Custom-made implants for massive acetabular bone loss: accuracy with CT assessment.
Matteo Romagnoli, Marco Zaffagnini, Eleonora Carillo...
https://pubmed.ncbi.nlm.nih.gov/37777776Actively Recruiting
Led by Istituto Ortopedico Rizzoli · Updated on 2026-02-23
15
Participants Needed
1
Research Sites
26 weeks
Total Duration
This research evaluates custom-made acetabular implants designed for adults undergoing revision hip surgery due to severe bone loss, specifically Paprosky 3 defects, for non-cancerous reasons. The study aims to validate this personalized implant technology made using additive manufacturing based on pre-operative CT scans to address challenges in complex hip revisions. It focuses on clinical and radiological outcomes, perioperative complications, and implant survival in patients with severe acetabular bone damage. Participants receive a custom implant tailored to their bone defect using a CT scan to create a personalized device with a porous surface to support bone integration. The implant is accompanied by specialized tools for surgery and produced by an external company following approved manufacturing practices. Preoperative evaluations include clinical scoring and bone loss assessment, with data collected on surgical complications and postoperative recovery. Participants attend follow-up visits at 1, 3, 12, 24, and 36 months after surgery for clinical and radiographic evaluations. Assessments include the Harris Hip Score, patient-reported outcomes, satisfaction levels, and detailed imaging to measure implant positioning and bone integration. Researchers track complications, implant stability, and revision rates, providing comprehensive monitoring of outcomes up to 18 months and beyond.
CONDITIONS
Innovative Technologies for Salvage Procedures of Failed Treatments of Osteoarthritis: Biomimetics Solutions (CustomPN)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical day and immediate post-operative period
Participants receive a custom-made acetabular implant designed to fill severe bone loss in hip revision surgery using additive manufacturing based on their pre-operative CT scan.
1 surgical visit (in-person)
Duration - Up to 36 months after surgery
Participants undergo clinical and radiographic evaluations to assess implant positioning, osteointegration, complications, and patient satisfaction after surgery.
Outpatient visits at 1, 3, 12, 24, and 36 months
Total: 1 location
1
Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
Bologna, Italy, 40136
Actively Recruiting
F
Francesco Castagnini, MD
F
Francesco Traina, Prof
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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