NCT00969839

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

1.5 years

First QC Date

August 30, 2009

Last Update Submit

September 16, 2009

Conditions

Fracture

Keywords

FractureHumerusIntramedullaryFixation

Outcome Measures

Primary Outcomes (1)

  • Radiographic union and safety

    12 months

Secondary Outcomes (1)

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

    12 months

Study Arms (1)

Intramedullary Fixation System

EXPERIMENTAL

Humeral fractures to be treated with the Intramedullary Fixation System

Device: NovaLign Intramedullary Fixation System

Interventions

NovaLign Intramedullary Fixation SystemDEVICE

Intramedullary fixation of broken humerus

Intramedullary Fixation System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Intraarticular fractures or those involving shoulder or elbow of the index arm
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Denver Health Medical Center

Denver, Colorado, 80204, United States

RECRUITING

University of Missouri - Columbia

Columbia, Missouri, 65212, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • B Crist, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2009

First Posted

September 1, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

US(2)