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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05863741