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

Istituto Ortopedico Rizzoli50 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Periprosthetic Osteolysis

Interventions

dual energy x-ray absorptiometryDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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. -

Locations (2)

Stefano Zaffagnini

Bologna, Italia, Italy

RECRUITING

Istituto ortoepdico rizzoli

Bologna, Italy

RECRUITING

Outcomes

Primary Outcomes

Periprosthetic bone mineral density measurement

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

Time frame: at baseline (day 0)

Periprosthetic bone mineral density measurement

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

Time frame: 6 months

Periprosthetic bone mineral density measurement

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

Time frame: 12 months

Periprosthetic bone mineral density measurement

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

Time frame: 24 months

Secondary Outcomes

Knee Society Score

Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

Time frame: at baseline (day 0)

Knee Society Score

Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

Time frame: 6 months

Knee Society Score

Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

Time frame: 12 months

Knee Society Score

Data from ClinicalTrials.gov

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Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

Time frame: 24 months

Western Ontario and McMaster Universities Arthritis Index

The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96

Time frame: at baseline (day 0)

Western Ontario and McMaster Universities Arthritis Index

The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96

Time frame: 6 months

Western Ontario and McMaster Universities Arthritis Index

The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96

Time frame: 12 months

Western Ontario and McMaster Universities Arthritis Index

The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96

Time frame: 24 months

Knee injury and Osteoarthritis Outcome Score

The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living, Function in Sport and Recreation, and knee-related Quality of Life . the score goes from 0 to 100

Time frame: at baseline, (day 0)

Knee injury and Osteoarthritis Outcome Score

The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living , Function in Sport and Recreation , and knee-related Quality of Life . the score goes from 0 to 100

Time frame: 6 months

Knee injury and Osteoarthritis Outcome Score

The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living , Function in Sport and Recreation , and knee-related Quality of Life . the score goes from 0 to 100

Time frame: 12 months

Knee injury and Osteoarthritis Outcome Score

The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living , Function in Sport and Recreation , and knee-related Quality of Life . the score goes from 0 to 100

Time frame: 24 months

36-Item Short Form Health Survey

is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.

Time frame: at baseline (day 0)

36-Item Short Form Health Survey

Time frame: 6 months

36-Item Short Form Health Survey

Time frame: 12 months

36-Item Short Form Health Survey

Time frame: 24 months