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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Periprosthetic Osteolysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PS TKA

Patients with Posterior stabilized Total knee replacement

Group Type ACTIVE_COMPARATOR

dual energy x-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

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

CR TKA

Patients with cruciate retaining Total knee replacement

Group Type ACTIVE_COMPARATOR

dual energy x-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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dual energy x-ray absorptiometry

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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. -

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No