Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05863741




Registration number
NCT05863741
Ethics application status
Date submitted
26/04/2023
Date registered
18/05/2023
Date last updated
2/06/2023

Titles & IDs
Public title
Clinical Utility and Gait Analysis of NextAR System AUS
Scientific 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).
Secondary ID [1] 0 0
P02.022.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Implantation of GMK Sphere with conventional instrumentation
Treatment: Devices - Implantation of GMK Sphere using the NextAR guidance system

control study - patients will be operated with conventional instrumentation

NextAR study - patients will be operated using the NextAR guidance system


Treatment: Devices: Implantation of GMK Sphere with conventional instrumentation
Implantation of GMK Sphere with conventional instrumentation (control group)

Treatment: Devices: Implantation of GMK Sphere using the NextAR guidance system
Implantation of GMK Sphere using the NextAR guidance system (NextAR group)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score
Timepoint [1] 0 0
pre-op, 6 weeks, 6 months, 1 year, 2 years
Secondary outcome [1] 0 0
To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L
Timepoint [1] 0 0
pre-op, 6 weeks, 6 months, 1 year, 2 years
Secondary outcome [2] 0 0
Determining the kinematics of the replaced knee as measured by 3D gait analysis.
Timepoint [2] 0 0
pre-op, 1 year
Secondary outcome [3] 0 0
To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score
Timepoint [3] 0 0
pre-op, 6 weeks, 6 months, 1 year, 2 years
Secondary outcome [4] 0 0
To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee
Timepoint [4] 0 0
pre-op, 6 weeks, 6 months, 1 year, 2 years

Eligibility
Key inclusion criteria
- End-stage osteoarthritis of the knee suitable for total knee arthroplasty.

- Aged over 18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
- Fremantle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medacta International SA
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05863741
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Jeffcote
Address 0 0
Fremantle Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Arianna Girardi
Address 0 0
Country 0 0
Phone 0 0
+41 91 696 60 60
Fax 0 0
Email 0 0
girardi@medacta.ch
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05863741