Analysis of Defined Elements on DXA in Patients Undergoing Hip Arthroplasty

NCT06324708 | Unknown

• 1 other identifier: THA_DXA
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the role of two-dimensional FEM models obtained from DXA images in the longitudinal assessment of periprosthetic bone, in subjects undergoing hip arthroplasty. Specifically, the study will focus on the joint analysis of changes in the parameters of bone mineral density (BMD) and Bone Strain Index (BSI) at the level of periprosthetic bone of the proximal femur in patients undergoing hip replacement surgery using DXA, evaluating the densitometric variation of these two parameters over time, starting from an immediately postoperative data and checking the change at 6 months to follow the patient through the postoperative course

Conditions

Bone Resorption; Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

• Role of two-dimensional FEM models obtained from DXA images in longitudinal evaluation of periprosthetic bone

  The purpose of this study is to investigate the role of two-dimensional FEM models obtained from DXA images in longitudinal evaluation of periprosthetic bone, in subjects undergoing hip arthroplasty. Specifically, the study will focus on the joint analysis of changes in the parameters of bone mineral density (BMD) \[g/cm2\] and Bone Strain Index (BSI) at the periprosthetic bone level of the proximal femur in patients undergoing hip implant surgery using DXA, evaluating the densitometric change of these two parameters over time, starting from an immediately postoperative data and verifying the change at 6 months, to follow the patient through the postoperative course. Since there are no longitudinal evaluation studies of periprosthetic stress, measured by finite element analysis with BSI software, it was decided to focus on the variations in BMD as the main result, limiting the observation on the behavior of the BSI parameter with respect to the variations in BMD.

  12 months

Secondary Outcomes (6)

• Role of two-dimensional FEM models of bone resistance to loading

  12 months

• Identification of mechanical stress

  12 months

• Assesment with PROMs: VAS

  12 months

• Assesment with PROMs; HHS

  12 months

• Assesment with PROMs: SF12

  12 months

Study Arms (1)

Hip arthroplasty group

EXPERIMENTAL

This single group is composed by patients undergoing hip arthroplasty

Diagnostic Test: DXA

Interventions

DXA DIAGNOSTIC_TEST

Patients will undergo a femoral and lumbar DXA

Hip arthroplasty group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are candidates for elective hip arthroplasty surgery (indication determined only by the Orthopedic Surgeon)
• Patients with noninflammatory degenerative hip joint disease, including osteoarthritis and the outcomes of congenital hip dysplasia.
• Hip joint deformity correction surgery
• Patients aged 50 to 90 years (completed)
• ≤ Body Mass Index (BMI) ≤ 35 kg/m2
• Postmenopausal women (absence of menstrual cycle for at least 2 years)
• Willingness and ability to provide informed consent

You may not qualify if:

• Taking drugs that may interfere with muscle or bone metabolism,
• Evidence of diseases known to interfere with bone or muscle metabolism
• Rheumatoid arthritis
• Patients undergoing revision hip replacement surgery
• Presence of infection or suspicion of infection at the hip
• Inability to provide informed consent
• Previous synthetic surgery for proximal femur fractures
• Severe obesity (BMI \>35kg/m2)

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, 20173, Italy

RECRUITING

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Laura Mangiavini

  University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Mangiavini

CONTACT

0283506790; laura.mangiavini@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: March 22, 2024
• Study Start: February 7, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)