None listed
Conditions
Brief summary
The GMK® SpheriKA is a total knee replacement device developed by Medacta International SA as a product line extension of the GMK® Sphere femoral component (class III CE marked). GMK® Sphere has been on the market since 2011. The design of the SpheriKA femoral components is optimized for the kinematic alignment technique, with particular focus on those cases when the position of the femoral component may represent a challenge for the patella tracking. The purpose of the study is to assess the clinical effectiveness and survivorship of the GMK SpheriKA device. This will be achieved by; evaluating patient reported outcome measures (PROMs), clinical outcomes, radiological outcomes and survivorship. Medacta may use the results of this project in their application to the Prosthesis List Advisory Committee (PLAC) for assessment. The GMK SpheriKA is not yet listed on “the Prosthesis List”. A patient reported outcome measure (PROM) is defined as any report of a patient’s health status that comes directly from the patient without the interpretation by others. Incorporating PROMs not only enables the inclusion of this unique and critically important perspective of the patient’s opinion, but also broadens the range of outcomes that can be evaluated. With specific regard to joint replacement, PROMS can provide meaningful information on the extend of pain and disability prior to surgery, as well as the extent and timing of recovery and the presence of complications. The successful collection, knowledgeable interpretation and integration of PROMs with other outcomes can improve the benefit and cost effectiveness of health care delivery. The hypothesis is that the 2-year survivorship for the GMK SpheriKA knee system is not inferior to the survivorship rate of the other medial pivot knee designs.
Interventions
The GMK® SpheriKA is a total knee replacement (TKR) device developed by Medacta International SA as a product line extension of the GMK® Sphere femoral component (class III CE-marked). GMK® Sphere has been on the market since 2011. The design of the SpheriKA femoral components is optimized for the kinematic alignment technique, with particular focus on those cases when the position of the femoral component may represent a challenge for the patella tracking.The duration of the procedure will take
The GMK® SpheriKA is a total knee replacement (TKR) device developed by Medacta International SA as a product line extension of the GMK® Sphere femoral component (class III CE-marked). GMK® Sphere has been on the market since 2011. The design of the SpheriKA femoral components is optimized for the kinematic alignment technique, with particular focus on those cases when the position of the femoral component may represent a challenge for the patella tracking.The duration of the procedure will take approximately 1-1.5 hours, as per a standard TKR. The aim of the study is to evaluate patient reported outcome measures, clinical outcomes, radiological outcomes, and survivorship of the GMK SpheriKA device up to 10 years post-operative. All observational participant data will be collected into an existing electronic App (Patient Optimized Pathway) as per standard protocol. Several patient reported outcome measures (PROMS) in the form of questionnaires, will be collected and analysed during the pre-operative visit and again at 6 months, 1 year, 2 years, 5 years and 10 years timepoints post-procedure. The questionnaires should take up to 30 minutes for the participants to complete. Adherence to the intervention will be monitored through ongoing reviews by the independent expert data safety monitoring board (DSMB). The reviews will include the assessment of the results and any adverse events from the study.
Sponsors
Medacta Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• Patients undergoing a primary total knee replacement according to the indications for use (On-Label use). • Patients with intact collateral ligaments • Patients ability to use a mobile phone app to answer the questionnaires
Exclusion criteria
• Patients with inflammatory arthritis. • BMI >40 • Patients with a history of total or unicompartmental reconstruction of the affected joint. • Patients that have had a high tibial osteotomy or femoral osteotomy. • Patients with neuromuscular or neurosensory deficiency, • Patients with bad chronic disease • Previous instability of patello-femoral joint/previous surgery for patello-femoral stabilisation • Patients that are immunologically compromised • Patients presenting with emergency procedures • Patients with an intellectual or physical disability preventing them from using the APP. • Patients that do not own a smart phone or device will need to be excluded from the study.
Outcome results
None listed