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OpenTrials
Completed

NCT Number: NCT00720681

Plating of Humeral Shaft Fractures 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: At Enrollment

  2. Strength of injured arm compared to uninjured arm

    Time frame: At enrollment

  3. Range of motion in injured arm compared to uninjured arm

    Time frame: At enrollment

Sponsors and collaborators

Lead sponsor

OhioHealth

Other

Collaborators

  • Orthopaedic Trauma and Reconstructive Surgery

Registry information

Official study title

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

Acronym: HUMERUS

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Jul 23, 2008
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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