Clinical Utility and Gait Analysis of NextAR System AUS

Medacta

Status: Enrolling

Conditions: Total Knee Arthroplasty

Treatments: Device: Implantation of GMK Sphere with conventional instrumentation; Device: Implantation of GMK Sphere using the NextAR guidance system

Study type: Observational

Funder types: Industry

Identifiers

NCT05863741

P02.022.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

control study

Description:

patients will be operated with conventional instrumentation

Treatment:

Device: Implantation of GMK Sphere with conventional instrumentation

NextAR study

Description:

patients will be operated using the NextAR guidance system

Treatment:

Device: Implantation of GMK Sphere using the NextAR guidance system