Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03364062
• Other study ID #: GCS-CISR
• Status: Not yet recruiting
• Phase: N/A
• First received: November 26, 2017
• Last updated: December 4, 2017
• Start date: February 10, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: Yichong Zhang, MD
• Phone: 15210802766
• Email: 875274428[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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．

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pathologic fracture

• severe hypertension or hypotension

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Procedure:
• cemented shoulder replacement
proximal humeral fracture receiving hemi-shoulder replacement with cement when inserting the stem

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Peking University People's Hospital	Dalian Medical University, First Affiliated Hospital of Harbin Medical University, Taoyuan General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline Diastolic Blood Pressure	the diastolic blood pressure after insert the cemented stem	Change from Baseline Diastolic Blood Pressure at 15 mins