Custom-made implants for failed hip surgeries
Innovative Technologies for Cost-Effective Healthcare Delivery for Salvage Procedures of Failed Treatments of Osteoarthritis: Specific Biomimetics Solutions to Reduce a Growing Problem With a High Social and Economic Impact.(CustomPN)
Istituto Ortopedico Rizzoli · NCT06527664
This study is testing whether custom-made hip implants can help adults who need surgery to fix problems from previous hip surgeries due to severe bone damage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06527664 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adult patients requiring revision hip arthroplasty due to severe acetabular bone damage. Participants will receive a personalized acetabular implant created using additive manufacturing, tailored to their specific bone structure as determined by pre-operative CT scans. The study will collect data on patients' health status, reasons for revision, and intraoperative complications to evaluate the effectiveness of these custom implants in improving surgical outcomes. The goal is to address the challenges posed by traditional off-the-shelf implants in cases of significant bone loss.
Who should consider this trial
Good fit: Ideal candidates are adults with severe acetabular bone damage requiring a custom-made implant for non-oncological reasons.
Not a fit: Patients needing revision for oncological reasons or those who do not require a custom implant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the outcomes of revision hip surgeries and enhance patients' quality of life.
How similar studies have performed: While custom implants have been explored in other contexts, this specific application using additive manufacturing for severe acetabular damage is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * need of custom-made acetabular implant on the basis of CT and X-ray evaluation () * pre-operative CT scan * adults patients (minimum age: 18 years) * complete medical charts * patients' availability Exclusion Criteria: * oncological reasons for revision * other types of revision implant (non custom) * inadequate medical chart * lack of pre-operative CT scan
Where this trial is running
Bologna
- Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy — Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Francesco Traina, Prof — IRCCS Istituto Ortopedico Rizzoli
- Study coordinator: Francesco Castagnini, MD
- Email: francescocastagnini@hotmail.it
- Phone: +390516366418
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.
Conditions: Bone Loss, Hip Prosthesis Infection, Arthroplasty Complications, revision hip arthroplasty, custom-made implant, additive manufacturing