- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925688
Assessment of Heterotopic Ossification of Elbow Joint in Relation of Serum Uric Acid.
April 23, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Assessment of Heterotopic Ossification of Elbow Joint in Relation of Serum Uric Acid: a Retrospective Study.
Heterotopic ossification (HO) is a common complication after surgical repair of elbow trauma.
Uric acid is the end-product of purine metabolism that has any physiological and pathogenic potential functions.
However, the relationship of HO and uric acid has not been explored up to now.
This study aimed to assess the relationship of HO and uric acid.
The investigators retrospectively reviewed the demographics of participants who undergone the surgery for elbow trauma in our hospital between January 2012 and December 2018.
One hundred participants included in our study.
The participants were divided into two groups by the existing HO or not.
The serum uric acid between both groups were compared by using the independent samples student T tests.
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators retrospectively analyzed the demographics of these participants in our hospital who underwent the surgery after trauma of elbow joint between January 2012 and December 2018.
All of the participants had a previous history of elbow joint fractures including distal humerus fracture or proximal ulna fracture or capitulum radii fracture or elbow fracture dislocation.
According to X ray or CT scan, the participants were divided into two groups.
One group the participants had not existed radiographic evidence of heterotopic ossification or formatted ectopic lamellar bone.
And the other group is the participants with radiographic evidence of heterotopic ossification.
And we recorded patient serum uric acid, sex and age, Body Mass Index (BMI), the situation of joint trauma and comorbid conditions including diabetes mellitus or impaired blood glucose, gout, metabolic syndrome, osteoporosis and various vitamin deficiency diseases.
Moreover, the grades of heterotopic ossification were recorded for all patients according to Hastings and Graham Classification System for Heterotopic Ossification at the Elbow Joint.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China
- Institutional Review Board of The Second Affiliated Hospital of Zhejiang University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The population came from The Second Affiliated Hospital of Zhejiang University.
Description
Inclusion Criteria:
- Have a previous history of elbow joint fracture or dislocation that conform to its manifestations and signs. And it is diagnosed by X-ray test. HO must accord with the relative diagnostic criteria5 and have imaging evidences of heterotopic ossification.
- Have complete clinical and imaging dates.
- The age>18 and no gender limitation.
- The patient is being a relatively stable physical and mental state without acute injection or diseases.
Exclusion Criteria:
- Have a history of diabetes mellitus or impaired blood glucose, metabolic syndrome and gout or renal dysfunction (creatinine ≥ 1.5 mg/dL) that apparently influence glucose, lipid and protein metabolic of the body.
- Have a history of taking drugs that can influence uric acid metabolic including gout suppressant, diuretic, small-dose aspirin (75~300mg/d) or large-dose aspirin (>3g/d), anti-tuberculosis drugs, immunosuppressor, nicotinic acid and anti-tumor drugs such as cyclophosphamide and so on.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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without heterotopic ossification
There had not existed radiographic evidences of heterotopic ossification.
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with heterotopic ossification
There had existed radiographic evidences of heterotopic ossification or formatted ectopic lamellar bone.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum uric acid value
Time Frame: the outcome of serum uric acid can acquire within half a day.
|
The serum uric acid was measured by standard equipment in the laboratory
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the outcome of serum uric acid can acquire within half a day.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jian'an Wang, Ph.D, Zhejiang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2019
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
April 10, 2019
Study Registration Dates
First Submitted
April 21, 2019
First Submitted That Met QC Criteria
April 21, 2019
First Posted (Actual)
April 24, 2019
Study Record Updates
Last Update Posted (Actual)
April 25, 2019
Last Update Submitted That Met QC Criteria
April 23, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I2019001071
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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