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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Assessment of Heterotopic Ossification of Elbow Joint in Relation of Serum Uric Acid.

Clinicaltrials.gov identifier NCT03925688

Recruitment Status Completed

First Posted April 24, 2019

Last update posted April 25, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Heterotopic Ossification
  • Intervention/Treatment:
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 100 participants
  • Observational Model: Case-Control
  • Time Perspective: Retrospective
  • Official Title: Assessment of Heterotopic Ossification of Elbow Joint in Relation of Serum Uric Acid: a Retrospective Study.
  • Actual Study Start Date: March 2019
  • Actual Primary Completion Date: April 2019
  • Actual Study Completion Date: April 2019
Outcome Measures
  • Primary Outcome Measures: 1. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Probability Sample
  • Study Population: The population came from The Second Affiliated Hospital of Zhejiang University.
Criteria

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.

Contacts and Locations
Contacts
Locations

China, Zhejiang
Institutional Review Board of The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Chair: Jian'an Wang, Ph.D Zhejiang University

More Information
  • Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
  • ClinicalTrials.gov Identifier: NCT03925688 History of Changes
  • Other Study ID Numbers: I2019001071
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 25, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University: heterotopic ossification
    serum uric acid,
    elbow joint
  • Additional relevant MeSH terms: Ossification, Heterotopic