Plating of Humeral Shaft Fractures in Multiple Trauma Patients.

Multiple Trauma Clinical Trial

— HUMERUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720681
• Other study ID #: 08-0014
• Status: Completed
• Phase: N/A
• First received: July 21, 2008
• Last updated: March 28, 2016
• Start date: August 2008
• Est. completion date: January 2012

Study information

• Verified date: March 2016
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 2012
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Multiple Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
OhioHealth	Orthopaedic Trauma and Reconstructive Surgery

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH (Disabilities of the Arm, Shoulder and Hand) Score		At Enrollment	No
Primary	Strength of injured arm compared to uninjured arm		At enrollment	No
Primary	Range of motion in injured arm compared to uninjured arm		At enrollment	No