Innovative Technologies for Salvage Procedures of Failed Treatments of Osteoarthritis: Biomimetics Solutions (CustomPN)
Key facts
- Where
- Bologna, ItalySee the site
Where in Italy
- Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyBologna, ItalyContact: Francesco Castagnini, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Istituto Ortopedico Rizzoli
- Trial code
- NCT06527664
- Record updated
- 23 February 2026
- Original description
In this prospective multicenter study, a population of adult individuals consecutively treated for revision hips, requiring a custom-made acetabular implant for non-oncological reasons, will be included. The custom-made implant is a personalized implant produced using additive manufacturing, based on the pre-operative CT scan that details the bone damage. Patients eligible for this implant are those with severe acetabular bone damage Paprosky 3 (loss of the superolateral part and one of the two ventro-caudal walls).Read full original descriptionShow less
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)
In this prospective multicenter study, a population of adult individuals consecutively treated for revision hips, requiring a custom-made acetabular implant for non-oncological reasons, will be included. The custom-made implant is a personalized implant produced using additive manufacturing, based on the pre-operative CT scan that details the bone damage. Patients eligible for this implant are those with severe acetabular bone damage Paprosky 3 (loss of the superolateral part and one of the two ventro-caudal walls).
Preoperatively, the patient will undergo a clinical evaluation. Data will be collected on the patient's general health status with the Charlson score, the reason for revision, number of revisions, type of implant in place, and the time elapsed between the failed implant and the revision in question. The bone deficit will be studied through CT measurements according to qualitative and quantitative scales. During the surgery, information on intraoperative complications will be collected. In the postoperative period, perioperative complications will be collected according to the Clavien Dindo classification. The clinical radiographic evaluations will be carried out during outpatient follow-up visits at 1, 3, 12, 24, and 36 months after revision. They include the Harris Hip Score clinical score, the EQ-5D PROM, and the patient's satisfaction level (qualitative assessment in 4 grades: unsatisfied, slightly satisfied, moderately satisfied, fully satisfied). The positional parameters of the implant will be evaluated, as compared to the immediate post-operative X-ray: acetabular abduction, acetabular anteversion, center of rotation height, center of rotation medialization, and inclination of the custom-made component. From 12 months onwards, the osteointegration characteristics of the component will be assessed: presence of radial trabeculae at the interface, superolateral and inferior reinforcements, stress shielding, absence of radiolucent lines. Re-revision rates will be determined using the Kaplan-Meier method. The reasons for re-revision will be noted.
Inclusion: 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: other types of revision implant (non custom); oncological reasons for revision; inadequate medical chart; lack of pre-operative CT scan.