IlluminOss Hand Fracture International Clinical Feasibility Study

Phase 1

Completed

• Conditions: Orthopedic Fractures
• Interventions: Device: IlluminOss device

• Registration Number: NCT00823251
• Lead Sponsor: IlluminOss Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-30
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Primary Completion: 2009-10
• Study Completion: 2013-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IlluminOss device	IlluminOss device	IlluminOss bone-pin device

Primary Outcome Measures

Name	Time	Method
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.	Immediately post-surgery

Secondary Outcome Measures

Name	Time	Method
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
Incidence of Reintervention of Target Fracture	180 Day
Bone Pin Migration	180 Day
Adverse Event Rate	180 day

Trial Locations

Locations (1)

Hospital del Trabajador; 🇨🇱 Santiago, Chile