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Active Not RecruitingNCT02199600

The Medacta International GMK Sphere Post-Marketing Surveillance Study

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
500 (estimated)
Sponsor
Medacta International SA · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DEVICEGMK Sphere Knee Replacement

Timeline

Start date
2012-10-01
Primary completion
2029-10-01
Completion
2029-10-01
First posted
2014-07-24
Last updated
2024-12-16

Locations

4 sites across 2 countries: Belgium, United Kingdom

Source: ClinicalTrials.gov record NCT02199600. Inclusion in this directory is not an endorsement.