Clinical trial NCT06309433: Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periprosthetic Osteolysis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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. -

Primary outcomes:
measure: Periprosthetic bone mineral density measurement
timeFrame: at baseline (day 0)
measure: Periprosthetic bone mineral density measurement
timeFrame: 6 months
measure: Periprosthetic bone mineral density measurement
timeFrame: 12 months
measure: Periprosthetic bone mineral density measurement
timeFrame: 24 months
Secondary outcomes:
measure: Knee Society Score
timeFrame: at baseline (day 0)
measure: Knee Society Score
timeFrame: 6 months
measure: Knee Society Score
timeFrame: 12 months
measure: Knee Society Score
timeFrame: 24 months
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: at baseline (day 0)
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: 6 months
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: 12 months
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: 24 months
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: at baseline, (day 0)
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 6 months
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 12 months
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 24 months
measure: 36-Item Short Form Health Survey
timeFrame: at baseline (day 0)
measure: 36-Item Short Form Health Survey
timeFrame: 6 months
measure: 36-Item Short Form Health Survey
timeFrame: 12 months
measure: 36-Item Short Form Health Survey
timeFrame: 24 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Stefano Zaffagnini
state: Italia
city: Bologna
country: Italy
facility: Istituto ortoepdico rizzoli
Study officials:
References: