Determining the clinical utility of the NextAR navigation system in providing soft tissue balance pattern data during total knee replacement surgery, to enable prosthesis implants to resemble more native knee alignment and thereby improve patient outcomes.
Not Applicable
Recruiting
- Conditions
- Knee OsteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12619001635156
- Lead Sponsor
- Medacta Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Patients with end-stage osteoarthritis of the knee suitable for total knee arthroplasty
- Aged over 18 years
Exclusion Criteria
- Patients unsuitable for total knee replacement due to chronic infection, medical disease, inability to consent, inability to attend post-operative follow-up appointments, significant psychiatric issues, substance abuse issues.
- Previous reconstructive/fracture/arthroplasty surgery on affected knee
-Active inflammation arthropathy
- Significant extra articular deformity
- Morbidly Obese (BMI>40)
- Pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-year self-reported joint replacement awareness scores as measured using The Forgotten Joint Score Questionnaire.[ Two-years post-surgery]
- Secondary Outcome Measures
Name Time Method To assess clinical outcomes as measured by scores obtained following the completion of the Oxford Knee Questionnaire at two-years.[ Two years post-surgery];To assess clinical outcomes as measured by scores obtained following the completion of the International Knee Documentation Committee (IKDC) Questionnaire at two-years.[ Two-years post-surgery.];To assess clinical outcomes as measured by scores obtained following the completion of the EQ-5D Questionnaire at two-years.[ Two-years post-surgery]