Interference Screw Mectascrew-C Postmarket Study
- Conditions
- Posterior Cruciate Ligament TearAnterior Cruciate Ligament Injuries
- Registration Number
- NCT05791656
- Lead Sponsor
- Medacta International SA
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Interference screw presence 6 months via MRI imaging at 6 months after surgery, the presence of the Mectascrew-C will be assessed
- Secondary Outcome Measures
Name Time Method Functional outcomes evaluation 1, 3 and 6 months Assessment throught IKCD score. a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Mobility outcomes evaluation 1, 3 and 6 months Assessment throught Range Of Motion of operated knee calculated as degree
ACL integrity assessment 1, 3 and 6 months Anterior drawer test. An anterior translation more than 6 mm indicate a positive test with injuried ACL
Knee stability evaluation of PCL intervention 1, 3 and 6 months Reverse Pivot Shift test. In the presence of a posterolateral injury with the knee flexed, the tibia follows gravity and drops into posterolateral subluxation (positive Reverse Pivot Shift Test).
Device safety evaluation 1, 3 and 6 months collection of adverse event
Knee stability evaluation of ACL intervention 1, 3 and 6 months Pivot shift test. A positive test indicate an injury at ACL
PCL integrity assessment 1, 3 and 6 months Posterior drawer test. The test is considered positive if there is a lack of end feel or excessive posterior translation.
Trial Locations
- Locations (1)
EOC, Service of Orthopaedics and Traumatology
🇨🇭Lugano, Switzerland