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Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure

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ClinicalTrials.gov Identifier: NCT03364062
Recruitment Status : Unknown
Verified November 2017 by Zhang Peixun, Peking University People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborators:
First Affiliated Hospital of Harbin Medical University
Dalian Medical University
Taoyuan General Hospital
Information provided by (Responsible Party):
Zhang Peixun, Peking University People's Hospital

Study Description
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Brief Summary:
To clarify the downward trend of blood pressure affected by bone cement implantation during shoulder replacement operations.

Condition or disease Intervention/treatment
Blood Pressure Procedure: cemented shoulder replacement

Detailed Description:
A total of 350 cases of proximal humeral fracture are planned to be recruited and receive semi-shoulder replacement in Department of Orthopedics and Trauma，Peking University People's Hospital．The blood pressure data are collected from patients' anesthesia records. Both the systolic and diastolic blood pressure are recorded at four time spots during operation: the time before using of bone cement (time period A), 0-5 min after using cement (time period B), 5-10 min after using cement (time period C) and 10-15min after using cement (time period D). The data of blood pressure are collected according to anesthesia records．
Study Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center Study on Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure
Estimated Study Start Date : February 10, 2018
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : December 10, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
cemented shoulder replacement patients
A total of 350 cases of proximal humeral fracture receiving cemented shoulder replacement in Department of Orthopedics and Trauma
 Procedure: cemented shoulder replacement
proximal humeral fracture receiving hemi-shoulder replacement with cement when inserting the stem


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Systolic Blood Pressure [ Time Frame: Change from Baseline Systolic Blood Pressure at 15 mins ]
    the systolic blood pressure after insert the cemented stem


Secondary Outcome Measures :
  1. Change from Baseline Diastolic Blood Pressure [ Time Frame: Change from Baseline Diastolic Blood Pressure at 15 mins ]
    the diastolic blood pressure after insert the cemented stem


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients with three or four part of proximal humeral fracture, receive shoulder replacement
Criteria

Inclusion Criteria:

•patients with three or four part of proximal humeral fracture receiving cemented shoulder replacement

Exclusion Criteria:

  • pathologic fracture
  • severe hypertension or hypotension
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364062


Contacts
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Contact: Yichong Zhang, MD 15210802766 875274428@qq.com

Sponsors and Collaborators
Peking University People's Hospital
First Affiliated Hospital of Harbin Medical University
Dalian Medical University
Taoyuan General Hospital
Investigators
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Principal Investigator: Yichong Zhang, MD Peking University People's Hospital
More Information
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Responsible Party: Zhang Peixun, Clinical Professor, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03364062    
Other Study ID Numbers: GCS-CISR
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhang Peixun, Peking University People's Hospital:
Blood Pressure
shoulder replacement
proximal humeral fracture