Evaluating Medacta Anatomic Ribbon Surgery for ACL Reconstruction
Official title: Clinical and Radiological Outcomes of M-ARS ACL
Run by Medacta International SA · NCT04462458 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 3 sites (Innsbruck and 2 other locations) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | July 2025 |
| Study ends | January 2027 |
| Registry record updated | March 13, 2023 |
| Trial ID | NCT04462458 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old with a confirmed ACL rupture requiring surgical reconstruction.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this study focuses on a specific surgical technique, similar observational studies have shown promising results in evaluating surgical outcomes, suggesting potential for success.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Bone-patellar tendon–bone graft versus patellar tendon graft for ACL reconstruction
This randomized comparison tests whether a patellar tendon graft without the patellar bone plug reduces donor-site problems and gives similar knee function to the standard bone–patellar tendon–bone graft in athletes undergoing ACL reconstruction.
-
Phone app vs supervised preoperative exercise for ACL reconstruction
This trial tests whether a mobile app-guided preoperative exercise plan works as well as in-person therapy or no specific plan for people awaiting ACL reconstruction.
-
Absorbable oxandrolone implant to help recovery after ACL reconstruction
This test will see if a bioabsorbable oxandrolone pellet placed under the skin helps men and women recover muscle mass, strength, and knee function after ACL reconstruction.
-
Mindfulness intervention for recovery after ACL reconstruction
This study tests if mindfulness practices can help people recovering from ACL surgery feel less pain and anxiety while getting back to sports.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.