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Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head

NCT ID: NCT03364595

Last Updated: 2017-12-06

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-05-30

Brief Summary

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To compare the effect of Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head

Detailed Description

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From April 2015 to October 2016, patients with comminuted radial head fractures diagnosed as Mason type III are retrospectively included in this study, they were treated with either operative plate or radial head replacement. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(Mayo score) between the 2 groups at 1 year after surgery.

Conditions

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Radial Head Fracture

Keywords

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radial head fracture replacement plate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Plate Fixation

The operating surgeon will determine the positioning of the patient for surgery. ORIF of the radial head fracture will be carried out

plate fixation

Intervention Type PROCEDURE

ORIF of the radial head fracture

Replacement

The operating surgeon will determine the positioning of the patient for surgery. During the surgery, they take out the the comminuted radial head and proceed replacement using artificial.

replacement

Intervention Type PROCEDURE

replacement of the radial head fracture

Interventions

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plate fixation

ORIF of the radial head fracture

Intervention Type PROCEDURE

replacement

replacement of the radial head fracture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Men or women aged 18 to 65 years of age with Mason Type III radial head fracture are confirmed by radiograph 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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Zhang Yichong

Department of orthopaedics and trauma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peixun Zhang, MD

Role: STUDY_DIRECTOR

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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CSGK-RGXT

Identifier Type: -

Identifier Source: org_study_id