NCT04462458

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jul 2022Jan 2027

First Submitted

Initial submission to the registry

July 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

July 2, 2020

Last Update Submit

March 10, 2023

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    Kaplan Meier method

    6 months

Secondary Outcomes (5)

  • Survival rate

    1, 12, 24 months

  • Functional outcome

    1, 6, 12, 24 months

  • Quality of Life outcome

    1, 6, 12, 24 months

  • Radiological outcome (optional)

    1, 6, 12, 24 months

  • Complication rate

    intraoperative, 1, 6, 12, 24 months

Interventions

Medacta Anatomic Ribbon Surgery (M-ARS ACL)DEVICE

M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients older than 18 years
  • Patients with ACL rupture requiring ACL reconstruction

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Praxis Gelenkpunkt - Sport- und Gelenkchirurgie

Innsbruck, 6020, Austria

RECRUITING

Pyhrn-Eisenwurzen Klinikum Kirchdorf

Kirchdorf an der Krems, 4560, Austria

RECRUITING

OCM Klinik GmbH

München, 81369, Germany

RECRUITING

Study Officials

  • Mirco Herbort, Prof. Dr. med.

    OCM Klinik GmbH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Falcone

CONTACT

+41916966060falcone@medacta.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 8, 2020

Study Start

July 1, 2022

Primary Completion

July 1, 2025

Study Completion (Estimated)

January 1, 2027

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations

DE(1)AU(2)