Interference Screw Mectascrew-C Postmarket Study

Medacta

Status: Enrolling

Conditions: Anterior Cruciate Ligament Injuries; Posterior Cruciate Ligament Tear

Treatments: Device: Mectascrew-C

Study type: Observational

Funder types: Industry

Identifiers

NCT05791656

P07.001.09

Details and patient eligibility

About

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.

Full 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

Enrollment: 44 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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