IlluminOss Hand Fracture International Clinical Feasibility Study

NCT00823251 | Completed Phase 1

• 1 other identifier: ILLUM-OUS-2008-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Fractures

Outcome Measures

Primary Outcomes (1)

• Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.

  Immediately post-surgery

Secondary Outcomes (8)

• Rate of Fracture Union

  180 day

• Rate of Anatomic Alignment

  180 Day

• Functionality Score

  180 Day

• Grip Strength

  180 Day

• Range of Motion

  180 day

Study Arms (1)

IlluminOss device

EXPERIMENTAL

IlluminOss bone-pin device

Device: IlluminOss device

Interventions

IlluminOss device 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.

IlluminOss device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IlluminOss Medical, Inc.: lead

Study Sites (1)

Hospital del Trabajador

Santiago, Chile

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2008
• First Posted: January 15, 2009
• Study Start: December 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: February 1, 2013
• Last Updated: June 7, 2017

Record last verified: 2017-06

Locations

CL (1)