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

NCT06309433 | Recruiting

• 1 other identifier: DXA-TKA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Periprosthetic Osteolysis

Outcome Measures

Primary Outcomes (4)

• Periprosthetic bone mineral density measurement

  measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry

  at baseline (day 0)

• Periprosthetic bone mineral density measurement

  measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry

  6 months

• Periprosthetic bone mineral density measurement

  measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry

  12 months

• Periprosthetic bone mineral density measurement

  measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry

  24 months

Secondary Outcomes (16)

• Knee Society Score

  at baseline (day 0)

• Knee Society Score

  6 months

• Knee Society Score

  12 months

• Knee Society Score

  24 months

• Western Ontario and McMaster Universities Arthritis Index

  at baseline (day 0)

Study Arms (2)

PS TKA

ACTIVE COMPARATOR

Patients with Posterior stabilized Total knee replacement

Diagnostic Test: dual energy x-ray absorptiometry

CR TKA

ACTIVE COMPARATOR

Patients with cruciate retaining Total knee replacement

Diagnostic Test: dual energy x-ray absorptiometry

Interventions

dual energy x-ray absorptiometry DIAGNOSTIC_TEST

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

CR TKA; PS TKA

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (2)

Stefano Zaffagnini

Bologna, Italia, Italy

RECRUITING

Istituto ortoepdico rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: March 13, 2024
• Study Start: August 30, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)