Clinical trial NCT05791656: Interference Screw Mectascrew-C Postmarket Study
Official title: Composite Interference Screw in the Surgical Reconstruction of Knee Cruciate Ligaments: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Injuries
Posterior Cruciate Ligament Tear
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2023-03-30
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with an ACL or PCL rupture, and meeting the inclusion/exclusion criteria

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Interference screw presence
timeFrame: 6 months
Secondary outcomes:
measure: Mobility outcomes evaluation
timeFrame: 1, 3 and 6 months
measure: Functional outcomes evaluation
timeFrame: 1, 3 and 6 months
measure: Knee stability evaluation of ACL intervention
timeFrame: 1, 3 and 6 months
measure: ACL integrity assessment
timeFrame: 1, 3 and 6 months
measure: Knee stability evaluation of PCL intervention
timeFrame: 1, 3 and 6 months
measure: PCL integrity assessment
timeFrame: 1, 3 and 6 months
measure: Device safety evaluation
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: EOC, Service of Orthopaedics and Traumatology
Study officials:
affiliation: EOC , Service of Orthopaedics and Traumatology, Lugano (Switzerland)
name: Christian Candrian, Prof Med
role: PRINCIPAL_INVESTIGATOR
References: