Arthritis, Avascular Necrosis, Poly-arthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Brief 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.
Interventions
DEVICEGMK Sphere Knee Replacement
Sponsors
Medacta International SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the clinical outcome following total knee replacement using the Knee Society Score. | 6 months |
Secondary
| Measure | 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. |
Countries
Belgium, United Kingdom
Outcome results
None listed