NCT05791656

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

March 7, 2023

Last Update Submit

April 30, 2024

Conditions

Anterior Cruciate Ligament InjuriesPosterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (1)

  • Interference screw presence

    via MRI imaging at 6 months after surgery, the presence of the Mectascrew-C will be assessed

    6 months

Secondary Outcomes (7)

  • Mobility outcomes evaluation

    1, 3 and 6 months

  • Functional outcomes evaluation

    1, 3 and 6 months

  • Knee stability evaluation of ACL intervention

    1, 3 and 6 months

  • ACL integrity assessment

    1, 3 and 6 months

  • Knee stability evaluation of PCL intervention

    1, 3 and 6 months

  • +2 more secondary outcomes

Interventions

Mectascrew-CDEVICE

reconstruction of ACL or PCL rupture

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EOC, Service of Orthopaedics and Traumatology

Lugano, CH-6962, Switzerland

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Christian Candrian, Prof Med

    EOC , Service of Orthopaedics and Traumatology, Lugano (Switzerland)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Bonacina, PhD

CONTACT

+41 91 696 60 60bonacina@medacta.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 30, 2023

Study Start

March 22, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)