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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363518
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : May 2, 2019
Sponsor:
Collaborators:
Boston Medical Center
Inova Fairfax Hospital
Indiana University
Prisma Health-Midlands
Vanderbilt University
Wake Forest University
University of North Carolina
Lahey Clinic
Information provided by (Responsible Party):
Howard Place, MD, St. Louis University

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. 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.

Condition or disease
Closed Fracture of Shaft of Humerus

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Study Type : Observational
Estimated Enrollment : 164 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Operative Versus Nonoperative Treatment of Humeral Shaft Fractures: A Prospective Cohort Comparison Study
Study Start Date : May 2010
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort
Operative
Operative group would have had surgery to treat their broken humerus.
Nonoperative
Nonoperative group would have been treated with a brace, no surgery.



Primary Outcome Measures :
  1. The primary outcome of this study is the Disability of Arm, Shoulder and Hand (DASH) score. [ Time Frame: Enrollment, 12 Week, 6 Month, and 12 Month Follow-Ups ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged 18 to 65 years with a humeral shaft fracture.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363518


Locations
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United States, Indiana
Indiana University-Wishard Hospital
Indianapolis, Indiana, United States, 49053
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Virginia
Inova Fairfax
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
St. Louis University
Boston Medical Center
Inova Fairfax Hospital
Indiana University
Prisma Health-Midlands
Vanderbilt University
Wake Forest University
University of North Carolina
Lahey Clinic
Investigators
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Principal Investigator: Lisa K Cannada, M.D. St. Louis University
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Responsible Party: Howard Place, MD, Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT01363518    
Other Study ID Numbers: 16589
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results will be shared
Keywords provided by Howard Place, MD, St. Louis University:
humerus
fracture
operative treatment
non-operative treatment
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Closed
Wounds and Injuries