Evaluating Medacta Anatomic Ribbon Surgery for ACL Reconstruction
Clinical and Radiological Outcomes of M-ARS ACL
Medacta International SA · NCT04462458
This study is testing how well a new surgery technique for ACL reconstruction works and how it affects patients' recovery and quality of life over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medacta International SA (industry) |
| Locations | 3 sites (Innsbruck and 2 other locations) |
| Trial ID | NCT04462458 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients undergoing anterior cruciate ligament (ACL) reconstruction. It will evaluate the survival rate of the M-ARS implants at 6 months post-surgery, along with clinical and functional outcomes, quality of life, and complication rates at 1 month, 1 year, and 2 years post-operatively. Participants will be monitored through a series of follow-up visits, and data will be collected using a web-based tool to ensure accurate tracking of outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed ACL rupture requiring surgical reconstruction.
Not a fit: Patients with malignant diseases, infections, functional deficits of the affected limb, or known allergies to surgical materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness and safety of M-ARS for ACL reconstruction, potentially improving patient outcomes.
How similar studies have performed: While this study focuses on a specific surgical technique, similar observational studies have shown promising results in evaluating surgical outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Innsbruck and 2 other locations
- Praxis Gelenkpunkt - Sport- und Gelenkchirurgie — Innsbruck, Austria (RECRUITING)
- Pyhrn-Eisenwurzen Klinikum Kirchdorf — Kirchdorf an der Krems, Austria (RECRUITING)
- OCM Klinik GmbH — München, Germany (RECRUITING)
Study contacts
- Principal investigator: Mirco Herbort, Prof. Dr. med. — OCM Klinik GmbH
- Study coordinator: Denise Falcone
- Email: falcone@medacta.ch
- Phone: +41916966060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anterior Cruciate Ligament Reconstruction