An interventional study of DXA in Bone Resorption and Arthroplasty Complications, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Recruiting at 1 site in Italy. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Not applicable, Interventional, and Diagnostic
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
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
167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.
This study's planned enrollment of 69 is above the median of 24 across 146 interventional studies indexed under Bone Resorption.
Browse Bone Resorption studies →I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who are candidates for elective hip arthroplasty surgery (indication determined only by the Orthopedic Surgeon)
Exclusion Criteria:
Taking drugs that may interfere with muscle or bone metabolism,
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This single group is composed by patients undergoing hip arthroplasty
Diagnostic Test: DXA
Patients will undergo a femoral and lumbar DXA
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.
Time frame: 12 months
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Oct 2024, 20 months after the start.
Of 82 non-industry interventional studies with no phase under Bone Resorption, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 20 months is below that.
Counting every sponsor, half of 83 studies reached it within 23 months; a quarter within 12 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio →