IlluminOss Hand Fracture International Clinical Feasibility Study
Primary Purpose
Orthopedic Fractures
Status
Completed
Phase
Phase 1
Locations
Chile
Study Type
Interventional
Intervention
IlluminOss device
Sponsored by
About this trial
This is an interventional treatment trial for Orthopedic Fractures
Eligibility Criteria
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
Sites / Locations
- Hospital del Trabajador
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IlluminOss device
Arm Description
IlluminOss bone-pin device
Outcomes
Primary Outcome Measures
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.
Secondary Outcome Measures
Rate of Fracture Union
Rate of Anatomic Alignment
Functionality Score
Grip Strength
Range of Motion
Incidence of Reintervention of Target Fracture
Bone Pin Migration
Adverse Event Rate
Full Information
NCT ID
NCT00823251
First Posted
December 30, 2008
Last Updated
June 6, 2017
Sponsor
IlluminOss Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00823251
Brief Title
IlluminOss Hand Fracture International Clinical Feasibility Study
Official Title
IlluminOss Medical- Photodynamic Bone Stabilization System- International Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlluminOss Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IlluminOss device
Arm Type
Experimental
Arm Description
IlluminOss bone-pin device
Intervention Type
Device
Intervention Name(s)
IlluminOss device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.
Time Frame
Immediately post-surgery
Secondary Outcome Measure Information:
Title
Rate of Fracture Union
Time Frame
180 day
Title
Rate of Anatomic Alignment
Time Frame
180 Day
Title
Functionality Score
Time Frame
180 Day
Title
Grip Strength
Time Frame
180 Day
Title
Range of Motion
Time Frame
180 day
Title
Incidence of Reintervention of Target Fracture
Time Frame
180 Day
Title
Bone Pin Migration
Time Frame
180 Day
Title
Adverse Event Rate
Time Frame
180 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital del Trabajador
City
Santiago
Country
Chile
12. IPD Sharing Statement
Learn more about this trial
IlluminOss Hand Fracture International Clinical Feasibility Study
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