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CompletedNCT00823251Updated Jun 7, 2017

IlluminOss Hand Fracture International Clinical Feasibility Study

A Phase 1 interventional study of IlluminOss device in Orthopedic Fractures, sponsored by IlluminOss Medical, Inc.. Completed at 1 site in Chile. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-06-07.

Sponsored by IlluminOss Medical, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand.

02

Conditions studied

  • Orthopedic Fractures
03

In context

Lead sponsor

IlluminOss Medical, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Skeletally mature
  • Patient or his/her legal guardian understands the nature of the procedure and is willing to comply with associated follow-up evaluations, and provides written informed consent prior to the procedure
  • Female patients must be of non-child bearing potential, or have a negative pregnancy test within prior 48 hours
  • Acute fracture of metacarpal or phalangeal bone(s) that requires reduction and internal fixation
  • Fracture has occurred within past 3 weeks
  • Fracture types: transverse, short oblique, or any fracture pattern in which the comminuted segment is equal to or less than the diameter of the bone at fracture site

Exclusion criteria

Exclusion Criteria:

  • Patient is pregnant, lactating or female patients who intend to become pregnant during the course of the study
  • Patient has experienced a crush, mangling, or burn type injury
  • Patient has probable history of infection or confirmed infection at baseline
  • Patient has previous diagnosis of a significant bone disorder that may impair bone healing
  • Patient has a life expectancy of \< 26 weeks
  • Pathological fracture secondary to tumor
  • Open fracture of Gustilo-Anderson Type II or III
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    IlluminOss device

    IlluminOss bone-pin device

    Device: IlluminOss device

Interventions

  • DeviceIlluminOss device

    The IlluminOss™ Bone Stabilization System is designed to deliver the device to the fracture site via the medullary canal of the bone using percutaneous techniques. Once the device is in place and has spanned the fracture site, the device is expanded and hardened to reduce and stabilize the fracture, to aid in the support and healing of the bone fracture by primary callous formation and remodeling.

06

What researchers measure

Primary outcomes

  1. Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.

    Time frame: Immediately post-surgery

Secondary outcomes

  1. Rate of Fracture Union

    Time frame: 180 day

  2. Rate of Anatomic Alignment

    Time frame: 180 Day

  3. Functionality Score

    Time frame: 180 Day

  4. Grip Strength

    Time frame: 180 Day

  5. Range of Motion

    Time frame: 180 day

  6. Incidence of Reintervention of Target Fracture

    Time frame: 180 Day

  7. Bone Pin Migration

    Time frame: 180 Day

  8. Adverse Event Rate

    Time frame: 180 day

07

Study locations

1 site
  • Hospital del Trabajador
    Santiago, Chile
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00823251
Lead sponsor
IlluminOss Medical, Inc.
Responsible party
Sponsor
First posted
Jan 15, 2009
Start date
Dec 2008
Primary completion
Oct 2009
Completion
Feb 2013
Last update
Jun 7, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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