Operative Versus Nonoperative Treatment of Humeral Shaft Fractures: A Prospective Cohort Comparison Study

Completed

Conditions studied: Closed Fracture of Shaft of Humerus

In brief

The subject's broken humerus (arm) is suitable for treatment with a fracture brace or operative fixation with plate and screws. Both of these types of treatments are often used by doctors to fix broken bones. If the subject agrees to participate in this study, the subject will be assigned by the treating surgeon to one of the following groups: Group B: Non-operative treatment with a fracture brace Group P: a plate \& screws - a metal device placed on top of the bone. The investigators will collect information about the subject's arm fracture as it is treated with examinations and X-rays. X-rays will be obtained often in the first several months, depending on how the fracture is healing. This is determined by the doctor and will not be determined by the subject's participation in this research study. Both treatments are routinely used and this study hopes to provide information regarding each type of treatment on the subject's functional outcome. A subject's treatment will not be affected whether they choose to participate in this research study or not. The treatment of these subjects is no different because of this study. The treating surgeon will discuss with the patient their preferred treatment for the isolated humeral shaft fracture. If they meet the inclusion/exclusion criteria, they will be approached for participation in one of two treatment groups depending on a previous decision by the patient and the treating surgeon. Hypotheses: 1. Patients with an isolated humeral shaft fracture that are plated will have a more rapid return to ADL's, work and full functional capacity than patients treated conservatively. 2. Patients treated with plate technique will have a more rapid improvement in functional outcome scores, decreased pain scores and patient satisfaction than those managed conservatively. 3. Complication rates of infection and iatrogenic neurologic injury will be higher in patients treated operatively. 4. Nonunion and malunion will be higher in patients managed conservatively.

Key facts

Study ID

NCT01363518

Run by

St. Louis University

People needed

164

Starts

2010-05-01

Expected to finish

2018-11-20

Last updated by the study team

2019-05-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of a closed, humeral shaft fracture
• English Speaking
• Age between 18-65 at the time of injury
• Entry into the study within 2 weeks of injury
• Available for follow-up for at least 12 months
• Patient signs informed consent

You may not qualify if…

• Age less than 18 or greater than 65 at time of injury
• Patients who are skeletally immature
• Humeral shaft fractures that extend into the articular surface
• Open humeral shaft fractures
• Additional long bone injuries of upper or lower extremity that would compromise outcome assessment
• Vascular injury requiring repair
• Pathologic fracture
• Definitive treatment delay of more than 2 weeks from initial injury
• Immunocompromised patient
• Unable to comply with post-operative rehabilitation protocols or instructions
• Current or impending incarceration
• Unlikely to follow-up in surgeon's estimation
• Pregnant or lactating female
• Previous retained hardware in humeral shaft

Where it is running

• Indiana University-Wishard Hospital — Indianapolis, Indiana, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Inova Fairfax — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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