Clinical Utility and Gait Analysis of NextAR System AUS

NCT05863741 | Recruiting

• 1 other identifier: P02.022.01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  pre-op, 6 weeks, 6 months, 1 year, 2 years

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

  pre-op, 1 year

• To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score

  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

  pre-op, 6 weeks, 6 months, 1 year, 2 years

Study Arms (2)

control study

patients will be operated with conventional instrumentation

Device: Implantation of GMK Sphere with conventional instrumentation

NextAR study

patients will be operated using the NextAR guidance system

Device: Implantation of GMK Sphere using the NextAR guidance system

Interventions

Implantation of GMK Sphere with conventional instrumentation DEVICE

Implantation of GMK Sphere with conventional instrumentation (control group)

control study

Implantation of GMK Sphere using the NextAR guidance system DEVICE

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

NextAR study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

Fremantle Hospital

Fremantle, Australia

RECRUITING

Study Officials

• Ben Jeffcote

  Fremantle Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arianna Girardi

CONTACT

+41 91 696 60 60; girardi@medacta.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 18, 2023
• Study Start: May 15, 2022
• Primary Completion: May 12, 2025
• Study Completion: May 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)