Rare Disease Trial, Completed NCT05612139 Sponsor: Orthofix s.r.l. Condition: Rare Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial involved 14 participants, all of whom completed the study with no dropouts. The trial was examining a device called JTIN — an intramedullary nail (a rod inserted into the bone) — and was looking at how often unwanted medical events occurred during procedures involving it, as well as several measures related to how the implant and the treated bones performed over the follow-up period. The reported data shows that in 4% of procedures, at least one adverse event (an unwanted medical occurrence) that was considered certainly or possibly related to JTIN was recorded. On the secondary measures, the reported data shows that 100% of the implanted nails remained in place without needing to be surgically replaced, and bone union (where the treated bone knitted back together) was reported to have been achieved in 100% of procedures. For the measure described as "post-treatment fracture-free survival" — meaning the proportion of patients who did not experience a new fracture in the treated bone during the follow-up period — the reported figure was 35.7%. The trial's reporting does not clarify over what specific timeframe this last figure was measured. It is worth noting that this was a small study of only 14 people, and the results reported here are those submitted by the trial sponsor to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Rare Disease Trial, Completed

NCT05612139
Completed Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • 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

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 18 August 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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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 was run

🇫🇷 France

These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

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

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 18 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov