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Bone ResorptionTHA_DXANCT06324708

Analysis of Defined Elements on DXA in Patients Undergoing Hip Arthroplasty

A study testing DXA in people with Bone Resorption and Arthroplasty Complications, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Bone Resorption, Arthroplasty Complications
What is being tested?
DXA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteItaly
Study dates
7 Feb 2023to 31 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • 18 ≤ 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Laura Mangiavini contact

0283506790

laura.mangiavini@unimi.it

Italy1 site, 1 recruiting
  • IRCCS Ospedale Galeazzi-Sant'Ambrogio

    Milan, 20173

    Laura Mangiavini, 0283506790, laura.mangiavini@unimi.it

    Recruiting

Other trials in Italy

About this study

Official title: Finite-element Analysis Based on Computed Bone Mineralometry (DXA) as an Aid to Pre and Post Assessment in Hip Arthroplasty Surgery

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

Read the detailed description

Hip osteoarthritis is nowadays one of the most prevalent diseases in developed countries. Prosthetic replacement of the degenerated joint is the definitive treatment for more advanced stages of osteoarthritis.

Despite continuous improvements in prosthesis material, design, and implantation procedures that have led to a percentage reduction in failures, there is still an albeit low risk of hip prosthetic implantation failure today.

Preoperative planning is therefore a prerequisite in order to ensure the success of the implant and its longterm survival. This is generally based on radiographic investigations, with implant selection being based on "templating" the radiographs to replicate the patient's joint anatomy.

However, with preoperative radiographs (or possibly second-level investigations such as CT scans), only the geometry of the bone subjected to the implant through is evaluated, without obtaining information regarding the bone density or the load to which the implant will be subjected. However, the long-term stability of the implant depends on the load transfer to the adjacent bone. Non-physiological load transfer can cause stress-shielding, bone resorption, or fibrous tissue growth due to high micromovements at the implant-bone interface.

The study of images by finite element analysis (FEA) has been used in orthopedic biomechanics for fifty years, and the techniques have progressively evolved in terms of sophistication and ability to assess the postoperative mechanical environment The Bone Strain Index (BSI) software, obtained from computerized bone mineral imaging (DXA) surveys using FEA, automatically calculates the deformations and stresses to which a given bone segment is subjected from patient-specific loading conditions. Previous studies have evaluated changes in periprosthetic bone mineral density (BMD) around hip replacement, noting densitometric changes that could vary between subjects and as a function of treatment, suggesting periprosthetic DXA as a useful technique in early assessment of possible bone loss from periprosthetic resorption. However, there are no DXA-based studies in the literature that correlate BMD changes to periprosthetic mechanical stress.

In this study, the investigators aim to study periprosthetic hip bone by DXA technique, applying the FEA method to obtain two-dimensional models of bone resistance to loading, using BSI software.

This evaluation will be included in the context of the normal pre- and postoperative evaluation process, with a view to better understanding the therapeutic outcome and possibly providing a means of predicting early mobilization and thus possible surgical failure.

Patients will be recruited as part of the normal surgical procedure for patients referred for hip replacement surgery to be performed at the Galeazzi - Sant'Ambrogio Hospital. Subjects, after being informed about the study and giving their written informed consent, will provide the examining physician with the information needed to fill out appropriate biographical and medical history forms. Recruitment will be entrusted to the physicians who will perform routine clinical examinations.

Once enrolled, patients will have a lumbar and femoral DXA scan as a preoperative preliminary investigation; anthropometric evaluations, postoperative DXA scans (immediate postoperative and at 3,6,12 months), blood draws, and PROMs will be administered for each patient. The study will be conducted according to the guidelines of Good Clinical Practices

Being tested
DXA
Medical subject headings
Bone Resorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DXADiagnostic test

    Patients will undergo a femoral and lumbar DXA

Study groups in NCT06324708
Study groupRoleWhat they receive
Hip arthroplasty groupExperimentalThis single group is composed by patients undergoing hip arthroplasty
Receives: Diagnostic Test: DXA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (6)
  1. Role of two-dimensional FEM models of bone resistance to loading

    To investigate the role of two-dimensional FEM models of bone resistance to loading, obtained from DXA scans using BSI software in various femoral and acetabular periprosthetic regions.

    Measured: 12 months

  2. Identification of mechanical stress

    To identify, by joint assessment of BMD and BSI, which periprosthetic regions are most subjected to mechanical stress by virtue of the presence of the prosthesis, in order to predict possible excessive periprosthetic bone resorption

    Measured: 12 months

  3. Assesment with PROMs: VAS

    Assessment of patients' health status through the collection of visual analogue scale (VAS). Will be used a linear scale with no pain at the left border and very serious pain at the right border

    Measured: 12 months

  4. Assesment with PROMs; HHS

    Assessment of patients' health status through the collection of Harris Hip Score (HHS). The score is composed by question with multiple choice. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

    Measured: 12 months

  5. Assesment with PROMs: SF12

    Assessment of patients' health status through the collection of SF12. The SF-12 is made up of 4 scales (physical functioning, role and physical health, role and emotional state, mental health) measured by 2 items each and 4 scales each measured by one item (physical pain, vitality, social activities and general health).

    Measured: 12 months

  6. Assesment with PROMs: HOOS PS

    Assessment of patients' health status through the collection of Hip Disability and Osteoarthritis Outcome Score (HOOS PS). The questionnaire includes just 5 items with 5 response options each. Only one answer can be selected. Each of the items is scored from 0 (no health problems) to 4 (severe health problems). A raw score is generated by summing up all points of the 5 answers (maximum raw score = 20).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2024
  2. Study start7 Feb 2023
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06324708
Sponsor's protocol ID
THA_DXA
Acronym
THA_DXA
Status last verified
Jan 2024
First submitted
16 Jan 2024
Last updated
22 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DXA in people with Bone Resorption and Arthroplasty Complications, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Laura Mangiavini (0283506790, laura.mangiavini@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Role of two-dimensional FEM models obtained from DXA images in longitudinal evaluation of periprosthetic bone (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

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