A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment with Mechanical Axis Alignment on Outcomes after Total Knee Arthroplasty.
- Conditions
- OsteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12621000060842
- Lead Sponsor
- Gavin Clark
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 100
Patient has symptomatic knee osteoarthritis requiring primary TKA
-Patient and surgeon are in agreement that TKA is the most appropriate treatment
-Patient is fit for surgical intervention following review by surgeon
-Patient is between 45-75 years of age at time of surgery, computer literate, and able to complete patient reported outcome measures independently.
-Patient must be capable of giving informed consent and agree to comply with the postoperative review program.
-Patient must be a permanent resident in an area accessible to the study site
-Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken
-Patient has tried non-pharmacologic therapy’s including ; patient education, self-management programs, aerobic exercise, weight loss, physiotherapy and occupational therapy
-Patient has tried appropriate pharmacologic therapies including ; regular paracetamol and NSAIDS if appropriate
- Patient is not suitable for routine primary TKA. E.g. patient has ligament deficiency that requires a constrained prosthesis
- Interoperative requirement for a more constrained implant.
- Intraoperative requirement for the PCL to be released. These patients will be still included in the study, but analyzed with an intention to treat principal.
- Patient has bone loss that requires augmentation
- Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA (eg. Post high tibial or distal femoral osteotomy)
- Patient requires a polyethylene inset of 13mm or greater.
- Patient is immobile or has another neurological condition affecting musculoskeletal function
- Patient is less than 44 years of age or greater than 76 years of age
- Patient is a compensable patient. I.e. Worker’s compensation claim or motor vehicle accident.
- Patient is already enrolled on another concurrent clinical trial
- Patient is unable or unwilling to sign the informed consent form specific to this study
- Patient is unable to attend the follow-up program
- Patient is non-resident in local area or expected to leave the catchment area postoperatively
- Patients who lacks capacity to provide consent, or the ability to understand the study protocol due to a cognitive condition (eg. Dementia)
- Patient is unable to communicate effectively in English.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method