Plating of Humeral Shaft Fractures in Multiple Trauma Patients. - Full Text View

Sponsors and Collaborators:	Grant Medical Center Orthopaedic Trauma and Reconstructive Surgery
Information provided by:	Grant Medical Center
ClinicalTrials.gov Identifier:	NCT00720681

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:	Cohort, Cross-Sectional
Official Title:	Plating of Acute Humeral Diaphyseal Fractures Via an Anterior Lateral Approach in Multiple Trauma Patients.

Resource links provided by NLM:

MedlinePlus related topics: Fractures Injuries Wounds

U.S. FDA Resources

Further study details as provided by Grant Medical Center:

Primary Outcome Measures:

DASH (Disabilities of the Arm, Shoulder and Hand) Score [ Time Frame: At Enrollment ] [ Designated as safety issue: No ]
Strength of injured arm compared to uninjured arm [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
Range of motion in injured arm compared to uninjured arm [ Time Frame: At enrollment ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	August 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720681

Sponsors and Collaborators

Grant Medical Center

Orthopaedic Trauma and Reconstructive Surgery

Investigators

Principal Investigator:

Bruce French, M.D.

Grant Medical Center

More Information

No publications provided

Responsible Party:	Orthopaedic Trauma and Reconstructive Surgery ( Bruce French, M.D. )
Study ID Numbers:	08-0014
Study First Received:	July 21, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00720681 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Multiple Trauma
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Humeral Fractures
Arm Injuries

Additional relevant MeSH terms:

Multiple Trauma
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Humeral Fractures
Arm Injuries

ClinicalTrials.gov processed this record on September 09, 2009