Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure

A Multi-center Study on Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure

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

Study Overview

• Status: Unknown
• Conditions: Blood Pressure
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 350

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with three or four part of proximal humeral fracture, receive shoulder replacement

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pathologic fracture
• severe hypertension or hypotension

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Systolic Blood Pressure	the systolic blood pressure after insert the cemented stem	Change from Baseline Systolic Blood Pressure at 15 mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Diastolic Blood Pressure	the diastolic blood pressure after insert the cemented stem	Change from Baseline Diastolic Blood Pressure at 15 mins

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: First Affiliated Hospital of Harbin Medical University; Taoyuan General Hospital; Dalian Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 10, 2018
• Primary Completion (Anticipated): December 10, 2019
• Study Completion (Anticipated): December 10, 2019

Study Registration Dates

• First Submitted: November 26, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Blood Pressure; shoulder replacement; proximal humeral fracture
• Other Study ID Numbers: GCS-CISR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No