M-ARS ACL Post-marketing Surveillance Study
- Conditions
- Anterior Cruciate Ligament (ACL) Reconstruction
- Registration Number
- NCT04462458
- Lead Sponsor
- Medacta International SA
- Brief Summary
The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction.
The main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The secondary goals are to assess the survival rate, clinical and functional outcomes, the quality of life, and the rate of complications at 1 month, 1 year and 2 years post-operatively.
- Detailed Description
This s a prospective, multicenter, non-controlled, observational study to evaluate the outcomes of Medacta Anatomic Ribbon Surgery (M-ARS) in the reconstruction of the anterior cruciate ligament (ACL).
Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.
The study is conducted according to the following schedule:
* V1 : Inclusion during a preoperative visit
* V2: Surgery
* V3: Follow-up visit at 1 month ± 15 days post-surgery
* V4: Follow-up visit at 6 months ± 30 days post-surgery
* V5: Follow-up visit at 12 months ± 60 days post-surgery
* V6: Follow-up visit at 24 months ± 90 days post-surgery
The following data will be collected:
* Survival rate of implants evaluating the incidence of implants failure, where implant failure is defined as revision, loosening, or any definite change in the position of components (V3-V6).
* Clinical and functional outcomes, measured with the International Knee Documentation Committee (IKDC) score (V1, V3-V6)
* Quality of Life, measured with the EQ-5D score (V1, V3-V6)
* Occurrence of intraoperative and postoperative complications (V2-V6)
Depending on standard practice, imaging assessment of implants and bone tunnels may be performed.
A web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF).
The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Patients older than 18 years
- Patients with ACL rupture requiring ACL reconstruction
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspected infections (at the time of surgery)
- Patients with functional deficits of the affected extremity (at the time of surgery)
- Patients with known incompatibility or allergy to products materials (at the time of surgery)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival rate 6 months Kaplan Meier method
- Secondary Outcome Measures
Name Time Method Functional outcome 1, 6, 12, 24 months International Knee Documentation Committee (IKDC) score
Quality of Life outcome 1, 6, 12, 24 months EQ-5D score
Complication rate intraoperative, 1, 6, 12, 24 months Occurrence of intraoperative and postoperative complications
Survival rate 1, 12, 24 months Kaplan Meier method
Radiological outcome (optional) 1, 6, 12, 24 months Evaluation of ligament osteointegration, femoral/tibial tunnel widening, presence of fluid in the femoral/tibial tunnel
Trial Locations
- Locations (3)
Praxis Gelenkpunkt - Sport- und Gelenkchirurgie
🇦🇹Innsbruck, Austria
Pyhrn-Eisenwurzen Klinikum Kirchdorf
🇦🇹Kirchdorf An Der Krems, Austria
OCM Klinik GmbH
🇩🇪München, Germany