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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Periprosthetic Osteolysis
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Periprosthetic bone mineral density measurement
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Stefano Zaffagnini
professor
Istituto Ortopedico Rizzoli
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°)
- •Patients consenting and able to complete planned study procedures and follow-up assessments
- •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. -
Outcomes
Primary Outcomes
Periprosthetic bone mineral density measurement
Time Frame: 24 months
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Periprosthetic bone mineral density measurement
Time Frame: at baseline (day 0)
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Periprosthetic bone mineral density measurement
Time Frame: 6 months
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Periprosthetic bone mineral density measurement
Time Frame: 12 months
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Secondary Outcomes
- Western Ontario and McMaster Universities Arthritis Index(24 months)
- Knee Society Score(24 months)
- Knee injury and Osteoarthritis Outcome Score(24 months)
- 36-Item Short Form Health Survey(24 months)
- Knee Society Score(at baseline (day 0))
- Knee Society Score(6 months)
- Knee Society Score(12 months)
- Western Ontario and McMaster Universities Arthritis Index(at baseline (day 0))
- Western Ontario and McMaster Universities Arthritis Index(6 months)
- Western Ontario and McMaster Universities Arthritis Index(12 months)
- Knee injury and Osteoarthritis Outcome Score(at baseline, (day 0))
- Knee injury and Osteoarthritis Outcome Score(6 months)
- Knee injury and Osteoarthritis Outcome Score(12 months)
- 36-Item Short Form Health Survey(at baseline (day 0))
- 36-Item Short Form Health Survey(6 months)
- 36-Item Short Form Health Survey(12 months)