NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures

Phase 4

• Conditions: Fracture
• Interventions: Device: NovaLign Intramedullary Fixation System

• Registration Number: NCT00969839
• Lead Sponsor: NovaLign Orthopaedics, Inc

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.

Study Timeline

• Study First Submitted: 2009-08-30
• Study First Submitted QC: 2009-08-31
• Status Verified: 2009-09
• Study Start: 2009-09
• Study First Posted: 2009-09-01
• Last Update Submitted: 2009-09-16
• Last Update Posted: 2009-09-18
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intramedullary Fixation System	NovaLign Intramedullary Fixation System	Humeral fractures to be treated with the Intramedullary Fixation System

Primary Outcome Measures

Name	Time	Method
Radiographic union and safety	12 months

Secondary Outcome Measures

Name	Time	Method
Function, pain, and quality of life assessments at regular intervals	12 months

Trial Locations

Locations (2)

University of Missouri - Columbia; 🇺🇸 Columbia, Missouri, United States

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States