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Recruiting NCT06321042

Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors

Conditions: Prosthesis Durability

Sponsor: Istituto Ortopedico Rizzoli

trial.available_in: БГ
Overview
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;
Who can participate
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.
Interventions
Knee arthroplasty
DEVICE
Locations 1
Italy (1)
Stefano Zaffagnini
Bologna , Italia
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
50 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
13.01.2023
Completion date
01.03.2027
Registry ID
NCT06321042
Source
clinicaltrials.gov
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