NCT06309433 Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design
| NCT ID | NCT06309433 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Periprosthetic Osteolysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-08-30 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-08-30 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Patients aged ≥ 45 years 2. 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. Exclusion Criteria: 1. Patients aged \< 45 years; 2. 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; 3. Pregnant women. -
Frequently Asked Questions
Who can join the NCT06309433 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Periprosthetic Osteolysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06309433 currently recruiting?
Yes, NCT06309433 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituto Ortopedico Rizzoli to inquire about joining.
Where is the NCT06309433 trial being conducted?
This trial is being conducted at Bologna, Italy, Bologna, Italy.
Who is sponsoring the NCT06309433 clinical trial?
NCT06309433 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 50 participants.