Radial Head FractureNCT03364595
Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head
An observational study of Radial Head Fracture, run by Peking University People's Hospital.
Trial summary
To compare the effect of Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radial Head Fracture
- What is being tested?
- plate fixation and replacement
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 30 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Men or women aged 18 to 65 years of age with Mason Type III radial head fracture
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
No sites are listed yet.
About this study
To compare the effect of Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head
Read the 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.
- Conditions
- Radial Head Fracture
- Being tested
- plate fixation, replacement
- Keywords
- radial head fracture, replacement, plate
- Medical subject headings
- Radial Head and Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plate fixationProcedure or surgery
ORIF of the radial head fracture
replacementProcedure or surgery
replacement of the radial head fracture
| Study group | Role | What they receive |
|---|---|---|
| Plate Fixation | The operating surgeon will determine the positioning of the patient for surgery. ORIF of the radial head fracture will be carried out Receives: Procedure: plate fixation | |
| 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. Receives: Procedure: replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union rate
Union rate of the fracture from X-ray
Measured: 1 year after surgery
Secondary outcomes (1)
Functional score
Mayo score of injury elbow
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Apr 2018 (estimated)
- Primary completion30 May 2018 (estimated)
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Head FractureStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Yichong, Peking University People's Hospital
- Investigators
- Peixun Zhang, MD, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364595
- Sponsor's protocol ID
- CSGK-RGXT
- Status last verified
- Dec 2017
- First submitted
- 1 Dec 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head
- ClinicalTrials.gov ID
- NCT03364595
- Acronym / sponsor ID
- CSGK-RGXT
- Conditions
- Radial Head Fracture
- Keywords
- radial head fracture, replacement, plate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plate Fixation | – | Procedure: plate fixationThe operating surgeon will determine the positioning of the patient for surgery. ORIF of the radial head fracture will be carried out |
| Replacement | – | Procedure: replacementThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Men or women aged 18 to 65 years of age with Mason Type III radial head fracture
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plate fixationORIF of the radial head fracture | Procedure or surgery | Plate Fixation |
| replacementreplacement of the radial head fracture | Procedure or surgery | Replacement |
Primary outcome
Union rate
Time frame: 1 year after surgery
Union rate of the fracture from X-ray
1 secondary outcome
Functional score
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Radial Head Fracture
Active, not recruiting
RHEVOLUTION Clinical Trial: Use of Two Radial Head Arthroplasty Designs for the Treatment of Elbow Instability
Elbow Arthropathy, Elbow Dislocation
Recruiting
The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures
Elbow Pain, Supracondylar Humerus Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peixun Zhang, MD study director
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Head Fracture, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yichong Zhang, MD (15210802766, 875274428@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Union rate (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.