NCT03364062

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Status
unknown

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

First Submitted

Initial submission to the registry

November 26, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 10, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

December 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

November 26, 2017

Last Update Submit

December 4, 2017

Conditions

Blood Pressure

Keywords

Blood Pressureshoulder replacementproximal humeral fracture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from Baseline Diastolic Blood Pressure

    Change from Baseline Diastolic Blood Pressure at 15 mins

Study Arms (1)

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

Interventions

cemented shoulder replacementPROCEDURE

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

cemented shoulder replacement patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • pathologic fracture
  • severe hypertension or hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Officials

  • Yichong Zhang, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yichong Zhang, MD

CONTACT

15210802766875274428@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 26, 2017

First Posted

December 6, 2017

Study Start

February 10, 2018

Primary Completion

December 10, 2019

Study Completion

December 10, 2019

Last Updated

December 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share