Comparing computer-assisted and standard techniques in knee replacement surgery
CAS vs Tecnica Chirurgica Standard Nella Protesi Totale di Ginocchio: Confronto Dei Risultati Clinico-funzionali
NA · Istituto Ortopedico Rizzoli · NCT06608745
This study is testing whether using computer-assisted techniques during knee replacement surgery leads to better results and lower costs compared to standard surgery methods for patients needing this procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06608745 on ClinicalTrials.gov |
What this trial studies
This study enrolls patients who require total knee replacement surgery to compare the outcomes of conventional surgical techniques with those that utilize computer-assisted navigation. It aims to evaluate clinical and functional results, perioperative bleeding, and healthcare costs associated with each technique. A total of 160 patients will be divided into two groups of 80, each receiving one of the surgical approaches. The study will assess various metrics to determine the effectiveness and efficiency of the two methods.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 45 and older with primary or secondary gonarthrosis indicated for knee arthroplasty.
Not a fit: Patients who are unable to provide informed consent, have a nickel allergy, or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced healthcare costs for patients undergoing knee replacement surgery.
How similar studies have performed: Other studies have shown promising results with computer-assisted techniques in orthopedic surgeries, suggesting potential benefits in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with primary or secondary gonarthrosis with indication for knee arthroplasty with primary implant * Males and females aged ≥ 45 * Willingness to participate in the study * Acquisition of informed consent to participate Exclusion Criteria: * Patients who are not capable of understanding and willing, and therefore unable to express consent to participation in the study * Patient refusal to participate in the study and to sign the informed consent * Nickel allergy (suspected or diagnosed) * Pregnant women or women of childbearing age who cannot exclude pregnancy
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Dallari (M.D.)
- Email: dante.dallari@ior.it
- Phone: 39+0516366252
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: Knee Arthroplasty, Total