Composite Interference Screw in the Surgical Reconstruction of Knee Cruciate Ligaments: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Interference screw presence
研究概览
简要总结
An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.
详细描述
This is an observational prospective study with the aim to determine the presence of the composite IS (Mectascrew-C) at 6 months following ACL or PCL reconstruction.
Patients with an ACL or PCL tear scheduled for surgery at one of the EOC's hospitals will be enrolled in the study, after the subscription of informed consent. The injured ligament will be restored with an auto- or allograft that will be fixed with a composite IS (Mectascrew-C, 70% PLDLLA, 30% β-TCP, Medacta International SA).
The data will be collected from patient's medical histories (data about diagnosis, patients' characteristics and surgery) and after operation, during the orthopaedic follow-up visits, planned at 1, 3 and 6 months, in order to assess the functional outcomes (IKDC objective and subjective) and the knee stability (ROM, Pivot Shift or Reverse Pivot Shift test, anterior or posterior drawer test) of the patients.
The treated knee will be also evaluated radiologically with an MRI at 6 months to assess the IS reabsorption. The results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged 16-60 yrs
- •Pre-operative MRI confirming the ACL or PCL rupture
- •Scheduled for surgical reconstruction of ACL or PCL
- •BMI>18 and <35 kg/m2
- •Ability to give informed consent by signature
排除标准
- •Age under 16 or over 60 yrs
- •Degenerative osteopathies
- •Local bone tumors
- •Deformities of the bone, or general conditions of the bone, which preclude the implantation in the opinion of a physician
- •Systemic diseases and metabolic disorders that may compromise the outcome of the surgery
结局指标
主要结局
Interference screw presence
时间窗: 6 months
via MRI imaging at 6 months after surgery, the presence of the Mectascrew-C will be assessed
次要结局
- Functional outcomes evaluation(1, 3 and 6 months)
- Mobility outcomes evaluation(1, 3 and 6 months)
- ACL integrity assessment(1, 3 and 6 months)
- Knee stability evaluation of PCL intervention(1, 3 and 6 months)
- Device safety evaluation(1, 3 and 6 months)
- Knee stability evaluation of ACL intervention(1, 3 and 6 months)
- PCL integrity assessment(1, 3 and 6 months)