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

Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00969839
• Other study ID #: SP-001
• Status: Recruiting
• Phase: Phase 4
• First received: August 30, 2009
• Last updated: September 16, 2009
• Start date: September 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2009
• Source: NovaLign Orthopaedics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Intervention

Device:
• NovaLign Intramedullary Fixation System
Intramedullary fixation of broken humerus

Locations

Country	Name	City	State
United States	University of Missouri - Columbia	Columbia	Missouri
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
NovaLign Orthopaedics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic union and safety		12 months	Yes
Secondary	Function, pain, and quality of life assessments at regular intervals		12 months	No