Assessment of Bone Mineral Density at the Interface With the Femoral and Tibial Components in Patients Undergoing Total Knee Prosthesis of Different Design and Material

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

compare changes in BMD via DXA at the level of the femoral and tibial periprosthetic bone between two groups of patients undergoing cemented TKA of different design (posterior stabilization vs posterior cruciate preservation) with proms at a 2-year follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• Patients aged ≥ 45 years

• Patients 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:

⁃ to. Primary or secondary osteoarthritis b. Collagen disorders and/or avascular necrosis of the femoral condyle c. Moderate valgus, varus or flexion deformities (HKA within ±10°, flexion contracture \<10°) 3. Patients consenting and able to complete planned study procedures and follow-up assessments 4. Patients informed about the nature of the study who signed the informed consent approved by the ethics committee.

Locations
Other Locations
Italy
Istituto ortoepdico rizzoli
RECRUITING
Bologna
Stefano Zaffagnini
RECRUITING
Bologna
Time Frame
Start Date: 2023-08-30
Estimated Completion Date: 2028-04
Participants
Target number of participants: 50
Treatments
Active_comparator: PS TKA
Patients with Posterior stabilized Total knee replacement
Active_comparator: CR TKA
Patients with cruciate retaining Total knee replacement
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov