Clinical trial NCT04462458: M-ARS ACL Post-marketing Surveillance Study
Official title: Clinical and Radiological Outcomes of M-ARS ACL
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament (ACL) Reconstruction
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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)

Primary outcomes:
measure: Survival rate
timeFrame: 6 months
Secondary outcomes:
measure: Survival rate
timeFrame: 1, 12, 24 months
measure: Functional outcome
timeFrame: 1, 6, 12, 24 months
measure: Quality of Life outcome
timeFrame: 1, 6, 12, 24 months
measure: Radiological outcome (optional)
timeFrame: 1, 6, 12, 24 months
measure: Complication rate
timeFrame: intraoperative, 1, 6, 12, 24 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Praxis Gelenkpunkt - Sport- und Gelenkchirurgie
city: Kirchdorf An Der Krems
country: Austria
facility: Pyhrn-Eisenwurzen Klinikum Kirchdorf
city: München
country: Germany
facility: OCM Klinik GmbH
Study officials:
affiliation: OCM Klinik GmbH
name: Mirco Herbort, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: