NCT06166784

Interference Screw Mectascrew-B Postmarket Study

Cinical Outcomes of Mectascrew B Interference Screw

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 27 (estimated)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 reconstruction. 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

• Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear

Interventions

Type	Name	Description
DEVICE	Mectascrew B	reconstruction of ACL or PCL rupture

Timeline

• Start date: 2023-10-19
• Primary completion: 2025-11-01
• Completion: 2026-01-01
• First posted: 2023-12-12
• Last updated: 2023-12-12

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study