NCT06321042 Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors
| NCT ID | NCT06321042 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Prosthesis Durability |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-01-13 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2023-01-13 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;
Eligibility Criteria
Inclusion Criteria: 1. Male and female subjects 50 years of age or older and less than 85 years of age (\>50 and \<85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes: * to. Primary or secondary osteoarthritis * b. Collagen disorders and/or avascular necrosis of femoral condyle * c. Moderate valgus, varus or flexion deformities (HKA between ± 10°, flexion contracture \<10°) - 2. Patients consent and able to complete scheduled study procedures and follow-up assessments. 3. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee. Exclusion Criteria: * Simultaneous participation in other studies * Patients not capable of understanding and wanting and therefore unable to sign the informed consent * Patients who have already undergone hip or ankle arthroplasty, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06321042 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Prosthesis Durability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06321042 currently recruiting?
Yes, NCT06321042 is actively recruiting participants. Contact the research team at stefano.zaffagnini@unibo.it for enrollment information.
Where is the NCT06321042 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06321042 clinical trial?
NCT06321042 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 40 participants.