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Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty (FATKAvsMATKA)

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ClinicalTrials.gov Identifier: NCT04748510
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
St John of God Private Hospital Subiaco
Information provided by (Responsible Party):
Gavin Clark, Perth Hip and Knee

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)

Condition or disease Intervention/treatment Phase
Osteoarthritis Osteo Arthritis Knee Procedure: Functionally Aligned Total Knee Arthroplasty Procedure: Mechanically Aligned Total Knee Arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment With Mechanical Axis Alignment on Outcomes After Total Knee Arthroplasty.
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Functionally aligned Total Knee Arthroplasty
Knee arthroplasty performed using a functional alignment theory
Procedure: Functionally Aligned Total Knee Arthroplasty
Femoral + tibial osteotomy planned for equal resection of femoral condyles to replicate patient anatomy. In coronal plane, distal femoral resection of 6.5mm subchondral bone from medial + lateral condyles, adjusted 1-3mm for compensation of wear. Proximal tibia, 7mm resection from subchondral bone from medial + lateral tibial plateau. Sagittal plane, resection angle determined intraoperatively to closely match native femoral flexion + tibial slope. Axial plane: posterior femoral resection 6.5mm from the subchondral bone of medial and lateral posterior condyles. Tibial rotation aligned to Akagi's line. Adjustments will be made to bony alignment to balance soft tissues within boundaries of 6° varus/3° valgus HKA alignment. Femoral component alignment limited to 6° valgus/3° varus in coronal plane. Tibial alignment limited 6° varus/3° valgus in coronal plane. Combined flexion of components limited to 10° flexion. Soft tissue release if balance within boundaries not achieved.

Active Comparator: Mechanical axis aligned Total Knee Arthroplasty
Knee arthroplasty performed using a mechanical alignment theory
Procedure: Mechanically Aligned Total Knee Arthroplasty
Tibial and femoral osteotomies in the coronal plane will be planned perpendicular to the tibial and femoral mechanical axes respectively to achieve neutral overall alignment. Soft tissue balance will be assessed and minor adjustments to bony alignment made to balance the knees with a maximal adjustment of two degrees valgus and two degrees varus of coronal alignment from neutral. Femoral rotation will be planned to surgical epicondylar axis and adjustments to rotation made to allow equal flexion and extension balance (to within 1mm). If balance can not be achieved within these boundaries then soft tissue release will be undertaken. In the sagittal plane, 0-3° degrees of posterior tibial slope and 0-5° of femoral component flexion will be used to optimise implant sizing whilst preventing notching. In the axial plane, the tibial component aligned to Akagi's line, which connects the medial border of the patellar tendon attachment to the middle of the posterior cruciate ligament.




Primary Outcome Measures :
  1. Difference in Forgotten Joint Score after 2 years [ Time Frame: Preoperatively and 2 years postoperatively ]
    Difference in relative change in Forgotten joint score between FA and MA patients 2 years post-operatively compared to preoperatively. Scale 0-100 with higher scores being a better outcome

  2. Difference in Oxford Knee Score after 2 years [ Time Frame: Preoperatively and 2 years postoperatively ]
    Difference in relative change in Oxford Knee Score (OKS) between FA and MA patients 2 years post-operatively compared to preoperatively. Scale 0-48 with higher scores being a better outcome.

  3. Relative change in range of motion between FA and MA patients post-operatively compared to preoperatively. [ Time Frame: Preoperatively and 2 years postoperatively ]
    Difference in range of motion via goniometry preoperatively and postoperatively at 2 years


Secondary Outcome Measures :
  1. Determine lower limb alignment achieved with both alignment techniques [ Time Frame: 3 Months post-operatively ]
    Lower limb alignment as assessed using standing long leg x-rays performed postoperatively at 3 months. Measurements of the hip-knee-angle (HKA), medial proximal tibial angle (MPTA) and lateral distal femoral angle (LDFA). Also evidence of imbalance with implant lift off will be measured.

  2. Difference in analgesia requirements between patients in alignment groups [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ]

    Determine if there are any differences in analgesic requirements based on alignment method used.

    Inpatient medical records will be utilised to obtain analgesia requirements as inpatient Questionnaires will be used to obtain analgesia usage at remaining timepoints. Analgesia usage will be converted to morphine equivalent dosages for comparison


  3. Difference in sagittal stability of the knee post replacement [ Time Frame: Preop, and post-operatively at 3 months, 1 year and 2 years ]
    Determine whether alignment method utilized has an effect on the sagittal stability of the knee post replacement, as measure with an arthrometer "Lachmeter"

  4. Difference in functional outcomes (measured as maximal voluntary contraction) of knee flexion and extension between alignment groups [ Time Frame: Preop, 3 months, 1 Year and 2 years ]

    Determine whether alignment method utilized has an effect on functional outcomes.

    Measured as Maximal voluntary isometric knee flexion and extension forces as measured via hand-held dynamometry.


  5. Intra-operative balance achieved with different alignment techniques. [ Time Frame: Intraoperatively ]
    Surgeon blinded measurement of intraoperative balance achieved with Verasense sensor (smaller cohort) Secondary outcome [6] To determine if there is a difference in knee kinematics between the two techniques. Measurement of knee kinematics with Verasense sensor to assess presence or absence of medial pivot (smaller cohort)

  6. Difference in clinical outcomes as measured in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement Score (KoosJR) [ Time Frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. ]
    Difference in operated knee outcome on Koos JR scale. Scale 0-100 where higher scores mean better outcome.

  7. Difference in clinical outcomes as measured in European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D-5L). [ Time Frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. ]
    Difference in overall by Visual Analogue Scale for overall health (VAS). Scale: Five dimensions combined into a 5-digit number lower numbers represent better outcomes. Addition of overall health VAS Scale 0-100 with higher score being better outcome.

  8. Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS) [ Time Frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. ]
    Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS). Scale 0-100 with higher scores meaning worse outcome.

  9. Difference in clinical outcomes as measured by Kujala score- a measure of anterior knee pain and best clinical score for patellofemoral function [ Time Frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. ]
    Difference in clinical outcomes as measured by Kujala score. Scale 0-100 with higher scores meaning better outcome.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748510


Contacts
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Contact: Gavin Clark +61864891777 clark@hipnknee.com.au
Contact: Beth L Tippett beth@hipnknee.com.au

Locations
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Australia, Western Australia
Perth Hip and Knee Recruiting
Subiaco, Western Australia, Australia, 6008
Contact: Gavin Clark    +61864891777    clark@hipnknee.com.au   
Contact: Beth Tippett    +61 8 6489 1777    beth@hipnknee.com.au   
Sub-Investigator: Dermot Collopy         
Principal Investigator: Gavin Clark         
Australia, W
St John of God Private Hopsital Active, not recruiting
Subiaco, W, Australia, 6008
Sponsors and Collaborators
Perth Hip and Knee
St John of God Private Hospital Subiaco
Investigators
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Principal Investigator: Gavin Clark Principal Investigator
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Responsible Party: Gavin Clark, Principal investigator, Perth Hip and Knee
ClinicalTrials.gov Identifier: NCT04748510    
Other Study ID Numbers: ACTRN12621000060842
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not shared - for confidentiality of participants

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gavin Clark, Perth Hip and Knee:
OA
Arthritis
Knee
Osteoarthritis
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases