Interference Screw Mectascrew-B Postmarket Study

Cinical Outcomes of Mectascrew B Interference Screw

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear
• Intervention / Treatment: Device: Mectascrew B

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 Type: Observational
• Enrollment (Estimated): 27

Contacts and Locations

Study Locations

• Germany
  • Münich, Germany, 81369
    • Recruiting
    • OCM Klinik GmbH
    • Contact: Mirco Herbort, Prof Dr; Phone Number: +49 89.206082-0; Email: Mirco.Herbort@ocm-muenchen.de
    • Principal Investigator: Mirco Herbort, Prof Dr Med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with an ACL or PCL rupture, and meeting the inclusion/ exclusion criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mectascrew B	Device: Mectascrew B; reconstruction of ACL or PCL rupture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcomes evaluation	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).	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medacta International SA

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: P07.001.08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes