None listed
Conditions
Brief summary
This study assesses the clinical performance of implants used to treat osteoarthritis using total knee replacement. Highly-accurate X-rays will be used to measure any small motions of the implant components at regular intervals after the knee replacement operation. The health status of patients and ability for them to perform activities of daily living will also be measured. This information will be used to confirm that new methods of securing the knee replacement components to the bone are clinically effective.
Interventions
Total knee arthroplasty will be performed using a traditional medial parapatellar approach. Distal femur and proximal tibia resections will be completed using intramedullary alignments jigs. Implantation of the femoral and tibial tray components will be performed without the use of bone cement. The approximate duration of the procedure is 90-120 minutes. Micromotion of the implanted components will be assessed by X-ray, using the pre-weight-bearing position as the base for subsequent measurement
Total knee arthroplasty will be performed using a traditional medial parapatellar approach. Distal femur and proximal tibia resections will be completed using intramedullary alignments jigs. Implantation of the femoral and tibial tray components will be performed without the use of bone cement. The approximate duration of the procedure is 90-120 minutes. Micromotion of the implanted components will be assessed by X-ray, using the pre-weight-bearing position as the base for subsequent measurements.
Sponsors
Stryker Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Symptomatic osteoarthritis of the knee requiring intervention. 2. Between the ages of 21 and 80 years inclusive. 3. Ability to give informed consent.
Exclusion criteria
1. Significant co-morbidity affecting ability to ambulate 2. Flexion contracture greater than 15 degrees 3. Extension lag greater than 10 degrees 4. Tibial subluxation greater than 10mm on standing radiograph 5. Prior arthroplasty, patellectomy or osteotomy with the affected knee 6. Lateral or medial collateral ligament instability (>10 degrees varus/valgus) 7. Leg length discrepancy greater than 10mm 8. Active or prior infection 9. Morbid obesity (Body Mass Index, BMI > 40) 10. Medical condition precluding major surgery 11. Severe osteoporosis or osteopenia 12 Neuromuscular impairment
Outcome results
None listed