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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00969839

Enrollment

Registered

2009-09-01

Start date

2009-09-30

Completion date

2011-03-31

Last updated

2009-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture

Keywords

Fracture, Humerus, Intramedullary, Fixation

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.

Interventions

DEVICENovaLign Intramedullary Fixation System

Intramedullary fixation of broken humerus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Radiographic union and safety	12 months

Secondary

Measure	Time frame
Function, pain, and quality of life assessments at regular intervals	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026