Blood PressureNCT03364062
Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure
An observational study of Blood Pressure, run by Peking University People's Hospital.
Trial summary
To clarify the downward trend of blood pressure affected by bone cement implantation during shoulder replacement operations. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- cemented shoulder replacement
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2018to 10 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: patients with three or four part of proximal humeral fracture, receive shoulder replacement
Who may be able to join
- •patients with three or four part of proximal humeral fracture receiving cemented shoulder replacement
Who cannot join
- pathologic fracture
- severe hypertension or hypotension
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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．
- Conditions
- Blood Pressure
- Being tested
- cemented shoulder replacement
- Keywords
- Blood Pressure, shoulder replacement, proximal humeral fracture
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cemented shoulder replacementProcedure or surgery
proximal humeral fracture receiving hemi-shoulder replacement with cement when inserting the stem
| Study group | Role | What they receive |
|---|---|---|
| cemented shoulder replacement patients | A total of 350 cases of proximal humeral fracture receiving cemented shoulder replacement in Department of Orthopedics and Trauma Receives: Procedure: cemented shoulder replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Systolic Blood Pressure
the systolic blood pressure after insert the cemented stem
Measured: Change from Baseline Systolic Blood Pressure at 15 mins
Secondary outcomes (1)
Change from Baseline Diastolic Blood Pressure
the diastolic blood pressure after insert the cemented stem
Measured: Change from Baseline Diastolic Blood Pressure at 15 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start10 Feb 2018 (estimated)
- Primary completion10 Dec 2019 (estimated)
- Study completion10 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, Dalian Medical University, Taoyuan General Hospital
- Responsible party
- Principal investigator, Zhang Peixun, Peking University People's Hospital
- Investigators
- Yichong Zhang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364062
- Sponsor's protocol ID
- GCS-CISR
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study on Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure
- ClinicalTrials.gov ID
- NCT03364062
- Acronym / sponsor ID
- GCS-CISR
- Conditions
- Blood Pressure
- Keywords
- Blood Pressure, shoulder replacement, proximal humeral fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, Dalian Medical University, Taoyuan General Hospital
- Study start
- 10 Feb 2018 (estimated)
- Primary completion
- 10 Dec 2019 (estimated)
- Study completion
- 10 Dec 2019 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To clarify the downward trend of blood pressure affected by bone cement implantation during shoulder replacement operations.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cemented shoulder replacement patients | – | Procedure: cemented shoulder replacementA total of 350 cases of proximal humeral fracture receiving cemented shoulder replacement in Department of Orthopedics and Trauma |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with three or four part of proximal humeral fracture, receive shoulder replacement
Key inclusion criteria (1 listed)
- •patients with three or four part of proximal humeral fracture receiving cemented shoulder replacement
Key exclusion criteria (2 listed)
- pathologic fracture
- severe hypertension or hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cemented shoulder replacementproximal humeral fracture receiving hemi-shoulder replacement with cement when inserting the stem | Procedure or surgery | cemented shoulder replacement patients |
Primary outcome
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
1 secondary outcome
Change from Baseline Diastolic Blood Pressure
Time frame: Change from Baseline Diastolic Blood Pressure at 15 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yichong Zhang, MD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yichong Zhang, MD (15210802766, 875274428@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Systolic Blood Pressure (time frame: Change from Baseline Systolic Blood Pressure at 15 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.