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Plating of Humeral Shaft Fractures in Multiple Trauma Patients. (HUMERUS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00720681
First Posted: July 23, 2008
Last Update Posted: March 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Orthopaedic Trauma and Reconstructive Surgery
Information provided by (Responsible Party):
Bruce French, OhioHealth
  Purpose
The purpose of this study is to review our experience with the operative management of acute diaphyseal fractures of the humerus via an anterolateral approach with the use of small fragment fixation at a Level I, urban, trauma center. We will report our clinical and radiographic results, complication rate and final range of motion. A standardized outcome measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be evaluated by a standard protocol, accomplished with the assistance of a licensed physical therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal fractures via an antero-lateral approach with the use of small fragment fixation is a safe and efficacious way to treat multiple trauma patients with these injuries.

Condition
Humeral Fractures Multiple Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Plating of Acute Humeral Diaphyseal Fractures Via an Anterior Lateral Approach in Multiple Trauma Patients.

Resource links provided by NLM:


Further study details as provided by Bruce French, OhioHealth:

Primary Outcome Measures:
  • DASH (Disabilities of the Arm, Shoulder and Hand) Score [ Time Frame: At Enrollment ]
  • Strength of injured arm compared to uninjured arm [ Time Frame: At enrollment ]
  • Range of motion in injured arm compared to uninjured arm [ Time Frame: At enrollment ]

Enrollment: 96
Study Start Date: August 2008
Study Completion Date: January 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated by our practice for diaphyseal fracture of the humerus after multiple trauma.
Criteria

Inclusion Criteria:

  • age > 18 years
  • patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF)
  • patients for whom the above fracture has healed
  • patients willing and able to provide informed consent and able to participate in study procedures

Exclusion Criteria:

  • patients with known pathological fractures
  • patients with metabolic bone disease
  • patients with humeral head or inter-articular surface fractures, or other upper extremity fractures
  • patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.)
  • patients with neurologic injury to upper extremities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720681


Sponsors and Collaborators
OhioHealth
Orthopaedic Trauma and Reconstructive Surgery
Investigators
Principal Investigator: Bruce French, M.D. Grant Medical Center
  More Information

Publications:
Responsible Party: Bruce French, Chief, OrthopedicTrauma, OhioHealth
ClinicalTrials.gov Identifier: NCT00720681     History of Changes
Other Study ID Numbers: 08-0014
First Submitted: July 21, 2008
First Posted: July 23, 2008
Last Update Posted: March 30, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Humeral Fractures
Multiple Trauma
Arm Injuries