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Recruiting NCT06309433

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

No phase Interventional Periprosthetic Osteolysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dual energy x-ray absorptiometry.
Who it may be relevant to
Registry conditions: Periprosthetic Osteolysis. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Diagnostic test dual energy x-ray absorptiometry
    Patient will undergo periodic (6-12-24m) dexa scans on the periprosthetic bone

Primary outcome measures

  • Periprosthetic bone mineral density measurement [Time frame: at baseline (day 0)]
  • Periprosthetic bone mineral density measurement [Time frame: 6 months]
  • Periprosthetic bone mineral density measurement [Time frame: 12 months]
  • Periprosthetic bone mineral density measurement [Time frame: 24 months]
Secondary outcome measures (12)
  • Knee Society Score [Time frame: at baseline (day 0)]
  • Knee Society Score [Time frame: 6 months]
  • Knee Society Score [Time frame: 12 months]
  • Knee Society Score [Time frame: 24 months]
  • Western Ontario and McMaster Universities Arthritis Index [Time frame: at baseline (day 0)]
  • Western Ontario and McMaster Universities Arthritis Index [Time frame: 6 months]
  • Western Ontario and McMaster Universities Arthritis Index [Time frame: 12 months]
  • Western Ontario and McMaster Universities Arthritis Index [Time frame: 24 months]
  • Knee injury and Osteoarthritis Outcome Score [Time frame: at baseline, (day 0)]
  • Knee injury and Osteoarthritis Outcome Score [Time frame: 6 months]
  • Knee injury and Osteoarthritis Outcome Score [Time frame: 12 months]
  • Knee injury and Osteoarthritis Outcome Score [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Italy · 2 centers
  • Stefano Zaffagnini — Bologna
  • Istituto ortoepdico rizzoli — Bologna

Identifiers

NCT: NCT06309433 · DXA-TKA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