M-ARS ACL Post-marketing Surveillance Study

Clinical and Radiological Outcomes of M-ARS ACL

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament (ACL) Reconstruction
• Intervention / Treatment: Device: Medacta Anatomic Ribbon Surgery (M-ARS ACL)

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Denise Falcone; Phone Number: +41916966060; Email: falcone@medacta.ch

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Praxis Gelenkpunkt - Sport- und Gelenkchirurgie
    • Contact: Christian Fink, Prof. Dr. med.
  • Kirchdorf An Der Krems, Austria, 4560
    • Recruiting
    • Pyhrn-Eisenwurzen Klinikum Kirchdorf
    • Contact: Simone Danese, OA Dr.
• Germany
  • München, Germany, 81369
    • Recruiting
    • OCM Klinik GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring ACL reconstruction and who are suitable to receive M-ARS ACL will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	Kaplan Meier method	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	Kaplan Meier method	1, 12, 24 months
Functional outcome	International Knee Documentation Committee (IKDC) score	1, 6, 12, 24 months
Quality of Life outcome	EQ-5D score	1, 6, 12, 24 months
Radiological outcome (optional)	Evaluation of ligament osteointegration, femoral/tibial tunnel widening, presence of fluid in the femoral/tibial tunnel	1, 6, 12, 24 months
Complication rate	Occurrence of intraoperative and postoperative complications	intraoperative, 1, 6, 12, 24 months

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Mirco Herbort, Prof. Dr. med., OCM Klinik GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: P07.001.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No