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

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

Study Overview

• Status: Unknown
• Conditions: Radial Head Fracture
• Intervention / Treatment: Procedure: plate fixation; Procedure: replacement

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 Type: Observational
• Enrollment (Anticipated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Men or women aged 18 to 65 years of age with Mason Type III radial head fracture

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Plate Fixation; The operating surgeon will determine the positioning of the patient for surgery. ORIF of the radial head fracture will be carried out	Procedure: plate fixation; 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.	Procedure: replacement; replacement of the radial head fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Union rate	Union rate of the fracture from X-ray	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional score	Mayo score of injury elbow	1 year after surgery

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Director: Peixun Zhang, MD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2018
• Primary Completion (ANTICIPATED): May 30, 2018
• Study Completion (ANTICIPATED): May 30, 2018

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (ACTUAL): December 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: replacement; plate; radial head fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: CSGK-RGXT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No