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The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

Non Recruiting
18-80 years
All
Phase N/A

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Overview

This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.

Eligibility

Inclusion Criteria:

  • A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
  • Patients between the age of 18 and 80 at the time of consent
  • Listed for total knee replacement surgery.
  • Patients who are willing and able to give informed written consent

Exclusion Criteria:

  • Progressive local or systemic infection
  • Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
  • Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
  • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
  • Patient whose BMI exceeds 40
  • Any case not described in the inclusion criteria

Study details
    Arthritis
    Traumatic Arthritis
    Rheumatoid Arthritis
    Poly-arthritis
    Avascular Necrosis

NCT05003414

Medacta International SA

21 October 2025

FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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