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

P

Peking University

Status

Unknown

Conditions

Radial Head Fracture

Treatments

Procedure: plate fixation
Procedure: replacement

Study type

Observational

Funder types

Other

Identifiers

NCT03364595
CSGK-RGXT

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.)

Trial design

60 participants in 2 patient groups

Plate Fixation
Description:
The operating surgeon will determine the positioning of the patient for surgery. ORIF of the radial head fracture will be carried out
Treatment:
Procedure: plate fixation
Replacement
Description:
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.
Treatment:
Procedure: replacement

Trial contacts and locations

0

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Central trial contact

Yichong Zhang, MD

Data sourced from clinicaltrials.gov

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