M-ARS ACL Post-marketing Surveillance Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedacta International SA
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 18 years
Patients with ACL rupture requiring ACL reconstruction
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Medacta Anatomic Ribbon Surgery (M-ARS ACL)
DeviceM-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Survival rate
Kaplan Meier method
Time frame
6 monthsSecondary outcomes
1
Survival rate
Kaplan Meier method
Time frame
1, 12, 24 months2
Functional outcome
International Knee Documentation Committee (IKDC) score
Time frame
1, 6, 12, 24 months3
Quality of Life outcome
EQ-5D score
Time frame
1, 6, 12, 24 months4
Radiological outcome (optional)
Evaluation of ligament osteointegration, femoral/tibial tunnel widening, presence of fluid in the femoral/tibial tunnel
Time frame
1, 6, 12, 24 monthsSponsors and contacts
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Source ClinicalTrials.gov