The Medacta International GMK Sphere Post-Marketing Surveillance Study

December 11, 2024 updated by: Medacta International SA
This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The clinical performance of the GMK® Sphere, manufactured by Medacta International, will be evaluated by a multicentre, prospective clinical surveillance study.

The Elective Orthopaedic Centre (EOC), in Epsom, Surrey, will be the study coordinating centre. Four further centres will participate in the clinical study, for five total centres. Each participating centre will recruit approximately 100 patients. Patient recruitment will cease when a cohort of 500 GMK® Sphere knee replacements have been implanted.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • AZ Maria Middelares
  • United Kingdom
    • London
      • Whitechapel, London, United Kingdom, E11BB
        • Royal London Hospital
    • Middlesex
      • Stanmore, Middlesex, United Kingdom, HA74LP
        • Royal National Orthopaedic Hospital NHS Trust
    • Surrey
      • Epsom, Surrey, United Kingdom, KT18 7EG
        • The Elective Orthopaedic Centre (EOC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
  • Patients must be between the age of 18 and 80 at the time of consent
  • Listed for total knee replacement surgery.
  • Patients who are willing 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 condylar structures or loss of integrity of the medial or lateral ligament
  • Any patient who cannot or will not provide informed consent for participation in the study
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: GMK Sphere Knee Replacement
Patients who comply with the protocol and received GMK Sphere component.
Device: GMK Sphere Knee Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the clinical outcome following total knee replacement using the Knee Society Score.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The OXFORD score as a measure of implant functionality.
Time Frame: pre-op, 6 months and annually for 10 years
pre-op, 6 months and annually for 10 years
Assessment of implant survivorship as a measure of safety and tolerability.
Time Frame: 6 weeks, 6 months, 3, 5, 7 and 10 years.
6 weeks, 6 months, 3, 5, 7 and 10 years.
Radiographic analysis
Time Frame: pre-op, 6 months, 3, 5,7 and 10 years.
pre-op, 6 months, 3, 5,7 and 10 years.
The EuroQol score as a measure of patient' quality of life.
Time Frame: pre-op, 6 months, 3, 5,7 and 10 years
pre-op, 6 months, 3, 5,7 and 10 years
Assessment of the clinical outcome following total knee replacement using the Knee Society Score
Time Frame: pre-op, at 6 months, at 3, 5, 7 and 10 years.
pre-op, at 6 months, at 3, 5, 7 and 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medacta International SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimated)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P02.014.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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