Recruiting

NovaLign IFS

Sponsor:

NovaLign Orthopaedics, Inc

Code:

NCT00969839

Conditions

Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NovaLign Intramedullary Fixation System

Study Details

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.

Conditions

Fracture

Study ID

NCT00969839

Start date

Sep, 2009

Status verified date

Sep, 2009

Completion date

Mar, 2011

Anticipated

Primary completion date

Mar, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intramedullary Fixation System

Humeral fractures to be treated with the Intramedullary Fixation System

Interventions

NovaLign Intramedullary Fixation System

Intramedullary fixation of broken humerus

Primary outcome measure

  • Radiographic union and safety [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Denver Health Medical Center

Recruiting

Denver, Colorado, United States, 80204

Contacts

S Morgan, MD

303-602-3796

A Baron

(303) 602-3796

Principal Investigator:

S Morgan, MD

University of Missouri - Columbia

Recruiting

Columbia, Missouri, United States, 65212

Contacts

B Crist, MD

573-884-0854

L Anderson, RN

(573) 884-0854

Principal Investigator:

B Crist, MD

More Information

Sponsor

NovaLign Orthopaedics, Inc

Last update posted

Sep 18, 2009

Last verified

Sep, 2009

Keywords

  • Fracture
  • Humerus
  • Intramedullary
  • Fixation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NovaLign Orthopaedics, Inc on 2009-09-18.