The Medacta GMK SpheriKA Post-Marketing Surveillance Study

Last updated: October 18, 2023
Sponsor: Medacta International SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Knee Replacement

Orthopedic Surgery

Arthritis And Arthritic Pain

Treatment

GMK SpheriKA

Clinical Study ID

NCT05459948
P.02.025.02
  • Ages 18-80
  • All Genders

Study Summary

This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients willing to sign the informed consent.
  • Patients able to comply with follow-up requirements, including postoperativeweight-bearing restrictions and self-evaluations.
  • Patients 18 - 80 years of age at the time of surgery.
  • Patients requiring a primary total knee replacement (on label use).
  • Patients with intact collateral ligaments.

Exclusion

Exclusion Criteria:

  • Patients with inflammatory arthritis.
  • Morbidly obese patients, with a body mass index (BMI) > 40.
  • Patients with a history of total or unicompartmental reconstruction of the affectedjoint.
  • Patients that have had a high tibial osteotomy or femoral osteotomy.
  • Patients with neuromuscular or neurosensory deficiency, which would limit the abilityto assess the performance of the device.
  • Patients with a systemic or metabolic disorder leading to progressive bonedeterioration.
  • Patients that are immunologically compromised or receiving chronic steroids (> 30days).
  • Patients whose bone stock is compromised due to disease or infection, unable toprovide adequate support and/or fixation to the prosthesis.
  • Patients with an active or suspected latent infection in or surrounding the kneejoint.
  • Pregnant or breastfeeding women.

Study Design

Total Participants: 281
Treatment Group(s): 1
Primary Treatment: GMK SpheriKA
Phase:
Study Start date:
July 30, 2022
Estimated Completion Date:
May 31, 2035

Study Description

The aim of the current study is to collect clinical and radiological data to monitor the performances of the "GMK® SpheriKA" Knee Prosthesis implanted via the kinematic alignment technique.

Connect with a study center

  • Centre de l'Arthrose

    Mérignac,
    France

    Active - Recruiting

  • Clinique de l'Union

    Saint-Jean, 31240
    France

    Active - Recruiting

  • Humanitas Castelli

    Bergamo,
    Italy

    Active - Recruiting

  • Gelenkzentrum Winterthur

    Winterthur,
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.