None listed
Conditions
Brief summary
This is a prospective, international multi-centre clinical study. The study will enrol a minimum of 1000 patients over a 36 month recruitment period between approximately 25 surgeons at 30 centres in Australia and New Zealand. The objectives of the study are: * To evaluate the clinical outcomes of the Saiph Total Knee Replacement and ensure that it performs as intended. * To compare the results of this study to the optimal clinical results of the design surgeons to ensure their results can be reproduced. The Saiph Total Knee Replacement (TKR) is intended for use as a primary total knee replacement device consisting of a femoral, tibial, tibial bearing and optional patellar component. The Saiph TKR is CE marked, TGA approved and has a rebate code on the Prostheses List. Clinical evaluations: Standard, functional parameters such as range of motion will be assessed preoperatively, and postoperatively at 6 weeks and at 6/12 months. Further clinical evaluations at 2 years and 5 years will be collected only for those patients that return to clinic for this review. Patient outcome assessments: The KOOS (Full Version), Oxford Knee Score (OKS), EQ5D and UCLA Activity Scale will be assessed preoperatively, and postoperatively at 6/12 months, 2 years and 5 years. Radiographic evaluations: Anterior and lateral X-rays will be analysed preoperatively, immediately postoperatively and at standard of care time points thereafter.
Interventions
Patients will be consented to be included into the study. The patient will undergo total knee replacement surgery and receive a Saiph Total Knee Replacement which is a cemented implant that evolved from the successful Freeman-Samuelson principles. The operation will take approximately 1.5 hours and will be performed by the consultant orthopaedic surgeon with experience of implanting the Saiph Knee. The Saiph Knee is a TGA approved product and is used by many orthopaedic surgeons in Australia
Patients will be consented to be included into the study. The patient will undergo total knee replacement surgery and receive a Saiph Total Knee Replacement which is a cemented implant that evolved from the successful Freeman-Samuelson principles. The operation will take approximately 1.5 hours and will be performed by the consultant orthopaedic surgeon with experience of implanting the Saiph Knee. The Saiph Knee is a TGA approved product and is used by many orthopaedic surgeons in Australia and New Zealand.
Sponsors
MatOrtho Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients requiring a primary knee replacement as determined jointly by the surgeon and the patient 2. Over 18 years of age at time of surgery 3. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up 4. Patients who are capable of, and have given, informed consent to their participation in the study
Exclusion criteria
1. Pregnant females or those planning on becoming pregnant during follow-up period 2. Patients with no pre-operative data and questionnaires 3. Patients with active local or systemic infection, severe osteoporosis or severe neurological, vascular or muscular compromise such that knee replacement is inappropriate. 4. Patients with severe bone loss or collateral ligament instability 5. Workers compensation patients
Outcome results
None listed