A Study to Evaluate the Safety and Effectiveness of the NovaLign Intramedullary Fixation System for the Treatment of Humeral Diaphysis Fractures

NovaLign Orthopaedics, Inc2 sites in 1 country20 target enrollmentSeptember 2009

ConditionsFracture

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Fracture
Sponsor: NovaLign Orthopaedics, Inc
Enrollment: 20
Locations: 2
Primary Endpoint: Radiographic union and safety
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.

Detailed Description

This is an observational, prospective, nonrandomized open label, post-market clinical study, designed to evaluate the use a flexible intramedullary fixation device used in the treatment of fractures of the humerus. This is a multicentre trial.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

March 2011

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

NovaLign Orthopaedics, Inc

Eligibility Criteria

Inclusion Criteria

•Humeral Fracture
•Surgical intervention can be performed within 14 days of injury (injury being Day 0 for this particular criteria)
•Fully functioning contralateral limb (e.g., hand, arm, shoulder)
•Age 18 years or older and skeletally mature

Exclusion Criteria

•Intraarticular fractures or those involving shoulder or elbow of the index arm
•Pathologic fracture (e.g., tumor involvement, osteomalacia, etc.; osteoporosis is not an exclusion)
•Evidence of neurologic injury in the index arm, including compartment syndrome or radial nerve palsy
•Additional upper body injuries (e.g., upper extremity, abdominal, thoracic, neck or head injury) that may affect or inhibit the evaluation of the index or contralateral arm, shoulder, elbow, etc or would not allow the patient to follow or comply with appropriate post-operative regimens
•Any previous bodily injury or surgery that may interfere with function or evaluation of index or contralateral arm, shoulder, elbow, etc.