Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty

  • STATUS
    Recruiting
  • End date
    Feb 16, 2024
  • participants needed
    100
  • sponsor
    Perth Hip and Knee
Updated on 17 February 2021

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 (FA TKA). Both FA TKA and MA TKA are performed through similar skin incisions, robotic-guidance, and use identical implants. In MA TKA, bone is prepared and implants positioned to ensure that that the overall alignment of the leg is in neutral. In FA TKA, the bone is prepared and implants positioned to restore the natural alignment of the patient's leg. Both of these surgical techniques provide excellent outcomes in TKA but it is not known which of the two techniques is better for patient recovery. Mako robotic-assisted TKA is an established treatment for arthritis of the knee joint. The positions of the implants and overall alignment of the leg are important as they influence how quickly the implants wear out and need replacing. The aim of this study is to determine if patient recovery is better with functionally aligned Mako robotic-assisted total knee arthroplasty (FA TKA) or mechanically aligned Mako robotic-assisted total knee arthroplasty (MA TKA)

Details
Condition Arthritis, Osteoarthritis, Arthritis and Arthritic Pain, Osteo Arthritis Knee, Arthritis and Arthritic Pain (Pediatric), degenerative arthritis
Treatment Functionally Aligned Total Knee Arthroplasty, Mechanically Aligned Total Knee Arthroplasty
Clinical Study IdentifierNCT04748510
SponsorPerth Hip and Knee
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

\- 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 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
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