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

Primary Purpose

Fracture

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NovaLign Intramedullary Fixation System
Sponsored by
NovaLign Orthopaedics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture focused on measuring Fracture, Humerus, Intramedullary, Fixation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Denver Health Medical CenterRecruiting
  • University of Missouri - ColumbiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intramedullary Fixation System

Arm Description

Humeral fractures to be treated with the Intramedullary Fixation System

Outcomes

Primary Outcome Measures

Radiographic union and safety

Secondary Outcome Measures

Function, pain, and quality of life assessments at regular intervals

Full Information

First Posted
August 30, 2009
Last Updated
September 16, 2009
Sponsor
NovaLign Orthopaedics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00969839
Brief Title
NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures
Official Title
A Study to Evaluate the Safety and Effectiveness of the NovaLign Intramedullary Fixation System for the Treatment of Humeral Diaphysis Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
NovaLign Orthopaedics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture
Keywords
Fracture, Humerus, Intramedullary, Fixation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intramedullary Fixation System
Arm Type
Experimental
Arm Description
Humeral fractures to be treated with the Intramedullary Fixation System
Intervention Type
Device
Intervention Name(s)
NovaLign Intramedullary Fixation System
Intervention Description
Intramedullary fixation of broken humerus
Primary Outcome Measure Information:
Title
Radiographic union and safety
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Function, pain, and quality of life assessments at regular intervals
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B Crist, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Morgan, MD
Phone
303-602-3796
First Name & Middle Initial & Last Name & Degree
A Baron
Phone
(303) 602-3796
First Name & Middle Initial & Last Name & Degree
S Morgan, MD
Facility Name
University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B Crist, MD
Phone
573-884-0854
First Name & Middle Initial & Last Name & Degree
L Anderson, RN
Phone
(573) 884-0854
First Name & Middle Initial & Last Name & Degree
B Crist, MD

12. IPD Sharing Statement

Learn more about this trial

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

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