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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT05612139

NCT05612139
Completed Not Applicable

Who may be able to join

Who might be able to join this trial:

  • You are a child or teenager older than 18 months and younger than 18 years old at the time of surgery
  • Your bones are still growing (you have not reached full skeletal maturity)
  • You have been diagnosed with Osteogenesis Imperfecta (OI), sometimes called "brittle bone disease"
  • Your doctor has already recommended surgery using a specific type of telescoping nail (JTIN) to treat a broken bone, bone realignment, or a bone that has not healed properly in the thigh or shin
  • You (and/or your parent or legal guardian) have been fully informed about the trial and agree to take part

Who may not be able to join:

  • You have a health condition that the manufacturer of the device says means it should not be used for you (confirm with trial site)
  • You have any other condition that the trial doctor believes could make it unsafe for you to participate or could affect how the study runs
  • You currently have, or would need, another implanted device that cannot safely be removed (with some exceptions — confirm with trial site)
  • You are currently in another clinical trial, or have taken part in one in the last 3 months — unless it was a genetics study related to OI that did not involve any new treatment, drug, or device
  • The trial doctor thinks it is likely you would not be able to attend all the required follow-up visits

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Orthofix s.r.l.
Registry
clinicaltrials_gov
Start date
27 August 2024
Est. completion
20 February 2025

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Percentage of Procedures With at Least One Serious/Not Serious Adverse Event Certainly or Possibly Related to JTIN

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov