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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intramedullary Fixation System

Humeral fractures to be treated with the Intramedullary Fixation System

Group Type EXPERIMENTAL

NovaLign Intramedullary Fixation System

Intervention Type DEVICE

Intramedullary fixation of broken humerus

Interventions

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NovaLign Intramedullary Fixation System

Intramedullary fixation of broken humerus

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No