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Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft

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: NCT03358173
Recruitment Status : Unknown
Verified November 2017 by pengzhang, Peking University People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
pengzhang, Peking University People's Hospital

Study Description
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Brief Summary:
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

Condition or disease Intervention/treatment
Humeral Fractures Procedure: Conservative Treatment Procedure: Operative Plate Fixation

Detailed Description:
From Jane 2015 to October 2016, patients with displaced humeral shaft fractures are retrospectively included in this study, they were treated with either operative plate or conservative treatment. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(DASH score) between the 2 groups at 1 year after surgery.
Study Design
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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft
Estimated Study Start Date : December 25, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Conservative Treatment
Standard protocol for conservative treatment will consist of the implementation of a sling and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon.
 Procedure: Conservative Treatment
Conservative Treatment
Operative Plate Fixation
The operating surgeon will determine the positioning of the patient for surgery. ORIF of the humeral shaft fracture will be carried out
 Procedure: Operative Plate Fixation
Operative Plate Fixation


Outcome Measures
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Primary Outcome Measures :
  1. Union rate [ Time Frame: 1 year after surgery ]
    Union rate of the fracture from X-ray


Secondary Outcome Measures :
  1. Functional score [ Time Frame: 1 year after surgery ]
    DASH score of the injured arm


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Men or women aged 18 to 65 years of age Completely displaced ,closed fracture of humeral shaft confirmed by radiograph Fractures within 1 month post injury
Criteria

Inclusion Criteria:

Men or women aged 18 to 65 years of age Completely displaced ,closed fracture of humeral shaft confirmed by radiograph Fractures within 1 month post injury Provision of informed consent

Exclusion Criteria:

Pathological fractures Non-displaced (cortical contact) fractures Open fractures Presence of vascular or nerve injury Fractures more than 1 month post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Contacts and Locations
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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): NCT03358173


Contacts
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Contact: yichong zhang, MD 15210802766 875274428@qq.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Peng Zhang, MD Peking University People's Hospital
More Information
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Responsible Party: pengzhang, Department of orthopaedics and trauma, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03358173    
Other Study ID Numbers: csg-ggggz
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by pengzhang, Peking University People's Hospital:
Humeral Fractures
plate
Conservative Treatment
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries