IlluminOss Hand Fracture International Clinical Feasibility Study

Orthopedic Fractures Clinical Trial

Official title:

IlluminOss Medical- Photodynamic Bone Stabilization System- International Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823251
• Other study ID #: ILLUM-OUS-2008-001
• Status: Completed
• Phase: Phase 1
• First received: December 30, 2008
• Last updated: June 6, 2017
• Start date: December 2008
• Est. completion date: February 2013

Study information

• Verified date: June 2017
• Source: IlluminOss Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: February 2013
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Orthopedic Fractures

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital del Trabajador	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
IlluminOss Medical, Inc.

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.		Immediately post-surgery
Secondary	Rate of Fracture Union		180 day
Secondary	Rate of Anatomic Alignment		180 Day
Secondary	Functionality Score		180 Day
Secondary	Grip Strength		180 Day
Secondary	Range of Motion		180 day
Secondary	Incidence of Reintervention of Target Fracture		180 Day
Secondary	Bone Pin Migration		180 Day
Secondary	Adverse Event Rate		180 day