M-ARS ACL Post-marketing Surveillance Study

NCT04462458 · tracked via the Priya Life Science Germany tracker

Sponsor

Medacta International SA

Phase

Observational

Started

2022-07-01

Last updated

2023-03-13

Condition(s) studied

Anterior Cruciate Ligament (ACL) Reconstruction

Investigational drug(s) / intervention(s)

Medacta Anatomic Ribbon Surgery (M-ARS ACL)

Medacta Anatomic Ribbon Surgery (M-ARS ACL): M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Survival rate — 6 months
Kaplan Meier method

Trial sites (3)

Facility	City	Region	Status
Praxis Gelenkpunkt - Sport- und Gelenkchirurgie	Innsbruck	Austria	Recruiting
Pyhrn-Eisenwurzen Klinikum Kirchdorf	Kirchdorf an der Krems	Austria	Recruiting
OCM Klinik GmbH	München	Germany	Recruiting

More Medacta International SA trials in Germany

Clinical and Radiological Outcomes of Medacta Shoulder System Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04462458 on ClinicalTrials.gov ↗ ← All trials in Germany