Evaluating the NextAR System for Knee Surgery Outcomes
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).
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 type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 1 site (Fremantle) |
| Trial ID | NCT05863741 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with end-stage osteoarthritis of the knee who are suitable for total knee arthroplasty.
Not a fit: Patients with chronic infections, significant psychiatric issues, or those who are morbidly obese may not benefit from this study.
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 performed: Other studies have shown promising results with similar navigation systems in improving surgical outcomes, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Fremantle
- Fremantle Hospital — Fremantle, Australia (Recruiting)
Study contacts
- Principal investigator: Ben Jeffcote — Fremantle Hospital
- Study coordinator: Arianna Girardi
- Email: girardi@medacta.ch
- Phone: +41 91 696 60 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.