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Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design (DXA-TKA)

I

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Periprosthetic Osteolysis

Treatments

Diagnostic Test: dual energy x-ray absorptiometry

Study type

Interventional

Funder types

Other

Identifiers

NCT06309433
DXA-TKA

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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. -

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

PS TKA
Active Comparator group
Description:
Patients with Posterior stabilized Total knee replacement
Treatment:
Diagnostic Test: dual energy x-ray absorptiometry
CR TKA
Active Comparator group
Description:
Patients with cruciate retaining Total knee replacement
Treatment:
Diagnostic Test: dual energy x-ray absorptiometry

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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