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.
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.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, 20173
Laura Mangiavini, 0283506790, laura.mangiavini@unimi.it
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
- Conditions
- Bone Resorption, Arthroplasty Complications
- 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 group | Role | What they receive |
|---|---|---|
| Hip arthroplasty group | Experimental | This 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.
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)
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
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
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
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
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
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.
- First posted22 Mar 2024
- Study start7 Feb 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Mangiavini, Principal investigator, University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finite-element Analysis Based on Computed Bone Mineralometry (DXA) as an Aid to Pre and Post Assessment in Hip Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT06324708
- Acronym / sponsor ID
- THA_DXA / THA_DXA
- Conditions
- Bone Resorption, Arthroplasty Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip arthroplasty group | Experimental | Diagnostic Test: DXAThis single group is composed by patients undergoing hip arthroplasty |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXAPatients will undergo a femoral and lumbar DXA | Diagnostic test | Hip arthroplasty group |
Primary outcome
Role of two-dimensional FEM models obtained from DXA images in longitudinal evaluation of periprosthetic bone
Time frame: 12 months
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.
6 secondary outcomes
Role of two-dimensional FEM models of bone resistance to loading
Time frame: 12 months
Identification of mechanical stress
Time frame: 12 months
Assesment with PROMs: VAS
Time frame: 12 months
Assesment with PROMs; HHS
Time frame: 12 months
Assesment with PROMs: SF12
Time frame: 12 months
Assesment with PROMs: HOOS PS
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Mangiavini principal investigator
University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio
1 site in 1 country: see every site and its status.
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.