The Medacta International GMK Sphere Post-Marketing Surveillance Study

Study Overview
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Brief Summary
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This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.

Detailed Description
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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.

Official Title
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The Medacta International GMK Sphere Post-Marketing Surveillance Study

Conditions
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Arthritis, Traumatic Arthritis, Rheumatoid Arthritis, Poly-arthritis, Avascular Necrosis

Intervention / Treatment
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* Device: GMK Sphere Knee Replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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