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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02418260 |
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Date of registration:
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08/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Surgical Interventions for the Treatment of Humeral Shaft Fractures
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Scientific title:
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Surgical Interventions for the Treatment of Humeral Shaft Fractures: Randomized Controlled Clinical Trial |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02418260 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Rafael Pierami |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Sao Paulo |
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Name:
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Rafael Pierami, M.D. |
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Address:
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Telephone:
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+5511982325308 |
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Email:
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rafael_pierami@hotmail.com |
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Affiliation:
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Name:
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Rafael Pierami, M.D. |
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Address:
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Telephone:
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+5511982325308 |
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Email:
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rafael_pierami@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Complete fracture with angulation greater than 20 degrees, rotation greater than 30
degrees and/or shortening greater than 3 cm.
- Fractures located from 4 cm distal to the surgical neck to 2 cm proximal to the end of
the medullary canal.
Exclusion Criteria:
- fractures older than 3 weeks
- pathologic fractures
- fractures with extension to elbow or shoulder joint
- patients with ipsilateral upper extremity fracture or injury
- fractures with associated neurologic injury
- patients with previous pathology of the shoulder, arm or elbow that cause pain or
range of motion limitation
- patients who do not agree with the terms of the study
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fracture of Shaft of Humerus
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Humerus Fracture
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Intervention(s)
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Procedure: Open reduction and plate osteosynthesis
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Procedure: Bridge Plate osteosynthesis
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Procedure: Locked intramedullary nail osteosynthesis
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Primary Outcome(s)
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Changes in the Disabilities of the Arm, Shoulder and Hand (DASH)
[Time Frame: 48 weeks]
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Secondary Outcome(s)
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Time to previous activities return
[Time Frame: 48 weeks]
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Changes in the Visual Analog Scale for Pain (VAS)
[Time Frame: 48 weeks]
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Failure (need for aditional surgical procedure)
[Time Frame: 48 weeks]
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Changes in the Constant-Murley Shoulder Outcome Score
[Time Frame: 48 weeks]
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Radiographic angular deformity
[Time Frame: at 48 weeks]
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Complications (nonunion, symptomatic malunion, hardware related issues, shoulder pain, infection, neurological injury and loss of range of motion of shoulder and/or elbow)
[Time Frame: 48 weeks]
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Secondary ID(s)
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24997313.8.0000.5505
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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