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

Radial Head Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03364595
• Other study ID #: CSGK-RGXT
• Status: Not yet recruiting
• Phase: N/A
• First received: December 1, 2017
• Last updated: December 1, 2017
• Start date: April 1, 2018
• Est. completion date: May 30, 2018

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: Yichong Zhang, MD
• Phone: 15210802766
• Email: 875274428[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Fractures, Bone
• Radial Head Fracture
• Radius Fractures

Intervention

Procedure:
• plate fixation
ORIF of the radial head fracture
• replacement
replacement of the radial head fracture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Union rate	Union rate of the fracture from X-ray	1 year after surgery
Secondary	Functional score	Mayo score of injury elbow	1 year after surgery