RecruitingNot ApplicableNCT06309433

Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design

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


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

50 participants

Start Date

Aug 30, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria3

  • 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. -

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Interventions

DIAGNOSTIC_TESTdual energy x-ray absorptiometry

Patient will undergo periodic (6-12-24m) dexa scans on the periprosthetic bone


Locations(2)

Stefano Zaffagnini

Bologna, Italia, Italy

Istituto ortoepdico rizzoli

Bologna, Italy

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NCT06309433


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