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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
View:

• 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.

Locations
Other Locations
Italy
Stefano Zaffagnini
RECRUITING
Bologna
Contact Information
Primary
Stefano Zaffagnini, Prof
stefano.zaffagnini@unibo.it
0516366075
Time Frame
Start Date: 2023-01-13
Estimated Completion Date: 2027-03
Participants
Target number of participants: 40
Treatments
Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov