IlluminOss Hand Fracture International Clinical Feasibility Study

IlluminOss Medical

Status and phase

Completed

Phase 1

Conditions

Orthopedic Fractures

Treatments

Device: IlluminOss device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00823251

ILLUM-OUS-2008-001

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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