Interference Screw Mectascrew-B Postmarket Study

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear
• Interventions: Device: Mectascrew B

• Registration Number: NCT06166784
• Lead Sponsor: Medacta International SA

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 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

Study Timeline

• Study Start: 2023-10-19
• Status Verified: 2023-11
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Primary Completion: 2025-11
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mectascrew B	Mectascrew B	-

Primary Outcome Measures

Name	Time	Method
Functional outcomes evaluation	12 months	Assessment throught IKCD score. a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

Secondary Outcome Measures

Name	Time	Method
Mobility outcomes evaluation	6 weeks, 6 months, 12 months	Assessment throught Range Of Motion of operated knee calculated as degree
PCL integrity assessment	6 weeks, 6 months, 12 months	Posterior drawer test. The test is considered positive if there is a lack of end feel or excessive posterior translation
Interference screw integration	6 weeks, 6 months, 12 months	Evaluation of ligament osteointegration, femoral/tibial tunnel widening, presence of fluid in the femoral/tibial tunnel by std x-ray
Knee stability evaluation of ACL intervention	6 weeks, 6 months, 12 months	Pivot shift test. A positive test indicate an injury at ACL
ACL integrity assessment	6 weeks, 6 months, 12 months	Anterior drawer test. An anterior translation more than 6 mm indicate a positive test with injuried ACL
Knee stability evaluation of PCL intervention	6 weeks, 6 months, 12 months	Reverse Pivot Shift test. In the presence of a posterolateral injury with the knee flexed, the tibia follows gravity and drops into posterolateral subluxation (positive Reverse Pivot Shift Test).
Incidence of adverse event	6 weeks, 6 months, 12 months	collection of adverse event

Trial Locations

Locations (1)

OCM Klinik GmbH; 🇩🇪 Münich, Germany