Long Term Clinical and Radiographical Outcomes of Different Anterior Cruciate Ligament Reconstruction Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Failure and complications
研究概览
简要总结
The purpose of this study is to evaluate the long-term results of various anterior cruciate ligament reconstruction techniques. This assessment is necessary for the current context of anterior cruciate ligament research as several techniques and grafts are used in clinical practice, however, the various studies existing in the literature focus mainly only on the direct comparison of two techniques and usually with short-to-medium term follow-up. Since gonarthrosis is one of the most debated consequences of cruciate ligament reconstruction, a comparison of different long-term procedures would be desirable to have a clearer picture of the risks and benefits associated with different types of intervention.
详细描述
In the beginning, the Database of our Institute is consulted, all the patients that underwent ACL reconstruction at least 15 years ago are selected. The original group will be divided into subgroups based on the surgical technique adopted, of the different techniques we took into consideration only these three: anatomical ACL reconstruction with patellar tendon, anatomical ACL reconstruction with hamstrings, non-anatomical ACL reconstruction "Over-the-top plus lateral plasty". The patients will be contacted to ask if they are interested to take part in the study; at least 25 patients for each group will be recruited. All the patients recruited will sign an informed consent about the study and the personal data treatment. After consent acquisition, patients will undergo a clinical examination and a questionnaire about pain and knee status will be administered; moreover, a radiographical examination of the operated knee will be performed to assess the osteoarthritis progression. Patients that reported graft rupture will be registered as failures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent ACL reconstruction with single-bundle anatomical technique (patellar tendon, semitendinous and gracile tendons) or "Over-The-Top plus lateral plastic" technique and any associated procedures with at least 15 years of follow up;
- •Patients aged between 15 and 50 at the time of surgery;
- •Patients with isolated ACL tear;
- •Patients with healthy contralateral knee at the time of surgery.
排除标准
- •Patients with grade III-IV chondral lesions according to Outerbridge scale at surgery;
- •Patients no longer available;
- •Women of childbearing age who cannot exclude pregnancy;
- •Patients unable to give informed consent or patients unwilling to sign informed consent.
结局指标
主要结局
Failure and complications
时间窗: Two years
Failures and complication rate for each arm of the study
Subjective and objective International Knee Documentation Committee
时间窗: Two years
Clinical scores widely used to assess knee function and symptoms Values: 0 (worst score) to 100 (best score) for subjective IKDC; A (best score)-B-C-D (worst score) for objective IKDC (International Knee Documentation Committee)
Knee Laxity
时间窗: Two years
Assessment of knee anterior posterior laxity and quantification of Pivot shift using measurement devices (KT-1000; Kira)
VAS pain
时间窗: Two years
Numerical score to quantitatively assess the intensity of pain (0-10)
Kellgreen-Lawrence
时间窗: Two years
Radiographical score that graded knee ostheoarthritis
次要结局
- Anterior knee pain(Two years)
- Tight circumference(Two years)
- Lysholm knee scoring scale(Two years)
- Tegner activity scale(Two years)
- Short Form-36 Health Survey(Two years)
- Global satisfaction about the surgical procedure(Two years)