Actively Recruiting

Age: 18Years +
All Genders
ID06527664

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)

Led by Istituto Ortopedico Rizzoli · Updated on 2026-02-23

15

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Innovative Technologies for Salvage Procedures of Failed Treatments of Osteoarthritis: Biomimetics Solutions (CustomPN)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Need for a custom-made acetabular implant based on CT and X-ray evaluation
  • Pre-operative CT scan available
  • Adult patients aged 18 years or older
  • Complete medical charts available
  • Patient is available and willing to participate
Not Eligible

You will not qualify if you...

  • Revision surgery for oncological reasons
  • Use of non-custom revision implants
  • Incomplete or inadequate medical records
  • Lack of pre-operative CT scan

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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)

Post-operative Follow-up

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

Trial Site Locations

Total: 1 location

1

Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy

Bologna, Italy, 40136

Actively Recruiting

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Research Team

F

Francesco Castagnini, MD

F

Francesco Traina, Prof

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

lsolated acetabular revisions of articular surface replacement (ASR) XL implants with highly porous titanium cups and Delta bearings.

Francesco Castagnini, Federica Mariotti, Enrico Tassinari...

https://pubmed.ncbi.nlm.nih.gov/31480877