Comparing NAVIO system to traditional methods for knee replacement
Official title: Comparison of Clinical Outcome and Alignment of NAVIO Total Knee Arthroplasty and Conventional Total Knee Arthroplasty A Prospective, Randomized, Controlled, Single Blind Study
Run by Sint-Trudo Hospital · NCT04230616 · Data updated 2026-11-12
This study is testing if a new robotic system for knee replacement can help people with knee arthritis feel better and recover faster compared to traditional methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Sint-Trudo Hospital Academic / other |
| Locations | 1 site (Sint-Truiden, Limburg) |
| Status | Recruiting |
| Started | February 1, 2021 |
| Main results expected | February 2022 |
| Study ends | February 2030 |
| Registry record updated | March 18, 2021 |
| Trial ID | NCT04230616 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with painful and disabled knee joints due to osteoarthritis who require pain relief and functional improvement.
✕Probably not a fit
Patients with active infections, previous joint replacement failures, or those unable to undergo a CT scan 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 study aims to evaluate the efficacy, safety, and cost-effectiveness of the NAVIO™ system in total knee arthroplasty compared to conventional intramedullary alignment guides. Participants with osteoarthritis affecting their knee will undergo total knee replacement using either method. The study will assess outcomes such as pain relief and functional improvement post-surgery. The hypothesis is that the NAVIO™ system will demonstrate at least equivalent safety and efficiency compared to traditional methods.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and patient satisfaction in knee replacement procedures.
How similar studies have gone: Other studies have shown promising results with innovative surgical techniques in knee replacement, suggesting potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved, as assessed by X-ray * High need to obtain pain relief and improve function * Above 18 years old * Able and willing to follow instructions * Informed consent Exclusion Criteria: * Active infection in knee * General infection * Failure of previous joint replacement * Post-operative or post traumatic malalignment of the knee/leg * Pregnancy * Not able or willing to undergo CT-scan
Where it's running
-
Orthopaedic Association Sint-Trudo Hospital
Sint-Truiden, Limburg, Belgium Recruiting
Study contacts
- Principal investigator: Peter Bollars, Dr. — Orthopedic Association Sint-Trudo Hospital
- Study coordinator: Peter Bollars, Dr.
- Email: peter.bollars@stzh.be
- Phone: +3211 33 42 86
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.