RecruitingNCT05791656
Interference Screw Mectascrew-C Postmarket Study
Composite Interference Screw in the Surgical Reconstruction of Knee Cruciate Ligaments: a Prospective Observational Study
Sponsor
Medacta International SA
Enrollment
44 participants
Start Date
Mar 22, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.
Eligibility
Min Age: 16 YearsMax Age: 60 Years
Inclusion Criteria5
- Patients of both sexes aged 16-60 yrs
- 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 Criteria5
- Age under 16 or over 60 yrs
- 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
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Interventions
DEVICEMectascrew-C
reconstruction of ACL or PCL rupture
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05791656
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