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NCT Number: NCT05863741

Clinical Utility and Gait Analysis of NextAR System AUS

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fremantle Hospital

Fremantle, Australia

Location status: Recruiting

Location contact

Ben Jeffcote

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • End-stage osteoarthritis of the knee suitable for total knee arthroplasty.
  • Aged over 18 years.

Exclusion criteria

  • 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

Treatment and study plan

Implantation of GMK Sphere with conventional instrumentation

Device

Implantation of GMK Sphere with conventional instrumentation (control group)

Implantation of GMK Sphere using the NextAR guidance system

Device

Implantation of GMK Sphere using the NextAR guidance system (NextAR group)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Determining the kinematics of the replaced knee as measured by 3D gait analysis.

    Time frame: pre-op, 1 year

    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

  3. 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 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.

  4. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arianna Girardi

CONTACT

[email protected]

+41 91 696 60 60

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study 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).

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 18, 2023
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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