Total Knee ArthroplastyNCT05863741
Clinical Utility and Gait Analysis of NextAR System AUS
An observational study of Total Knee Arthroplasty, run by Medacta International SA at 1 site in Australia.
Trial summary
This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Implantation of GMK Sphere with conventional instrumentation and Implantation of GMK Sphere using the NextAR guidance system
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 15 May 2022to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The trial will include two groups of 50 patients in each group. This is based on a power calculation assuming a difference in Forgotten Join Score of greater than 5 points. This calculation allows for a loss to follow-up of 10%. The study will conclude once the patients involved have completed 2 years of follow-up.
Who may be able to join
- End-stage osteoarthritis of the knee suitable for total knee arthroplasty.
- Aged over 18 years.
Who cannot join
- Unsuitable for TKR due to chronic infection, medical disease, inability to consent, inability to attend for post-operative follow-up, significant psychiatric issues, substance abuse issues
- Previous reconstructive/fracture/arthroplasty surgery on affected knee
- Active inflammation arthropathy
- Significant extra articular deformity
- Morbidly Obese (BMI >40)
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Fremantle Hospital
Fremantle
Ben Jeffcote
About this study
Official title: Does Personalized Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilized Knee Arthroplasty? A Prospective, Randomized Study Investigating the Clinical Utility of the NextAR Navigation System (NextAR).
This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.
Read the detailed description
This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.
The aims of this study are:
- To determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment
- To determine whether NextAR system data contributes to improving patient outcomes and knee kinematics following TKR surgery, by providing greater flexion range that is equivalent to native knee motion.
- To assess clinical outcomes measured by standardised assessments, including radiographic evidence, the Forgotten Joint Score (FJS), the Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L) questionnaires.
- Determining the kinematics of the replaced knee as measured by 3D gait analysis.
According to study protocol, clinical evaluation is performed preoperatively and postoperatively at 6 weeks, 6 months, 1, and 2 years with the use of the Forgotten Joint Score (FJS), Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L).
CT scan is performed preoperatively and at 6-weeks after surgery, while X-ray assessment is performed at baseline and at the 1-year follow up.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Implantation of GMK Sphere with conventional instrumentation, Implantation of GMK Sphere using the NextAR guidance system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of GMK Sphere with conventional instrumentationDevice
Implantation of GMK Sphere with conventional instrumentation (control group)
Implantation of GMK Sphere using the NextAR guidance systemDevice
Implantation of GMK Sphere using the NextAR guidance system (NextAR group)
| Study group | Role | What they receive |
|---|---|---|
| control study | patients will be operated with conventional instrumentation Receives: Device: Implantation of GMK Sphere with conventional instrumentation | |
| NextAR study | patients will be operated using the NextAR guidance system Receives: Device: Implantation of GMK Sphere using the NextAR guidance system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score
To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score
- Forgotten Joint Score measures the patient's ability to forget about the joint as a result of successful treatment and is based on the premise that the best arthroplasty is one the patient forgets. This score goes from a minimum of 0 to a maximum of 100 points.
Measured: pre-op, 6 weeks, 6 months, 1 year, 2 years
Secondary outcomes (4)
To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L
To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L
The EQ5D-5L comprises of 6 questions survey that measures generic health-related quality of life. This score goes from a minimum of 0 to a maximum of 1 points.
Measured: pre-op, 6 weeks, 6 months, 1 year, 2 years
Determining the kinematics of the replaced knee as measured by 3D gait analysis.
The purpose of the gait analysis will be to assess the variation in kinematics between the patients replaced knee (in both study groups) compared to normal knee kinematic data reported in the literature. The hypothesis being tested is that alteration of component position to give more normal ligament tension, will more resemble normal knee kinematics. (n=20) will be sufficient to conduct the gait analysis. These patients will be selected from the overall cohort for enrolment at 12 months post-surgery and matched for age, gender, BMI and osteoarthritis pattern. The comparison will involve comparing the average kinematic data values obtained in group 1 (NextAR data provided at surgery) vs the reported values in the literature and the same analysis will be repeated for patients in group 2 (NextAR data not provided at surgery).comparison will be made between the two groups in terms of which more closely replicates the kinematics of the non-arthritic knee
Measured: pre-op, 1 year
To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score
To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score
the Oxford Knee Score is a questionnaire that has been specifically developed to assess knee function and pain. It is short, reproducible and extensively referenced in orthopaedic literature, making it a preferred tool for studies. This score goes from a minimum of 0 to a maximum of 48 points.
