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

NovaLign Orthopaedics

Status and phase

Unknown

Phase 4

Conditions

Fracture

Treatments

Device: NovaLign Intramedullary Fixation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00969839

SP-001

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.