NCT03925688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2019

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

19 days

First QC Date

April 21, 2019

Last Update Submit

April 23, 2019

Conditions

Keywords

heterotopic ossificationserum uric acid,elbow joint

Outcome Measures

Primary Outcomes (1)

  • serum uric acid value

    The serum uric acid was measured by standard equipment in the laboratory

    the outcome of serum uric acid can acquire within half a day.

Study Arms (2)

without heterotopic ossification

There had not existed radiographic evidences of heterotopic ossification.

with heterotopic ossification

There had existed radiographic evidences of heterotopic ossification or formatted ectopic lamellar bone.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population came from The Second Affiliated Hospital of Zhejiang University.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Ossification, Heterotopic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jian'an Wang, Ph.D

    Zhejiang University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2019

First Posted

April 24, 2019

Study Start

March 13, 2019

Primary Completion

April 1, 2019

Study Completion

April 10, 2019

Last Updated

April 25, 2019

Record last verified: 2019-04

Locations