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Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure

NCT ID: NCT03364062

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-10

Study Completion Date

2019-12-10

Brief Summary

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To clarify the downward trend of blood pressure affected by bone cement implantation during shoulder replacement operations.

Detailed Description

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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．

Conditions

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Blood Pressure

Keywords

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Blood Pressure shoulder replacement proximal humeral fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cemented shoulder replacement patients

A total of 350 cases of proximal humeral fracture receiving cemented shoulder replacement in Department of Orthopedics and Trauma

cemented shoulder replacement

Intervention Type PROCEDURE

proximal humeral fracture receiving hemi-shoulder replacement with cement when inserting the stem

Interventions

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cemented shoulder replacement

proximal humeral fracture receiving hemi-shoulder replacement with cement when inserting the stem

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pathologic fracture
* severe hypertension or hypotension
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Dalian Medical University

OTHER

Sponsor Role collaborator

Taoyuan General Hospital

OTHER_GOV

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Peixun

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yichong Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

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Yichong Zhang, MD

Role: CONTACT

Phone: 15210802766

Email: [email protected]

Other Identifiers

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GCS-CISR

Identifier Type: -

Identifier Source: org_study_id