None listed
Conditions
Brief summary
This is an observational study to assess the clinical utility of new methods of displaying information collected during computer-assisted primary total hip replacement surgery used to treat patients with osteoarthritis. The position of the leg will be displayed, measured and recorded at various stages in the procedure. This information will be used to decide upon future improvements in software with the aim of providing surgeons with better guidance on the optimal position of hip replacement components.
Interventions
Candidates in the study will be selected from a pool of patients undergoing total hip replacement using computer assisted surgery as standard of care. Additional observations will be made during the procedure resulting in the standard operating time (typically 1-2 hours) being extended by approximately 10 minutes. Patients will only be observed during the joint replacement surgery with no post-operative follow-ups included. The total duration of this observation study will be 12 months including
Candidates in the study will be selected from a pool of patients undergoing total hip replacement using computer assisted surgery as standard of care. Additional observations will be made during the procedure resulting in the standard operating time (typically 1-2 hours) being extended by approximately 10 minutes. Patients will only be observed during the joint replacement surgery with no post-operative follow-ups included. The total duration of this observation study will be 12 months including patient recruitment.
Sponsors
Stryker Australia
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is a candidate for primary total hip replacement using computer navigation. 2. Patient has a primary diagnosis of osteoarthritis, rheumatoid arthritis or avascular necrosis. 3. Patient is a male or non-pregnant female patient age 18 to 90. 4. Patient has signed a Human Research Ethics Committee (HREC)-approved, study specific Information Patient Consent Form.
Exclusion criteria
1. Patient has abnormal pelvic anatomy (previous fracture, osteotomy or development dysplasia). 2. Patient is morbidly obese (Body Mass Index, BMI >= 40). 3. Patient has an existing condition where increasing surgical time may be detrimental to the patient. 4. Patient has a cognitive impairment, an intellectual disability or a mental illness.
Outcome results
None listed