Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head
1 other identifier
observational
60
0 countries
N/A
Brief Summary
To compare the effect of Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2018
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2017
CompletedFirst Posted
Study publicly available on registry
December 6, 2017
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2018
CompletedDecember 6, 2017
December 1, 2017
2 months
December 1, 2017
December 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Union rate
Union rate of the fracture from X-ray
1 year after surgery
Secondary Outcomes (1)
Functional score
1 year after surgery
Study Arms (2)
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
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.
Interventions
Eligibility Criteria
Men or women aged 18 to 65 years of age with Mason Type III radial head fracture
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peixun Zhang, MD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of orthopaedics and trauma
Study Record Dates
First Submitted
December 1, 2017
First Posted
December 6, 2017
Study Start
April 1, 2018
Primary Completion
May 30, 2018
Study Completion
May 30, 2018
Last Updated
December 6, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share