Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2022-07-01
2027-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Medacta Anatomic Ribbon Surgery (M-ARS ACL)
M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique
Eligibility Criteria
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Inclusion Criteria
* Patients with ACL rupture requiring ACL reconstruction
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Medacta International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Mirco Herbort, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
OCM Klinik GmbH
Locations
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Praxis Gelenkpunkt - Sport- und Gelenkchirurgie
Innsbruck, , Austria
Pyhrn-Eisenwurzen Klinikum Kirchdorf
Kirchdorf an der Krems, , Austria
OCM Klinik GmbH
München, , Germany
Countries
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Central Contacts
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Facility Contacts
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Christian Fink, Prof. Dr. med.
Role: primary
Simone Danese, OA Dr.
Role: primary
Other Identifiers
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P07.001.01
Identifier Type: -
Identifier Source: org_study_id
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