Postieror Malleolar FractureNCT03064386
Comparative Study of Postieror Ankle Fracture
A study testing Plate fixation and Screw fixation in people with Postieror Malleolar Fracture and Treatment, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
Trial summary
To compare the clinical efficacy of open reduction and internal fixation (ORIF) with plate and screw for postieror malleolar fractures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postieror Malleolar Fracture, Treatment
- What is being tested?
- Plate fixation and Screw fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2017to 28 Feb 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- supination-external rotation Ⅳ type injury
Who cannot join
- Pion fracture; Isolated posterior ankle fracture.
Trial locations and contacts
No sites are listed yet.
Yunfeng Yang, Ph.D. contact
About this study
Official title: Comparative Study of Postieror Malleolar Fracture With Plate and Screw Fixation
To compare the clinical efficacy of open reduction and internal fixation (ORIF) with plate and screw for postieror malleolar fractures.
- Conditions
- Postieror Malleolar Fracture, Treatment
- Being tested
- Plate fixation, Screw fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plate fixationProcedure or surgery
internal fixation with the plate
Screw fixationProcedure or surgery
internal fixation with the screw
| Study group | Role | What they receive |
|---|---|---|
| plate group | Experimental | internal fixation with the plate Receives: Procedure: Plate fixation |
| screw group | Experimental | internal fixation with the screw Receives: Procedure: Screw fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional score
AOFAS function score for ankle
Measured: One 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 posted27 Feb 2017
- Study start28 Feb 2017 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postieror Malleolar FractureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liming Cheng, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064386
- Sponsor's protocol ID
- 56014768-6
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Postieror Malleolar Fracture With Plate and Screw Fixation
- ClinicalTrials.gov ID
- NCT03064386
- Acronym / sponsor ID
- 56014768-6
- Conditions
- Postieror Malleolar Fracture, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Study start
- 28 Feb 2017 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 27 Feb 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 clinical efficacy of open reduction and internal fixation (ORIF) with plate and screw for postieror malleolar fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plate group | Experimental | Procedure: Plate fixationinternal fixation with the plate |
| screw group | Experimental | Procedure: Screw fixationinternal fixation with the screw |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- supination-external rotation Ⅳ type injury
Key exclusion criteria (1 listed)
- Pion fracture; Isolated posterior ankle fracture.
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 fixationinternal fixation with the plate | Procedure or surgery | plate group |
| Screw fixationinternal fixation with the screw | Procedure or surgery | screw group |
Primary outcome
functional score
Time frame: One year after surgery
AOFAS function score for ankle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
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.
Yunfeng Yang, Ph.D. contact
Questions about this trial
What is this clinical trial studying?
A study testing Plate fixation and Screw fixation in people with Postieror Malleolar Fracture and Treatment, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
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 27 Feb 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 Yunfeng Yang, Ph.D. (+86 13918588939), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional score (time frame: One 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 27 Feb 2017.