Interference Screw Mectascrew-C Postmarket Study

Composite Interference Screw in the Surgical Reconstruction of Knee Cruciate Ligaments: a Prospective Observational Study

An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) 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-C

Detailed Description

This is an observational prospective study with the aim to determine the presence of the composite IS (Mectascrew-C) at 6 months following ACL or PCL reconstruction.

Patients with an ACL or PCL tear scheduled for surgery at one of the EOC's hospitals 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-C, 70% PLDLLA, 30% β-TCP, Medacta International SA).

The data will be collected from patient's medical histories (data about diagnosis, patients' characteristics and surgery) and after operation, during the orthopaedic follow-up visits, planned at 1, 3 and 6 months, 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 with an MRI at 6 months to assess the IS reabsorption. 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): 44

Contacts and Locations

• Study Contact: Name: Elisa Bonacina, PhD; Phone Number: +41 91 696 60 60; Email: bonacina@medacta.ch

Study Locations

• Switzerland
  • Lugano, Switzerland, CH-6962
    • Recruiting
    • EOC, Service of Orthopaedics and Traumatology
    • Contact: Alessandro Sangiorgio, Dr; Email: Alessandro.Sangiorgio@eoc.ch
    • Principal Investigator: Christian Candrian, Prof Dr Med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, 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:

• Patients of both sexes aged 16-60 yrs
• Pre-operative MRI confirming the ACL or PCL rupture
• Scheduled for surgical reconstruction of ACL or PCL
• BMI>18 and <35 kg/m2
• Ability to give informed consent by signature

Exclusion Criteria:

• Age under 16 or over 60 yrs
• Degenerative osteopathies
• Local bone tumors
• Deformities of the bone, or general conditions of the bone, which preclude the implantation in the opinion of a physician
• Systemic diseases and metabolic disorders that may compromise the outcome of the surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interference screw presence	via MRI imaging at 6 months after surgery, the presence of the Mectascrew-C will be assessed	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility outcomes evaluation	Assessment throught Range Of Motion of operated knee calculated as degree	1, 3 and 6 months
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).	1, 3 and 6 months
Knee stability evaluation of ACL intervention	Pivot shift test. A positive test indicate an injury at ACL	1, 3 and 6 months
ACL integrity assessment	Anterior drawer test. An anterior translation more than 6 mm indicate a positive test with injuried ACL	1, 3 and 6 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).	1, 3 and 6 months
PCL integrity assessment	Posterior drawer test. The test is considered positive if there is a lack of end feel or excessive posterior translation.	1, 3 and 6 months
Device safety evaluation	collection of adverse event	1, 3 and 6 months

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Christian Candrian, Prof Med, EOC , Service of Orthopaedics and Traumatology, Lugano (Switzerland)

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

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: P07.001.09

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
• product manufactured in and exported from the U.S.: No