CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results
The study involves the enrollment of a sample of patients with indication for total knee replacement surgery in order to compare the conventional surgical technique currently used in the reference departments with the surgical technique with the aid of computer-assisted navigation. The comparison between the two techni
| Condition(s) | Knee Arthroplasty, Total |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The study involves the enrollment of a sample of patients with indication for total knee replacement surgery in order to compare the conventional surgical technique currently used in the reference departments with the surgical technique with the aid of computer-assisted navigation. The comparison between the two techniques will be performed in terms of clinical-functional results, perioperative bleeding and healthcare costs (surgical time, hospital stay). The research protocol involves the participation of 160 total patients divided into two groups, of 80 patients each, by type of surgical technique. |
| Who can participate | 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 |
| Ages | 45 Years |
| Sex | All |
| Lead sponsor | Istituto Ortopedico Rizzoli |
| Locations | Bologna, Italy |
| Start date | 2024-02-12 |
| NCT ID | NCT06608745 |
| Official listing | https://clinicaltrials.gov/study/NCT06608745 |