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NCT01363518 · ClinicalTrials.gov registry record
Operative Versus Nonoperative Treatment of Humeral Shaft Fractures: A Prospective Cohort Comparison Study
A clinical trial, sponsored by St. Louis University.
- Completed
- Registry status
- 164
- Enrollment target
NCT01363518: Completed study, sponsored by St. Louis University.
NCT01363518 is a clinical trial that has completed, run by St. Louis University. The registered enrollment target is 164 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01363518 has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- 164 participants
- Enrollment target
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 pat
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2010-05 |
| Est. Completion | 2018-11-20 |
What the finished NCT01363518 record still lists
NCT01363518 is an observational study that tracks outcomes without assigning an intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01363518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01363518 about?
NCT01363518 is a clinical study titled "Operative Versus Nonoperative Treatment of Humeral Shaft Fractures: A Prospective Cohort Comparison Study". 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 tre...
What is the current status of trial NCT01363518?
This trial is currently completed. The enrollment target is 164 participants. The study started on 2010-05. Estimated completion is 2018-11-20.
Who is sponsoring clinical trial NCT01363518?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
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