Measured: pre-op, 6 weeks, 6 months, 1 year, 2 years
To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee
To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee
International Knee Documentation Committee is questionnaire that evaluates physical activity, level of pain and knee functionality in sporting activities. This score goes from a minimum of 0 to a maximum of 100 points.
Measured: pre-op, 6 weeks, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start15 May 2022
- Primary completion12 May 2025
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Medacta International SAThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Jeffcote, Principal investigator, Fremantle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863741
- Sponsor's protocol ID
- P02.022.01
- Status last verified
- Sep 2025
- First submitted
- 26 Apr 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Personalized Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilized Knee Arthroplasty? A Prospective, Randomized Study Investigating the Clinical Utility of the NextAR Navigation System (NextAR).
- ClinicalTrials.gov ID
- NCT05863741
- Acronym / sponsor ID
- P02.022.01
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 15 May 2022 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.
Detailed description
This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.
The aims of this study are:
- To determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment
- To determine whether NextAR system data contributes to improving patient outcomes and knee kinematics following TKR surgery, by providing greater flexion range that is equivalent to native knee motion.
- To assess clinical outcomes measured by standardised assessments, including radiographic evidence, the Forgotten Joint Score (FJS), the Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L) questionnaires.
- Determining the kinematics of the replaced knee as measured by 3D gait analysis.
According to study protocol, clinical evaluation is performed preoperatively and postoperatively at 6 weeks, 6 months, 1, and 2 years with the use of the Forgotten Joint Score (FJS), Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L).
CT scan is performed preoperatively and at 6-weeks after surgery, while X-ray assessment is performed at baseline and at the 1-year follow up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control study | – | Device: Implantation of GMK Sphere with conventional instrumentationpatients will be operated with conventional instrumentation |
| NextAR study | – | Device: Implantation of GMK Sphere using the NextAR guidance systempatients will be operated using the NextAR guidance system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The trial will include two groups of 50 patients in each group. This is based on a power calculation assuming a difference in Forgotten Join Score of greater than 5 points. This calculation allows for a loss to follow-up of 10%. The study will conclude once the patients involved have completed 2 years of follow-up.
Key inclusion criteria (2 listed)
- End-stage osteoarthritis of the knee suitable for total knee arthroplasty.
- Aged over 18 years.
Key exclusion criteria (6 listed)
- Unsuitable for TKR due to chronic infection, medical disease, inability to consent, inability to attend for post-operative follow-up, significant psychiatric issues, substance abuse issues
- Previous reconstructive/fracture/arthroplasty surgery on affected knee
- Active inflammation arthropathy
- Significant extra articular deformity
- Morbidly Obese (BMI >40)
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 |
|---|---|---|
| Implantation of GMK Sphere with conventional instrumentationImplantation of GMK Sphere with conventional instrumentation (control group) | Device | control study |
| Implantation of GMK Sphere using the NextAR guidance systemImplantation of GMK Sphere using the NextAR guidance system (NextAR group) | Device | NextAR study |
Primary outcome
Determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score
Time frame: pre-op, 6 weeks, 6 months, 1 year, 2 years
To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score - Forgotten Joint Score measures the patient's ability to forget about the joint as a result of successful treatment and is based on the premise that the best arthroplasty is one the patient forgets. This score goes from a minimum of 0 to a maximum of 100 points.
4 secondary outcomes
To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L
Time frame: pre-op, 6 weeks, 6 months, 1 year, 2 years
Determining the kinematics of the replaced knee as measured by 3D gait analysis.
Time frame: pre-op, 1 year
To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score
Time frame: pre-op, 6 weeks, 6 months, 1 year, 2 years
To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee
Time frame: pre-op, 6 weeks, 6 months, 1 year, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Ben Jeffcote principal investigator
Fremantle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by Medacta International SA at 1 site 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arianna Girardi (+41 91 696 60 60, girardi@medacta.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score (time frame: pre-op, 6 weeks, 6 months, 1 year, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.