RecruitingNCT05863741

Clinical Utility and Gait Analysis of NextAR System AUS

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).


Sponsor

Medacta International SA

Enrollment

100 participants

Start Date

May 15, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether using augmented reality (AR) navigation technology — specifically the NextAR system — during total knee replacement surgery leads to better outcomes for patients. The NextAR system overlays digital information onto the surgeon's view during the operation, helping them position the new knee joint with greater precision. Researchers are also studying how patients walk (gait analysis) before and after surgery to see whether the technology improves movement. Adults aged 18 and older who have severe knee osteoarthritis bad enough to require a total knee replacement are eligible to join. People who have had previous surgery on the affected knee, have active inflammatory arthritis, significant bone deformity, a BMI over 40, or are pregnant cannot participate. Participants will have their knee replaced using the AR-guided system and will attend follow-up visits to assess their recovery, pain levels, and walking ability. This research matters because knee replacement is one of the most common major surgeries worldwide, and even small improvements in implant positioning can lead to less pain, better movement, and longer-lasting results for millions of patients.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImplantation of GMK Sphere with conventional instrumentation

Implantation of GMK Sphere with conventional instrumentation (control group)

DEVICEImplantation of GMK Sphere using the NextAR guidance system

Implantation of GMK Sphere using the NextAR guidance system (NextAR group)


Locations(1)

Fremantle Hospital

Fremantle, Australia

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NCT05863741


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