NCT06527664 Innovative Technologies for Salvage Procedures of Failed Treatments of Osteoarthritis: Biomimetics Solutions (CustomPN)
| NCT ID | NCT06527664 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Bone Loss |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2024-10-01 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Francesco Traina, Prof
PRINCIPAL INVESTIGATOR
IRCCS Istituto Ortopedico Rizzoli
Frequently Asked Questions
Who can join the NCT06527664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06527664 currently recruiting?
Yes, NCT06527664 is actively recruiting participants. Contact the research team at francescocastagnini@hotmail.it for enrollment information.
Where is the NCT06527664 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06527664 clinical trial?
NCT06527664 is sponsored by Istituto Ortopedico Rizzoli. The principal investigator is Francesco Traina, Prof at IRCCS Istituto Ortopedico Rizzoli. The trial plans to enroll 15 participants.