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Clinical Trials/NCT03364595
NCT03364595
Unknown
Not Applicable

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

Peking University People's Hospital0 sites60 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radial Head Fracture
Sponsor
Peking University People's Hospital
Enrollment
60
Primary Endpoint
Union rate
Last Updated
8 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
May 30, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhang Yichong

Department of orthopaedics and trauma

Peking University People's Hospital

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

Union rate

Time Frame: 1 year after surgery

Union rate of the fracture from X-ray

Secondary Outcomes

  • Functional score(1 year after surgery)

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