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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
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
Assessment of the clinical outcome following total knee replacement using the Knee Society Score.
Time frame: 6 months
The OXFORD score as a measure of implant functionality.
Time frame: pre-op, 6 months and annually for 10 years
Assessment of implant survivorship as a measure of safety and tolerability.
Time frame: 6 weeks, 6 months, 3, 5, 7 and 10 years.
Radiographic analysis
Time frame: pre-op, 6 months, 3, 5,7 and 10 years.
The EuroQol score as a measure of patient' quality of life.
Time frame: pre-op, 6 months, 3, 5,7 and 10 years
Assessment of the clinical outcome following total knee replacement using the Knee Society Score
Time frame: pre-op, at 6 months, at 3, 5, 7 and 10 years.
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