Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design
Recruiting now · Not applicable
Conditions studied: Periprosthetic Osteolysis
In brief
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.
Key facts
- Study ID
- NCT06309433
- Run by
- Istituto Ortopedico Rizzoli
- People needed
- 50
- Starts
- 2023-08-30
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients aged < 45 years;
- Patients who have already undergone hip or knee arthroplasty ankle, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases. In this way, homogeneity of the investigated cohort will be guaranteed;
- Pregnant women. -
Where it is running
- Stefano Zaffagnini — Bologna, Italia, Italy (enrolling)
- Istituto ortoepdico rizzoli — Bologna, Italy (enrolling)
Full record on ClinicalTrials.gov
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