ACL Reconstruction With Quadriceps Tendon Graft vs. Quadrupled Semitendinosus Graft: A Comparison of Patients From the Danish National ACL Reconstruction Database
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- The Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
This study looks at two different types of tendon (tissue) used in knee surgery to repair a torn anterior cruciate ligament (ACL), which is a common injury in active people. The two types are taken from different muscles in the thigh: one from the front (quadriceps) and one from the back (semitendinosus). We will use information already collected in a national health registry to see how patients recover after surgery. The study will compare knee function, activity level, and how often patients need another operation.
详细描述
This is a retrospective observational cohort study based on data from the Danish Knee Ligament Reconstruction Registry (DKRR). The study includes patients who underwent primary ACL reconstruction using either a quadriceps tendon graft (with or without a bone block) or a quadrupled semitendinosus tendon graft. The primary outcome measures are the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Tegner Activity Scale. Secondary outcomes include reoperation rates, postoperative complications, and patient satisfaction. All available demographic, operative, and patient-reported outcome data will be analyzed. Multivariable regression will be used to adjust for confounders such as age, sex, BMI, time from injury to surgery, and surgeon volume. The study is exempt from ethical approval under Danish law, and data will be handled in compliance with GDPR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary ACL reconstruction registered in the Danish Knee Ligament Reconstruction Registry (DKRR)
- •Known graft type: quadriceps tendon or semitendinosus tendon Minimum 1-year follow-up with completed patient-reported outcome measures (KOOS and/or Tegner score)
- •Age between 15 and 50 years at the time of surgery (optional subgroup analysis)
排除标准
- •Revision ACL reconstruction
- •Multiligament knee reconstruction
- •Missing or incomplete PROMs or key clinical data
结局指标
主要结局
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: At minimum 1 year follow up postoperatively
The Knee Injury and Osteoarthritis Outcome Score (KOOS) evaluates pain, symptoms, daily living, sport/recreation, and knee-related quality of life. Metric type: continuous PROM-based subscale score Method of measurement: Self reported questionnaire
Tegner Activity Score
时间窗: Minimum 1 year follow up postoperatively.
Assesses patients' level of physical activity before injury and at follow-up. Metric type: Scale from 0-10, where 0 is no physical activity caused by knee problems and 10 is an ability to compete in elite level sport like soccer and ski. Method of measurement: Tegner scale, self reported
次要结局
- Postoperative complications(Within 1 year after surgery)
- Re-operation rate(Within 1 year of surgery)
- Patient satisfaction(1 year follow up)
研究者
Abdirahman Hassan Omar
Medical student, Principal incestigator
Søernes Privathospital