Comparing bone density changes in knee replacement patients with different implant designs
Official title: 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
Run by Istituto Ortopedico Rizzoli · NCT06309433 · Data updated 2026-11-12
This study is testing how different knee implant designs affect bone density changes in patients aged 45 and older who are getting knee replacements.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 2 sites (Bologna, Italia and 1 other locations) |
| Status | Recruiting |
| Started | August 30, 2023 |
| Main results expected | December 2027 |
| Study ends | April 2028 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT06309433 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients aged 45 and older who require primary cemented total knee replacement due to severe knee pain and disability.
✕Probably not a fit
Patients under 45 years old or those with previous knee surgeries or specific medical conditions like rheumatoid arthritis or diabetes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the changes in bone mineral density (BMD) around the femoral and tibial areas in patients undergoing total knee arthroplasty (TKA) with two different implant designs: posterior stabilization and posterior cruciate preservation. Using dual energy x-ray absorptiometry (DXA), the study aims to assess the impact of these designs on periprosthetic osteolysis over a two-year follow-up period. Patients aged 45 and older who are candidates for primary cemented TKA will be included, ensuring a homogenous cohort by excluding those with prior knee surgeries or certain medical conditions.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes in knee replacement surgeries by identifying which implant design better preserves bone density.
How similar studies have gone: While this study explores a specific comparison of implant designs, similar studies have shown varying success in understanding the impact of different knee prosthesis designs on bone health.
Who can join: the full rules
Show full inclusion / exclusion 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. -
Where it's running
-
Stefano Zaffagnini
Bologna, Italia, Italy Recruiting -
Istituto ortoepdico rizzoli
Bologna, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.