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Clinical Trials/NCT00720681
NCT00720681
Completed
Not Applicable

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

OhioHealth0 sites96 target enrollmentAugust 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Humeral Fractures
Sponsor
OhioHealth
Enrollment
96
Primary Endpoint
DASH (Disabilities of the Arm, Shoulder and Hand) Score
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
January 2012
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
OhioHealth
Responsible Party
Principal Investigator
Principal Investigator

Bruce French

Chief, OrthopedicTrauma

OhioHealth

Eligibility 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

Outcomes

Primary Outcomes

DASH (Disabilities of the Arm, Shoulder and Hand) Score

Time Frame: At Enrollment

Range of motion in injured arm compared to uninjured arm

Time Frame: At enrollment

Strength of injured arm compared to uninjured arm

Time Frame: At enrollment

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