The Medacta International GMK Sphere Post-Marketing Surveillance Study
NCT ID: NCT02199600
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
500 participants
INTERVENTIONAL
2012-10-31
2029-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GMK Sphere Knee Replacement
Patients who comply with the protocol and received GMK Sphere component.
GMK Sphere Knee Replacement
Interventions
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GMK Sphere Knee Replacement
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Medacta International SA
INDUSTRY
Responsible Party
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Locations
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AZ Maria Middelares
Ghent, , Belgium
Royal London Hospital
Whitechapel, London, United Kingdom
Royal National Orthopaedic Hospital NHS Trust
Stanmore, Middlesex, United Kingdom
The Elective Orthopaedic Centre (EOC)
Epsom, Surrey, United Kingdom
Countries
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Other Identifiers
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P02.014.01
Identifier Type: -
Identifier Source: org_study_id