IlluminOss Hand Fracture International Clinical Feasibility Study

June 6, 2017 updated by: IlluminOss Medical, Inc.

IlluminOss Medical- Photodynamic Bone Stabilization System- International Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Hospital del Trabajador

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IlluminOss device
IlluminOss bone-pin device
Device: IlluminOss 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.
Time Frame: Immediately post-surgery
Immediately post-surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of Fracture Union
Time Frame: 180 day
180 day
Rate of Anatomic Alignment
Time Frame: 180 Day
180 Day
Functionality Score
Time Frame: 180 Day
180 Day
Grip Strength
Time Frame: 180 Day
180 Day
Range of Motion
Time Frame: 180 day
180 day
Incidence of Reintervention of Target Fracture
Time Frame: 180 Day
180 Day
Bone Pin Migration
Time Frame: 180 Day
180 Day
Adverse Event Rate
Time Frame: 180 day
180 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IlluminOss Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

December 30, 2008

First Submitted That Met QC Criteria

January 14, 2009

First Posted (ESTIMATE)

January 15, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILLUM-OUS-2008-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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