Status:
COMPLETED
Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty
Lead Sponsor:
Perth Hip and Knee
Collaborating Sponsors:
St John of God Private Hospital Subiaco
Conditions:
Osteoarthritis
Osteo Arthritis Knee
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
The objective of this study is to compare clinical and radiological outcomes in robotic-arm assisted TKA using mechanical alignment (MA TKA) versus robotic-arm assisted TKA with functional alignment (...
Detailed Description
This project is being conducted by Perth Hip and Knee Clinic. The objective of this study is to compare clinical and radiological outcomes in robotic-arm assisted TKA using mechanical alignment (MA TK...
Eligibility Criteria
Inclusion
- 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 therapies 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
Exclusion
- 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 Posterior Cruciate Ligament to be released. These patients will be still included in the study, but analyzed with an intention-to-treat principle.
- Patient has bone loss that requires augmentation
- Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA (e.g., 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 in 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 (e.g., Dementia)
- Patient is unable to communicate effectively in English.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04748510
Start Date
April 30 2021
End Date
November 14 2024
Last Update
August 8 2025
Active Locations (2)
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1
Perth Hip and Knee
Subiaco, Western Australia, Australia, 6008
2
St John of God Private Hopsital
Subiaco, Western Australia, Australia, 6008