Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors (SYMPHO-EM)

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Prosthesis Durability

Treatments: Device: Knee arthroplasty

Study type: Observational

Funder types: Other

Identifiers

NCT06321042

SYMPHO-EM

Details and patient eligibility

About

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;

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device

Treatment:

Device: Knee arthroplasty