IlluminOss Hand Fracture International Clinical Feasibility Study

NCT ID: NCT00823251

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IlluminOss device

IlluminOss bone-pin device

Group Type: EXPERIMENTAL

IlluminOss device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IlluminOss Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital del Trabajador

Santiago, , Chile

Countries

Chile

Other Identifiers

ILLUM-OUS-2008-001

Identifier Type: -

Identifier Source: org_study_id