Interference Screw Mectascrew-C Postmarket Study

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791656
• Other study ID #: P07.001.09
• Status: Recruiting
• Start date: March 22, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Medacta International SA
• Contact: Elisa Bonacina, PhD
• Phone: +41 91 696 60 60
• Email: bonacina[@]medacta.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Posterior Cruciate Ligament Tear

Intervention

Device:
• Mectascrew-C
reconstruction of ACL or PCL rupture

Locations

Country	Name	City	State
Switzerland	EOC, Service of Orthopaedics and Traumatology	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interference screw presence	via MRI imaging at 6 months after surgery, the presence of the Mectascrew-C will be assessed	6 months
Secondary	Mobility outcomes evaluation	Assessment throught Range Of Motion of operated knee calculated as degree	1, 3 and 6 months
Secondary	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
Secondary	Knee stability evaluation of ACL intervention	Pivot shift test. A positive test indicate an injury at ACL	1, 3 and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Device safety evaluation	collection of adverse event	1, 3 and 6 months