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
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.
- 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.
- 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.
- Complication rates of infection and iatrogenic neurologic injury will be higher in patients treated operatively.
- Nonunion and malunion will be higher in patients managed conservatively.
|Condition or disease|
|Closed Fracture of Shaft of Humerus|
|Study Type :||Observational|
|Estimated Enrollment :||164 participants|
|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|
Operative group would have had surgery to treat their broken humerus.
Nonoperative group would have been treated with a brace, no surgery.
- 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.
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
|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|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Lisa K Cannada, M.D.||St. Louis University|