting ACL insufficiency
排除标准
- •Difficulty understanding the instructions
- •Current psychiatric diagnosis
结局指标
主要结局
Failure
时间窗: 2 years
Surgical failure of transplant defined as meniscus symptoms (joint line tenderness, swelling, locking or positive McMurray) resulting in a need for re-arthroscopy and subtotal or total resection of the transplant.
次要结局
- Improved subjective knee function(2 years)
研究者
Karl O. Eriksson
Associate Professor
Karolinska Institutet