Clinical Utility and Gait Analysis of NextAR System AUS

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.

Study Overview

• Status: Recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: Implantation of GMK Sphere with conventional instrumentation; Device: Implantation of GMK Sphere using the NextAR guidance system

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Arianna Girardi; Phone Number: +41 91 696 60 60; Email: girardi@medacta.ch

Study Locations

• Australia
  • Fremantle, Australia
    • Recruiting
    • Fremantle Hospital
    • Contact: Ben Jeffcote

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control study; patients will be operated with conventional instrumentation	Device: Implantation of GMK Sphere with conventional instrumentation; Implantation of GMK Sphere with conventional instrumentation (control group)
NextAR study; patients will be operated using the NextAR guidance system	Device: Implantation of GMK Sphere using the NextAR guidance system; Implantation of GMK Sphere using the NextAR guidance system (NextAR group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	pre-op, 6 weeks, 6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Ben Jeffcote, Fremantle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: P02.022.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No