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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Orthopaedic Trauma and Reconstructive Surgery
Information provided by:
Grant Medical Center
ClinicalTrials.gov Identifier:
NCT00720681
First received: July 21, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  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 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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on October 16, 2014