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This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GMK Sphere Knee Replacement | Other | Patients who comply with the protocol and received GMK Sphere component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GMK Sphere Knee Replacement | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the clinical outcome following total knee replacement using the Knee Society Score. | 6 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Maria Middelares | Ghent | 9000 | Belgium | |||
| Royal London Hospital |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D001172 | Arthritis, Rheumatoid |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| 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. |
| Whitechapel |
| London |
| E11BB |
| United Kingdom |
| Royal National Orthopaedic Hospital NHS Trust | Stanmore | Middlesex | HA74LP | United Kingdom |
| The Elective Orthopaedic Centre (EOC) | Epsom | Surrey | KT18 7EG | United Kingdom |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |