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

NCT ID: NCT03358173

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-25

Study Completion Date

2018-06-01

Brief Summary

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Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

Detailed Description

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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.

Conditions

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Humeral Fractures

Keywords

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Humeral Fractures plate Conservative Treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Conservative Treatment

Intervention Type PROCEDURE

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

Operative Plate Fixation

Intervention Type PROCEDURE

Operative Plate Fixation

Interventions

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Conservative Treatment

Conservative Treatment

Intervention Type PROCEDURE

Operative Plate Fixation

Operative Plate Fixation

Intervention Type PROCEDURE

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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pengzhang

Department of orthopaedics and trauma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peng Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

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yichong zhang, MD

Role: CONTACT

Phone: 15210802766

Email: [email protected]

Other Identifiers

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csg-ggggz

Identifier Type: -

Identifier Source: org_study_id