RecruitingNCT05791656

Interference Screw Mectascrew-C Postmarket Study

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


Sponsor

Medacta International SA

Enrollment

44 participants

Start Date

Mar 22, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 60 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

DEVICEMectascrew-C

reconstruction of ACL or PCL rupture


Locations(1)

EOC, Service of Orthopaedics and Traumatology

Lugano, Switzerland

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NCT05791656


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