IlluminOss Hand Fracture International Clinical Feasibility Study

Tracking Information
First Submitted Date ICMJE	December 30, 2008
First Posted Date ICMJE	January 15, 2009
Last Update Posted Date	June 7, 2017
Study Start Date ICMJE	December 2008
Actual Primary Completion Date	October 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 6, 2017)	Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location. [ Time Frame: Immediately post-surgery ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00823251 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 6, 2017)	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 ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	IlluminOss Hand Fracture International Clinical Feasibility Study
Official Title ICMJE	IlluminOss Medical- Photodynamic Bone Stabilization System- International Study
Brief 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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Orthopedic Fractures
Intervention ICMJE	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.
Study Arms	Experimental: IlluminOss device; IlluminOss bone-pin device; Intervention: Device: IlluminOss device
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 6, 2017)	4
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	February 2013
Actual Primary Completion Date	October 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Chile
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00823251
Other Study ID Numbers ICMJE	ILLUM-OUS-2008-001
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Not Provided
Responsible Party	IlluminOss Medical, Inc.
Study Sponsor ICMJE	IlluminOss Medical, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	IlluminOss Medical, Inc.
Verification Date	June 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP