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

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



Sponsors


Source

Peking University People's Hospital

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2018-04-01

Completion Date

2018-05-30

Primary Completion Date

2018-05-30

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Union rate
1 year after surgery

Secondary Outcome

Measure

Time Frame

Functional score
1 year after surgery

Number Of Groups

2

Enrollment

60

Condition


Intervention

Intervention Type

Procedure

Intervention Name


Description

ORIF of the radial head fracture

Arm Group Label

Plate Fixation


Intervention Type

Procedure

Intervention Name


Description

replacement of the radial head fracture

Arm Group Label

Replacement



Eligibility

Study Pop

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

Sampling Method

Non-Probability Sample

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.)

Gender

All

Minimum Age

18 Years

Maximum Age

65 Years


Overall Official

Last Name

Role

Affiliation

Peixun Zhang, MD
Study Director
Peking University People's Hospital

Overall Contact

Last Name

Yichong Zhang, MD

Phone

15210802766

Email



Verification Date

2017-12-01

Lastchanged Date

2017-12-01

Firstreceived Date

2017-12-01

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Peking University People's Hospital

Investigator Full Name

Zhang Yichong

Investigator Title

Department of orthopaedics and trauma


Keywords


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Plate Fixation

Description

The operating surgeon will determine the positioning of the patient for surgery. ORIF of the radial head fracture will be carried out


Arm Group Label

Replacement

Description

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.



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Retrospective


Study First Submitted

December 1, 2017

Study First Submitted Qc

December 1, 2017

Study First Posted

December 6, 2017

Last Update Submitted

December 1, 2017

Last Update Submitted Qc

December 1, 2017

Last Update Posted

December 6, 2017


ClinicalTrials.gov processed this data on December 06, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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