Clinical trial NCT05863741: Clinical Utility and Gait Analysis of NextAR System AUS
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).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Total Knee Arthroplasty
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score
timeFrame: pre-op, 6 weeks, 6 months, 1 year, 2 years
Secondary outcomes:
measure: To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L
timeFrame: pre-op, 6 weeks, 6 months, 1 year, 2 years
measure: Determining the kinematics of the replaced knee as measured by 3D gait analysis.
timeFrame: pre-op, 1 year
measure: To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score
timeFrame: pre-op, 6 weeks, 6 months, 1 year, 2 years
measure: To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee
timeFrame: pre-op, 6 weeks, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Fremantle
country: Australia
facility: Fremantle Hospital
Study officials:
affiliation: Fremantle Hospital
name: Ben Jeffcote
role: PRINCIPAL_INVESTIGATOR
References: