Interference Screw Mectascrew-B Postmarket Study (NCT06166784) | Clinical Trial Compass
UnknownNot Applicable
Interference Screw Mectascrew-B Postmarket Study
Germany27 participantsStarted 2023-10-19
Plain-language 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 ACL or PCL by means of an autograft or allograft.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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)