Safety and Early Clinical Performance of High-Purity Type I Collagen Augmentation in Arthroscopic Meniscal Repair: A Prospective Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
研究概览
简要总结
This prospective, single-arm feasibility study evaluates the safety, procedural feasibility, and early clinical outcomes of High-Purity Type I Collagen used as an adjunct in arthroscopic meniscal repair. The study aims to generate preliminary clinical, functional, and imaging data to inform the design of a future randomized controlled trial.
详细描述
Meniscal preservation is critical for long-term knee joint health, yet healing failure remains a concern, particularly in avascular zones. High-Purity Type I Collagen serves as a bioactive scaffold promoting cellular migration and early tissue integration. This study assesses early safety signals, feasibility metrics, patient-reported outcomes, and MRI-based healing characteristics following collagen-augmented meniscal repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 55 years
- •Symptomatic meniscal tear confirmed on MRI and indicated for arthroscopic repair
- •Tear patterns amenable to repair
- •Stable knee or concomitant ACL reconstruction permitted
- •Ability to comply with rehabilitation and follow-up
- •Written informed consent provided
排除标准
- •Advanced knee osteoarthritis (Kellgren-Lawrence grade ≥3)
- •Irreparable meniscal tears requiring meniscectomy
- •Active joint infection or inflammatory arthritis
- •Prior surgical repair of the index meniscus
- •Known hypersensitivity to collagen products
- •Systemic conditions impairing wound healing