A multi-centre, prospective randomised controlled trial to compare modified kinematically aligned total knee arthroplasty using iTKR™ Software with mechanically aligned total knee arthroplasty.
- Conditions
- Total Knee ArthroplastyOsteoarthritisMusculoskeletal - OsteoarthritisSurgery - Surgical techniques
- Registration Number
- ACTRN12618001376235
- Lead Sponsor
- Global Orthopaedic Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 102
Participants must meet the following criteria to be considered eligible to enrol into the study:
1.Be over the age of 18 years;
2.Be capable of understanding the study requirements and of providing informed consent
3.Be eligible for a primary total knee replacement base on history, physical examination and radiological evaluation –
4.Have primary diagnosis of Osteoarthritis of the knee
5.Agree to attend the research centre for the required post-operative assessments and radiological evaluation.
6.Pre-operative varus/valgus angle 15 degrees or less
Participants will be excluded from participating in the study if they meet any of the following exclusion criteria:
1.Not meeting the inclusion criteria.
2.BMI greater than 35
3.Haemoglobin A1c greater than 7
4.History of infection in the involved knee or current systemic infection
5.Previous fracture of the femur, tibia, patella or pelvis
6.Previous osteotomy of the affected knee
7.Previous ACL damage or repair
8.Not medically cleared to undergo a total knee replacement
9.American Society of Anaesthesiologists rating of 4 or greater
10.Life expectancy of less than 6 months from all causes
11.Workers Compensation patient
12.Preoperative knee in greater than 15 degrees of varus or valgus
13.Ligamentous laxity of the knee requiring a higher level constrained prosthesis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method