Comparison of Six-Month Functional Outcomes Following Anterior Cruciate Ligament (ACL) Reconstruction Using Peroneus Longus Tendon Grafts With Adjunctive Secretome Injection Versus Without Secretome Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
研究概览
简要总结
Anterior cruciate ligament (ACL) reconstruction is commonly performed to restore knee stability after ACL injury; however, graft healing remains a critical determinant of successful outcomes. This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of adjunctive MSC-derived secretome injection administered to the graft during arthroscopic single-bundle ACL reconstruction using a peroneus longus tendon autograft. Twenty-four participants were randomized to receive either secretome injection or placebo. Functional outcomes were assessed using the IKDC Subjective Knee Evaluation Form and the Tegner-Lysholm Knee Scoring Scale before surgery and at six months postoperatively. The study evaluated whether adjunctive secretome injection could improve functional recovery compared with placebo while monitoring treatment safety.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete anterior cruciate ligament (ACL) rupture confirmed by magnetic resonance imaging (MRI).
- •Positive pivot-shift test.
- •Positive Lachman test.
- •Positive anterior drawer test.
- •Scheduled to undergo arthroscopic ACL reconstruction using a peroneus longus tendon autograft.
- •Surgery performed by the same surgical team.
- •Age 18 to <40 years.
排除标准
- •Partial ACL tear.
- •History of previous ACL reconstruction surgery.
- •Multi-ligament knee injury involving more than two ligaments.
- •Generalized ligamentous laxity confirmed using the Beighton Hypermobility Score.
- •Unwilling or unable to comply with the scheduled follow-up through 6 months postoperatively.
结局指标
主要结局
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
时间窗: Baseline (preoperative) and 6 months after surgery
The IKDC Subjective Knee Evaluation Form assesses symptoms, knee function, and ability to perform sports activities. Scores range from 0 to 100, with higher scores indicating better knee function.
Tegner-Lysholm Knee Scoring Scale
时间窗: Baseline (preoperative) and 6 months postoperatively.
The Tegner-Lysholm Knee Scoring Scale evaluates knee function, pain, instability, locking, swelling, stair climbing, squatting, limp, and need for support. Scores range from 0 to 100, with higher scores indicating better functional outcomes.
次要结局
未报告次要终点