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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04748510




Registration number
NCT04748510
Ethics application status
Date submitted
4/02/2021
Date registered
10/02/2021
Date last updated
29/04/2022

Titles & IDs
Public title
Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty
Scientific title
A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment With Mechanical Axis Alignment on Outcomes After Total Knee Arthroplasty.
Secondary ID [1] 0 0
ACTRN12621000060842
Universal Trial Number (UTN)
Trial acronym
FATKAvsMATKA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Osteo Arthritis Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Functionally Aligned Total Knee Arthroplasty
Treatment: Surgery - Mechanically Aligned Total Knee Arthroplasty

Active comparator: Functionally aligned Total Knee Arthroplasty - Knee arthroplasty performed using a functional alignment theory

Active comparator: Mechanical axis aligned Total Knee Arthroplasty - Knee arthroplasty performed using a mechanical alignment theory


Treatment: Surgery: 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.

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in Forgotten Joint Score after 2 years
Timepoint [1] 0 0
Preoperatively and 2 years postoperatively
Primary outcome [2] 0 0
Difference in Oxford Knee Score after 2 years
Timepoint [2] 0 0
Preoperatively and 2 years postoperatively
Primary outcome [3] 0 0
Relative change in range of motion between FA and MA patients post-operatively compared to preoperatively.
Timepoint [3] 0 0
Preoperatively and 2 years postoperatively
Secondary outcome [1] 0 0
Determine lower limb alignment achieved with both alignment techniques
Timepoint [1] 0 0
3 Months post-operatively
Secondary outcome [2] 0 0
Difference in analgesia requirements between patients in alignment groups
Timepoint [2] 0 0
6 weeks, 3 months, 1 year, 2 years
Secondary outcome [3] 0 0
Difference in sagittal stability of the knee post replacement
Timepoint [3] 0 0
Preop, and post-operatively at 3 months, 1 year and 2 years
Secondary outcome [4] 0 0
Difference in functional outcomes (measured as maximal voluntary contraction) of knee flexion and extension between alignment groups
Timepoint [4] 0 0
Preop, 3 months, 1 Year and 2 years
Secondary outcome [5] 0 0
Intra-operative balance achieved with different alignment techniques.
Timepoint [5] 0 0
Intraoperatively
Secondary outcome [6] 0 0
Difference in clinical outcomes as measured in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement Score (KoosJR)
Timepoint [6] 0 0
Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
Secondary outcome [7] 0 0
Difference in clinical outcomes as measured in European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D-5L).
Timepoint [7] 0 0
Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
Secondary outcome [8] 0 0
Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS)
Timepoint [8] 0 0
Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
Secondary outcome [9] 0 0
Difference in clinical outcomes as measured by Kujala score- a measure of anterior knee pain and best clinical score for patellofemoral function
Timepoint [9] 0 0
Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.

Eligibility
Key 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
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,
Recruitment hospital [1] 0 0
Perth Hip and Knee - Subiaco
Recruitment hospital [2] 0 0
St John of God Private Hopsital - Subiaco
Recruitment postcode(s) [1] 0 0
6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Other
Name
Perth Hip and Knee
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St John of God Private Hospital Subiaco
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/study/NCT04748510
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Gavin Clark
Address 0 0
Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gavin Clark
Address 0 0
Country 0 0
Phone 0 0
+61864891777
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04748510