Clinical trial NCT04748510: Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty
Official title: A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment With Mechanical Axis Alignment on Outcomes After Total Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Osteo Arthritis Knee
Keywords: OA
Arthritis
Knee
Osteoarthritis
Lead sponsor: Perth Hip and Knee
Sponsor class: OTHER
Collaborators: name: St John of God Private Hospital Subiaco
First posted: 2021-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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)


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in Forgotten Joint Score after 2 years
timeFrame: Preoperatively and 2 years postoperatively
measure: Difference in Oxford Knee Score after 2 years
timeFrame: Preoperatively and 2 years postoperatively
measure: Relative change in range of motion between FA and MA patients post-operatively compared to preoperatively.
timeFrame: Preoperatively and 2 years postoperatively
Secondary outcomes:
measure: Determine lower limb alignment achieved with both alignment techniques
timeFrame: 3 Months post-operatively
measure: Difference in analgesia requirements between patients in alignment groups
timeFrame: 6 weeks, 3 months, 1 year, 2 years
measure: Difference in sagittal stability of the knee post replacement
timeFrame: Preop, and post-operatively at 3 months, 1 year and 2 years
measure: Difference in functional outcomes (measured as maximal voluntary contraction) of knee flexion and extension between alignment groups
timeFrame: Preop, 3 months, 1 Year and 2 years
measure: Intra-operative balance achieved with different alignment techniques.
timeFrame: Intraoperatively
measure: Difference in clinical outcomes as measured in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement Score (KoosJR)
timeFrame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
measure: Difference in clinical outcomes as measured in European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D-5L).
timeFrame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
measure: Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS)
timeFrame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
measure: Difference in clinical outcomes as measured by Kujala score- a measure of anterior knee pain and best clinical score for patellofemoral function
timeFrame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
Other outcomes:
Locations:
city: Subiaco
country: Australia
facility: Perth Hip and Knee
state: Western Australia
city: Subiaco
country: Australia
facility: St John of God Private Hopsital
state: W
Study officials:
affiliation: Principal Investigator
name: Gavin Clark
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steer R, Tippett B, Khan RN, Collopy D, Clark G. A prospective randomised control trial comparing functional with mechanical axis alignment in total knee arthroplasty: study protocol for an investigator initiated trial. Trials. 2021 Aug 9;22(1):523. doi: 10.1186/s13063-021-05433-z.