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
27 participants
OBSERVATIONAL
2023-10-19
2026-01-31
Brief Summary
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Detailed Description
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Patients with an ACL or PCL tear scheduled for surgery at OCM Klnik GmbH hospital 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-B, Medacta International SA). Data concerning demography, preoperative clinical conditions, surgical details including device implanted, tendon harvesting procedure and complications occurred, postoperative clinical data (as per standard practice at 6 weeks, 6 and/or 12 months) will be prospectively collected, 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 by std x-ray according to standard practice to assess swelling, tunnel widening, and resorption problems. 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
Study Groups
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Mectascrew B
Mectascrew B
reconstruction of ACL or PCL rupture
Interventions
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Mectascrew B
reconstruction of ACL or PCL rupture
Eligibility Criteria
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Inclusion Criteria
* 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 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 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)
18 Years
ALL
No
Sponsors
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Medacta International SA
INDUSTRY
Responsible Party
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Locations
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OCM Klinik GmbH
Münich, , Germany
Countries
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Facility Contacts
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Mirco Herbort, Prof Dr
Role: primary
Other Identifiers
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P07.001.08
Identifier Type: -
Identifier Source: org_study_id