Investigating bone health in patients undergoing hip replacement surgery
Finite-element Analysis Based on Computed Bone Mineralometry (DXA) as an Aid to Pre and Post Assessment in Hip Arthroplasty Surgery
This study is testing how changes in bone health after hip replacement surgery can affect the success of the implants over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06324708 on ClinicalTrials.gov |
What this trial studies
This study examines the role of two-dimensional finite element models derived from DXA images to assess changes in bone mineral density and bone strain index in patients undergoing hip arthroplasty. It aims to evaluate the densitometric variations of these parameters over time, starting from immediately after surgery and continuing through a six-month follow-up. The research focuses on understanding how these changes in periprosthetic bone may influence the long-term success of hip implants. By utilizing advanced imaging techniques, the study seeks to improve preoperative planning and postoperative outcomes for patients.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 to 90 years with noninflammatory degenerative hip joint disease who are scheduled for elective hip arthroplasty.
Not a fit: Patients with rheumatoid arthritis, severe obesity, or those undergoing revision hip replacement surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of bone health around hip implants, potentially leading to improved surgical outcomes and reduced complications.
How similar studies have performed: While finite element analysis has been used in orthopedic biomechanics for decades, this specific application in assessing periprosthetic bone health is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Where this trial is running
Milan
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Laura Mangiavini — University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio
- Study coordinator: Laura Mangiavini
- Email: laura.mangiavini@unimi.it
- Phone: 0283506790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.