Using a navigation system to improve knee replacement surgery outcomes
Surgical Outcomes of the Accelerometer-based Navigation System for Total Knee Arthroplasty
Chinese University of Hong Kong · NCT04037228
This study tests if using a special navigation system during knee replacement surgery can help people with osteoarthritis have better results and feel more satisfied with their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04037228 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of the KneeAlign 2 system in achieving accurate alignment during total knee arthroplasty (TKA) for patients with osteoarthritis. The study focuses on the relationship between component alignment and surgical success, as misalignment can lead to early implant failure. Participants will include adults over 18 years old who are undergoing primary TKA due to osteoarthritis, with careful selection criteria to ensure appropriate candidates. The study aims to gather data on surgical outcomes and patient satisfaction following the use of this advanced navigation technology.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with osteoarthritis who are scheduled for primary total knee arthroplasty.
Not a fit: Patients with unicondylar or patellofemoral arthroplasty needs, serious pathologies, or those undergoing revision surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced failure rates in knee replacement surgeries.
How similar studies have performed: Previous studies have shown promising results with computer-assisted navigation techniques in improving surgical accuracy, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female subjects aged over 18 years old * All patients must provide their written consent * patients with a history of osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis who will receive a primary, posterior-stabilized TKA. * All patients should have at least 8 years of school education; * Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 or above Exclusion Criteria: * Patients are planned to receive a unicondylar or patellofemoral arthroplasty. * Patients with previous cases of alcoholism or drug abuse; * Pregnancy and breast-feeding; * Presence of serious pathologies; * revision surgery * Knee infection * Non-consenting patients who have not provided the written Informed Consent; * Mechanical instability, ligamentous laxity/deficiency and gross deformity
Where this trial is running
Hong Kong
- Department of Orthopaedics & Traumatology — Hong Kong, Hong Kong (RECRUITING)
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.
Conditions: Arthroplasty, Replacement, Knee, Radiotherapy, Image-Guided