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NCT02861495 · ClinicalTrials.gov registry record · NA

Humeral Compression/Distraction Device

A NA study, sponsored by Florida Orthopaedic Institute.

Terminated
Registry status
NA
Development phase
2
Enrollment target

NCT02861495: Clinical Trial NA study, sponsored by Florida Orthopaedic Institute.

NCT02861495 is a NA study that was terminated before completion, run by Florida Orthopaedic Institute. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02861495, a NA study, was terminated before completion, sponsored by Florida Orthopaedic Institute.

TERMINATED
Registry status
NA
Development phase
2 participants
Enrollment target

Study Summary

The proposed study of humeral shaft fractures in adults will examine outcomes in patients treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an internal gear system controlled wirelessly by rare earth magnets, which typically offers distraction for lengthening. In the humerus however, during the treatment of acute fractures, this percutaneously inserted nail can also offer compression during the healing process, thereby negating the effect of gravity, which may in turn lead to a faster and more consistent rate of union. Furthermore, in cases of slower healing the dynamic properties of the nail may employ an "accordion technique" (alternating compression-distraction, a feature unique to this implant.

Primary Outcome

Union rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.

Interventions

  • DEVICE Humeral Compression/Distraction (CD) Nail

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2016-09-30
Est. Completion 2018-08-15
Phase NA
Florida Orthopaedic Institute

5 total trials

Why NCT02861495 stopped before completion

NCT02861495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Humeral Compression/Distraction (CD) Nail is the first listed.

NCT02861495 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02861495 about?

NCT02861495 is a clinical study titled "Humeral Compression/Distraction Device". The proposed study of humeral shaft fractures in adults will examine outcomes in patients treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an internal gear system controlle...

What is the current status of trial NCT02861495?

This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2016-09-30. Estimated completion is 2018-08-15.

What interventions are being tested in trial NCT02861495?

The interventions under investigation include: Humeral Compression/Distraction (CD) Nail (DEVICE).

Who is sponsoring clinical trial NCT02861495?

This trial is sponsored by Florida Orthopaedic Institute, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02861495's enrollment target sits among peer trials

2 1997th of 2000 the lowest of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02861495, the US trial registry maintained by the National Library of Medicine. NCT02861495 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.