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

Plating of Acute Humeral Diaphyseal Fractures Via an Anterior Lateral Approach in Multiple Trauma Patients.

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.

Study Overview

• Status: Completed
• Conditions: Multiple Trauma; Humeral Fractures

• Study Type: Observational
• Enrollment (Actual): 96

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated by our practice for diaphyseal fracture of the humerus after multiple trauma.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
DASH (Disabilities of the Arm, Shoulder and Hand) Score	At Enrollment
Strength of injured arm compared to uninjured arm	At enrollment
Range of motion in injured arm compared to uninjured arm	At enrollment

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Idoine JD 3rd, French BG, Opalek JM, DeMott L. Plating of acute humeral diaphyseal fractures through an anterior approach in multiple trauma patients. J Orthop Trauma. 2012 Jan;26(1):9-18. doi: 10.1097/BOT.0b013e318214ebd5.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 21, 2008
• First Submitted That Met QC Criteria: July 21, 2008
• First Posted (Estimate): July 23, 2008

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Arm Injuries; Wounds and Injuries; Fractures, Bone; Multiple Trauma; Humeral Fractures
• Other Study ID Numbers: 08-0014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO