Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating the NextAR System for Knee Surgery Outcomes

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).

Run by Medacta International SA · NCT05863741 · Data updated 2026-11-12

This study is testing if a new navigation system for knee surgery can help patients have better knee alignment and outcomes after their total knee replacement.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorMedacta International SA
Industry-sponsored
Locations1 site (Fremantle)
StatusRecruiting
StartedMay 15, 2022
Main results expectedMay 12, 2025
Study endsMay 2026
Registry record updatedSeptember 29, 2025
Trial IDNCT05863741 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years with end-stage osteoarthritis of the knee who are suitable for total knee arthroplasty.

Probably not a fit

Patients with chronic infections, significant psychiatric issues, or those who are morbidly obese may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the clinical utility of the NextAR navigation system in total knee arthroplasty (TKA) by analyzing soft tissue balance patterns to achieve more natural knee alignment. It aims to determine if the use of NextAR data can enhance patient outcomes and knee kinematics post-surgery, with assessments conducted preoperatively and at multiple postoperative intervals. The study will utilize standardized clinical evaluations, including various knee scores and 3D gait analysis, to measure the effectiveness of the intervention.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and enhanced quality of life for patients undergoing total knee arthroplasty.

How similar studies have gone: Other studies have shown promising results with similar navigation systems in improving surgical outcomes, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Fremantle Hospital
    Fremantle, Australia
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.