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

• Conditions: Radial Head Fracture
• Interventions: Procedure: plate fixation; Procedure: replacement

• Registration Number: NCT03364595
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-01
• Last Update Submitted: 2017-12-01
• Study First Posted: 2017-12-06
• Last Update Posted: 2017-12-06
• Study Start: 2018-04-01
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Union rate	1 year after surgery	Union rate of the fracture from X-ray

Secondary Outcome Measures

Name	Time	Method
Functional score	1 year after surgery	Mayo score of injury elbow