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IlluminOss Hand Fracture International Clinical Feasibility Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823251
First Posted: January 15, 2009
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
IlluminOss Medical, Inc.
December 30, 2008
January 15, 2009
June 7, 2017
December 2008
October 2009   (Final data collection date for primary outcome measure)
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location. [ Time Frame: Immediately post-surgery ]
Not Provided
Complete list of historical versions of study NCT00823251 on ClinicalTrials.gov Archive Site
  • Rate of Fracture Union [ Time Frame: 180 day ]
  • Rate of Anatomic Alignment [ Time Frame: 180 Day ]
  • Functionality Score [ Time Frame: 180 Day ]
  • Grip Strength [ Time Frame: 180 Day ]
  • Range of Motion [ Time Frame: 180 day ]
  • Incidence of Reintervention of Target Fracture [ Time Frame: 180 Day ]
  • Bone Pin Migration [ Time Frame: 180 Day ]
  • Adverse Event Rate [ Time Frame: 180 day ]
Not Provided
Not Provided
Not Provided
 
IlluminOss Hand Fracture International Clinical Feasibility Study
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Orthopedic Fractures
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.
Experimental: IlluminOss device
IlluminOss bone-pin device
Intervention: Device: IlluminOss device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
February 2013
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
 
NCT00823251
ILLUM-OUS-2008-001
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
IlluminOss Medical, Inc.
IlluminOss Medical, Inc.
Not Provided
Not Provided
IlluminOss Medical, Inc.
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP