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

NCT01363518 | Completed DMC

• 1 other identifier: 16589
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 7

Brief 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. 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. 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. 3.Complication rates of infection and iatrogenic neurologic injury will be higher in patients treated operatively.
4. 4.Nonunion and malunion will be higher in patients managed conservatively.

Conditions

Closed Fracture of Shaft of Humerus

Keywords

humerus; fracture; operative treatment; non-operative treatment

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study is the Disability of Arm, Shoulder and Hand (DASH) score.

  10 units difference of DASH will be considered as a clinically meaning full difference. Based on previous studies, the standard deviation of DASH is around 20. With 64 subjects in each group (total 128), we will have 80% power to detect a difference in mean of 10 between two study arms assuming the common standard deviation is 20 using a student t-test with type I error rate 0.05.

  Enrollment, 12 Week, 6 Month, and 12 Month Follow-Ups

Study Arms (2)

Operative

Operative group would have had surgery to treat their broken humerus.

Nonoperative

Nonoperative group would have been treated with a brace, no surgery.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18 to 65 years with a humeral shaft fracture.

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

Sponsors & Collaborators

• St. Louis University: lead
• Boston Medical Center: collaborator
• Inova Fairfax Hospital: collaborator
• Indiana University: collaborator
• Prisma Health-Midlands: collaborator
• Vanderbilt University: collaborator
• Wake Forest University: collaborator
• University of North Carolina: collaborator
• Lahey Clinic: collaborator

Study Sites (7)

Indiana University-Wishard Hospital

Indianapolis, Indiana, 49053, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Inova Fairfax

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Lisa K Cannada, M.D.

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 1, 2011
• Study Start: May 1, 2010
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)