Clinical Utility and Gait Analysis of NextAR System AUS
ConditionTotal Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedacta International SA
About this trial
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.
Eligibility criteria
Qualifiers
End-stage osteoarthritis of the knee suitable for total knee arthroplasty.
Aged over 18 years.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Implantation of GMK Sphere with conventional instrumentation
- Implantation of GMK Sphere using the NextAR guidance system
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov