Status:
COMPLETED
IlluminOss Hand Fracture International Clinical Feasibility Study
Lead Sponsor:
IlluminOss Medical, Inc.
Conditions:
Orthopedic Fractures
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00823251
Start Date
December 1 2008
End Date
February 1 2013
Last Update
June 7 2017
Active Locations (1)
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1
Hospital del Trabajador
Santiago, Chile