NCT04462458 M-ARS ACL Post-marketing Surveillance Study
| NCT ID | NCT04462458 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medacta International SA |
| Condition | Anterior Cruciate Ligament (ACL) Reconstruction |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-07-01 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Patients older than 18 years * Patients with ACL rupture requiring ACL reconstruction Exclusion Criteria: * 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)
Contact & Investigator
Mirco Herbort, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
OCM Klinik GmbH
Frequently Asked Questions
Who can join the NCT04462458 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anterior Cruciate Ligament (ACL) Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04462458 currently recruiting?
Yes, NCT04462458 is actively recruiting participants. Contact the research team at falcone@medacta.ch for enrollment information.
Where is the NCT04462458 trial being conducted?
This trial is being conducted at Innsbruck, Austria, Kirchdorf an der Krems, Austria, München, Germany.
Who is sponsoring the NCT04462458 clinical trial?
NCT04462458 is sponsored by Medacta International SA. The principal investigator is Mirco Herbort, Prof. Dr. med. at OCM Klinik GmbH. The trial plans to enroll 200 participants.