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
44 participants
OBSERVATIONAL
2023-03-22
2025-03-31
Brief Summary
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Detailed Description
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Patients with an ACL or PCL tear scheduled for surgery at one of the EOC's hospitals will be enrolled in the study, after the subscription of informed consent. The injured ligament will be restored with an auto- or allograft that will be fixed with a composite IS (Mectascrew-C, 70% PLDLLA, 30% β-TCP, Medacta International SA).
The data will be collected from patient's medical histories (data about diagnosis, patients' characteristics and surgery) and after operation, during the orthopaedic follow-up visits, planned at 1, 3 and 6 months, in order to assess the functional outcomes (IKDC objective and subjective) and the knee stability (ROM, Pivot Shift or Reverse Pivot Shift test, anterior or posterior drawer test) of the patients.
The treated knee will be also evaluated radiologically with an MRI at 6 months to assess the IS reabsorption. The results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Mectascrew-C
reconstruction of ACL or PCL rupture
Eligibility Criteria
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Inclusion Criteria
* Pre-operative MRI confirming the ACL or PCL rupture
* Scheduled for surgical reconstruction of ACL or PCL
* BMI\>18 and \<35 kg/m2
* Ability to give informed consent by signature
Exclusion Criteria
* Degenerative osteopathies
* Local bone tumors
* Deformities of the bone, or general conditions of the bone, which preclude the implantation in the opinion of a physician
* Systemic diseases and metabolic disorders that may compromise the outcome of the surgery
16 Years
60 Years
ALL
No
Sponsors
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Medacta International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Christian Candrian, Prof Med
Role: PRINCIPAL_INVESTIGATOR
EOC , Service of Orthopaedics and Traumatology, Lugano (Switzerland)
Locations
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EOC, Service of Orthopaedics and Traumatology
Lugano, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P07.001.09
Identifier Type: -
Identifier Source: org_study_id
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