ACTRN12618001376235Recruiting未知
A multi-centre, prospective randomised controlled trial to compare outcomes following modified kinematically aligned total knee arthroplasty using iTKR™ Software with those following mechanically aligned total knee arthroplasty.
Global Orthopaedic Technology0 sites102 target enrollmentStarted: August 16, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 102
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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