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

Primary Purpose

Osteoarthritis, Osteo Arthritis Knee

Status

Recruiting

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Functionally Aligned Total Knee Arthroplasty

Mechanically Aligned Total Knee Arthroplasty

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring OA, Arthritis, Knee, Osteoarthritis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Perth Hip and KneeRecruiting
St John of God Private Hopsital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Functionally aligned Total Knee Arthroplasty

Mechanical axis aligned Total Knee Arthroplasty

Arm Description

Knee arthroplasty performed using a functional alignment theory

Knee arthroplasty performed using a mechanical alignment theory

Outcomes

Primary Outcome Measures

Difference in Forgotten Joint Score after 2 years

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

Difference in Oxford Knee Score after 2 years

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.

Relative change in range of motion between FA and MA patients post-operatively compared to preoperatively.

Difference in range of motion via goniometry preoperatively and postoperatively at 2 years

Secondary Outcome Measures

Determine lower limb alignment achieved with both alignment techniques

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.

Difference in analgesia requirements between patients in alignment groups

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

Difference in sagittal stability of the knee post replacement

Determine whether alignment method utilized has an effect on the sagittal stability of the knee post replacement, as measure with an arthrometer "Lachmeter"

Difference in functional outcomes (measured as maximal voluntary contraction) of knee flexion and extension between alignment groups

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.

Intra-operative balance achieved with different alignment techniques.

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)

Difference in clinical outcomes as measured in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement Score (KoosJR)

Difference in operated knee outcome on Koos JR scale. Scale 0-100 where higher scores mean better outcome.

Difference in clinical outcomes as measured in European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D-5L).

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.

Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS)

Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS). Scale 0-100 with higher scores meaning worse outcome.

Difference in clinical outcomes as measured by Kujala score- a measure of anterior knee pain and best clinical score for patellofemoral function

Difference in clinical outcomes as measured by Kujala score. Scale 0-100 with higher scores meaning better outcome.

Full Information

NCT ID

NCT04748510

First Posted

February 4, 2021

Last Updated

April 28, 2022

Sponsor

Perth Hip and Knee

Collaborators

St John of God Private Hospital Subiaco

1. Study Identification

Unique Protocol Identification Number

NCT04748510

Brief Title

Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty

Acronym

FATKAvsMATKA

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 30, 2021 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Perth Hip and Knee

Collaborators

St John of God Private Hospital Subiaco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Osteo Arthritis Knee

Keywords

OA, Arthritis, Knee, Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Functionally aligned Total Knee Arthroplasty

Arm Type

Active Comparator

Arm Description

Knee arthroplasty performed using a functional alignment theory

Arm Title

Mechanical axis aligned Total Knee Arthroplasty

Arm Type

Active Comparator

Arm Description

Knee arthroplasty performed using a mechanical alignment theory

Intervention Type

Procedure

Intervention Name(s)

Functionally Aligned Total Knee Arthroplasty

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Mechanically Aligned Total Knee Arthroplasty

Intervention Description

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 Measure Information:

Title

Difference in Forgotten Joint Score after 2 years

Description

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

Time Frame

Preoperatively and 2 years postoperatively

Title

Difference in Oxford Knee Score after 2 years

Description

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.

Time Frame

Preoperatively and 2 years postoperatively

Title

Relative change in range of motion between FA and MA patients post-operatively compared to preoperatively.

Description

Difference in range of motion via goniometry preoperatively and postoperatively at 2 years

Time Frame

Preoperatively and 2 years postoperatively

Secondary Outcome Measure Information:

Title

Determine lower limb alignment achieved with both alignment techniques

Description

Time Frame

3 Months post-operatively

Title

Difference in analgesia requirements between patients in alignment groups

Description

Time Frame

6 weeks, 3 months, 1 year, 2 years

Title

Difference in sagittal stability of the knee post replacement

Description

Determine whether alignment method utilized has an effect on the sagittal stability of the knee post replacement, as measure with an arthrometer "Lachmeter"

Time Frame

Preop, and post-operatively at 3 months, 1 year and 2 years

Title

Difference in functional outcomes (measured as maximal voluntary contraction) of knee flexion and extension between alignment groups

Description

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.

Time Frame

Preop, 3 months, 1 Year and 2 years

Title

Intra-operative balance achieved with different alignment techniques.

Description

Time Frame

Intraoperatively

Title

Difference in clinical outcomes as measured in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement Score (KoosJR)

Description

Difference in operated knee outcome on Koos JR scale. Scale 0-100 where higher scores mean better outcome.

Time Frame

Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.

Title

Difference in clinical outcomes as measured in European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D-5L).

Description

Time Frame

Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.

Title

Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS)

Description

Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS). Scale 0-100 with higher scores meaning worse outcome.

Time Frame

Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.

Title

Difference in clinical outcomes as measured by Kujala score- a measure of anterior knee pain and best clinical score for patellofemoral function

Description

Difference in clinical outcomes as measured by Kujala score. Scale 0-100 with higher scores meaning better outcome.

Time Frame

Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gavin Clark

Phone

+61864891777

clark@hipnknee.com.au

First Name & Middle Initial & Last Name or Official Title & Degree

Beth L Tippett

beth@hipnknee.com.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gavin Clark

Organizational Affiliation

Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Perth Hip and Knee

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gavin Clark

Phone

+61864891777

clark@hipnknee.com.au

First Name & Middle Initial & Last Name & Degree

Beth Tippett

Phone

+61 8 6489 1777

beth@hipnknee.com.au

First Name & Middle Initial & Last Name & Degree

Dermot Collopy

First Name & Middle Initial & Last Name & Degree

Gavin Clark

Facility Name

St John of God Private Hopsital

City

Subiaco

State/Province

ZIP/Postal Code

6008

Country

Australia

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Not shared - for confidentiality of participants

Citations:

PubMed Identifier

34372888

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.

Results Reference

derived

Learn more about this trial

Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty

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