OsteoarthritisFATKAvsMATKANCT04748510
Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty
A study testing Functionally Aligned Total Knee Arthroplasty and Mechanically Aligned Total Knee Arthroplasty in people with Osteoarthritis and Osteo Arthritis Knee, run by Perth Hip and Knee at 2 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis, Osteo Arthritis Knee
- What is being tested?
- Functionally Aligned Total Knee Arthroplasty and Mechanically Aligned Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesAustralia
- Study dates
- 30 Apr 2021to 14 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken
- Patient has tried non-pharmacologic therapies 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
Who cannot join
- 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 principle.
- Patient has bone loss that requires augmentation
- Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA (e.g., post-high tibial or distal femoral osteotomy)
- Patient requires a polyethylene inset of 13mm or greater.
Show all 15Show fewer
- 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 in 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 (e.g., Dementia)
- Patient is unable to communicate effectively in English.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Perth Hip and Knee
Subiaco, Western Australia, 6008
St John of God Private Hopsital
Subiaco, Western Australia, 6008
About this study
Official title: A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment With Mechanical Axis Alignment on Outcomes After Total Knee Arthroplasty.
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).
These outcomes will be used 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).
Read the detailed description
This project is being conducted by Perth Hip and Knee Clinic. 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 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).
- Conditions
- Osteoarthritis, Osteo Arthritis Knee
- Being tested
- Functionally Aligned Total Knee Arthroplasty, Mechanically Aligned Total Knee Arthroplasty
- Keywords
- OA, Arthritis, Knee, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functionally Aligned Total Knee ArthroplastyProcedure or surgery
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.
Mechanically Aligned Total Knee ArthroplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Functionally aligned Total Knee Arthroplasty | Active comparator | Knee arthroplasty performed using a functional alignment theory Receives: Procedure: Functionally Aligned Total Knee Arthroplasty |
| Mechanical axis aligned Total Knee Arthroplasty | Active comparator | Knee arthroplasty performed using a mechanical alignment theory Receives: Procedure: Mechanically Aligned Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forgotten Joint Score After 2 Years From Baseline
Difference in relative change in Forgotten Joint Score (2 years post-operatively compared to preoperatively) between FA and MA patients. Scale 0-100 with higher scores being a better outcome
Measured: Preoperatively and 2 years postoperatively
Change in Oxford Knee Score After 2 Years From Baseline
Difference in relative change in Oxford Knee Score (2 years post-operatively compared to preoperatively) between FA and MA patients. Scale 0-48 with higher scores being a better outcome.
Measured: Preoperatively and 2 years postoperatively
Change in Range of Motion After 2 Years From Baseline
Difference in relative change in range of motion via goniometry (2 years post-operatively compared to preoperatively) between FA and MA patients.
Measured: Preoperatively and 2 years postoperatively
Secondary outcomes (9)
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.
Measured: 3 Months post-operatively
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
Measured: 6 weeks, 3 months, 1 year, 2 years
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"
Measured: Preop, and post-operatively at 3 months, 1 year and 2 years
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.
Measured: Preop, 3 months, 1 Year and 2 years
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)
Measured: Intraoperatively
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 between FA and MA patients. Scale 0-100 where higher scores mean better outcome.
Measured: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
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.
Measured: 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)
Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS). Scale 0-100 with higher scores meaning worse outcome.
Measured: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
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 between FA and MA patients. Scale 0-100, with higher scores indicating better outcome.
Measured: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start30 Apr 2021
- Primary completion8 Oct 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perth Hip and Knee
- Sponsor type
- University, hospital or other
- Collaborators
- St John of God Private Hospital Subiaco
- Responsible party
- Principal investigator, Gavin Clark, Perth Hip and Knee
- Investigators
- Gavin Clark, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748510
- Sponsor's protocol ID
- ACTRN12621000060842
- Acronym
- FATKAvsMATKA
- Status last verified
- Jul 2025
- First submitted
- 4 Feb 2021
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not shared - for confidentiality of participants
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.
PubMed 34372888
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment With Mechanical Axis Alignment on Outcomes After Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT04748510
- Acronym / sponsor ID
- FATKAvsMATKA / ACTRN12621000060842
- Conditions
- Osteoarthritis, Osteo Arthritis Knee
- Keywords
- OA, Arthritis, Knee, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Perth Hip and KneeUniversity, hospital or other
- Collaborators
- St John of God Private Hospital Subiaco
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Posted 8 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
These outcomes will be used 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).
Detailed description
This project is being conducted by Perth Hip and Knee Clinic. 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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functionally aligned Total Knee Arthroplasty | Active comparator | Procedure: Functionally Aligned Total Knee ArthroplastyKnee arthroplasty performed using a functional alignment theory |
| Mechanical axis aligned Total Knee Arthroplasty | Active comparator | Procedure: Mechanically Aligned Total Knee ArthroplastyKnee arthroplasty performed using a mechanical alignment theory |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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 principle.
- Patient has bone loss that requires augmentation
- Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA (e.g., post-high tibial or distal femoral osteotomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functionally Aligned Total Knee ArthroplastyFemoral + 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. | Procedure or surgery | Functionally aligned Total Knee Arthroplasty |
| Mechanically Aligned Total Knee ArthroplastyTibial 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. | Procedure or surgery | Mechanical axis aligned Total Knee Arthroplasty |
Primary outcome
Change in Forgotten Joint Score After 2 Years From Baseline
Time frame: Preoperatively and 2 years postoperatively
Difference in relative change in Forgotten Joint Score (2 years post-operatively compared to preoperatively) between FA and MA patients. Scale 0-100 with higher scores being a better outcome
Change in Oxford Knee Score After 2 Years From Baseline
Time frame: Preoperatively and 2 years postoperatively
Difference in relative change in Oxford Knee Score (2 years post-operatively compared to preoperatively) between FA and MA patients. Scale 0-48 with higher scores being a better outcome.
Change in Range of Motion After 2 Years From Baseline
Time frame: Preoperatively and 2 years postoperatively
Difference in relative change in range of motion via goniometry (2 years post-operatively compared to preoperatively) between FA and MA patients.
9 secondary outcomes
Determine Lower Limb Alignment Achieved With Both Alignment Techniques
Time frame: 3 Months post-operatively
Difference in Analgesia Requirements Between Patients in Alignment Groups
Time frame: 6 weeks, 3 months, 1 year, 2 years
Difference in Sagittal Stability of the Knee Post Replacement
Time frame: Preop, and post-operatively at 3 months, 1 year and 2 years
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
Intra-operative Balance Achieved With Different Alignment Techniques.
Time frame: Intraoperatively
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 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 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 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34372888Steer 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.
- Individual participant dataSharing planned: No. Not shared - for confidentiality of participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gavin Clark principal investigator
Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functionally Aligned Total Knee Arthroplasty and Mechanically Aligned Total Knee Arthroplasty in people with Osteoarthritis and Osteo Arthritis Knee, run by Perth Hip and Knee at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forgotten Joint Score After 2 Years From Baseline (time frame: Preoperatively and 2 years postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04748510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.