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

Summary

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.

Conditions

• Closed Fracture of Shaft of Humerus

Sponsors & Collaborators

• Boston Medical Center

  collaborator OTHER

• Inova Fairfax Hospital

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Prisma Health-Midlands

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Wake Forest University

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Lahey Clinic

  collaborator OTHER

• St. Louis University

  lead OTHER

Principal Investigators

• Lisa K Cannada, M.D. · St. Louis University

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2018-11-20

Completion

2018-11-20

Countries

• United States

Study Locations