Status:
RECRUITING
Interference Screw Mectascrew-B Postmarket Study
Lead Sponsor:
Medacta International SA
Conditions:
Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear
Eligibility:
All Genders
18+ years
Brief Summary
An observational prospective study with the aim to assess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) in the reconstructive treatment of ruptured AC...
Detailed Description
This is an observational prospective study with the aim toassess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) at 12 months following ACL or PCL recon...
Eligibility Criteria
Inclusion
- Both genders
- Patients older than 18 years
- ACL or PCL damage requiring primary ACL or PCL reconstruction
- Patient requiring ACL or PCL surgery with the use of Medacta MectaScrew B interference screw, according to Manufacturer IFU's, i.e. reconstructive therapy of ruptures to the anterior or posterior cruciate ligament by means of autologous grafts
- Patients who are willing to participate in the study and have signed informed consent form.
Exclusion
- Patients with contraindications according to IFU's
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspected infections (at the time of surgery)
- Patients with functional deficits on the affected extremity (at the time of surgery)
- Patients with known incompatibility or allergy to products materials (at the time of surgery)
- Concomitant ligament injury (grade ≥ 3)
Key Trial Info
Start Date :
October 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06166784
Start Date
October 19 2023
End Date
January 1 2026
Last Update
December 12 2023
Active Locations (1)
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1
OCM Klinik GmbH
Münich, Germany, 81369