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

Recruiting now

Conditions studied: Prosthesis Durability

In brief

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;

Key facts

Study ID

NCT06321042

Run by

Istituto Ortopedico Rizzoli

People needed

40

Starts

2023-01-13

Expected to finish

2027-03-01

Last updated by the study team

2026-04-23

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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°) -
• Patients consent and able to complete scheduled study procedures and follow-up assessments.
• Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.

You may not qualify if…

• 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.

Where it is running

• Stefano Zaffagnini — Bologna, Italia, Italy (enrolling)

Full record on ClinicalTrials.gov

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