Avascular Necrosis of HipNCT02951741
Revision Total Hip Replacement Arthroplasty and Hematologic Variables
An observational study of Avascular Necrosis of Hip and Degenerative Hip Joint Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Revision total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Avascular Necrosis of Hip, Degenerative Hip Joint Disease
- What is being tested?
- RTHRA group
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Feb 2017
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing revision total hip replacement
Who may be able to join
- revision total hip replacement
Who cannot join
- hematologic disease
- anticoagulant medication
- American Society of Anesthesiologists physical status 4 and 5
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Relations Between Hematologic Variables and Postoperative Bleeding and Transfusion in Revision Total Hip Replacement Arthroplasty
Revision total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.
- Being tested
- RTHRA group
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTHRA groupOther
hematologic variables measurement in patients undergoing revision total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| RTHRA group | patients undergoing revision total hip replacement Receives: Other: RTHRA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of FIBTEM
FIBTEM: one of the measurements of the rotational thromboelastometry
Measured: 5 minutes before initiation of anesthesia and 5 minutes after finishing operation
Secondary outcomes (16)
volume of infused fluid during operation
Infused total crystalloid and colloid volume during the operation will be recorded
Measured: Period from starting to finishing the operation (During operation, an expected average of 3 hours)
intraoperative urine output
Measured: Period from starting to finishing the operation (During operation, an expected average of 3 hours)
transfusion units
Red blood cell
Measured: Period from starting to finishing the operation (During operation, an expected average of 3 hours) and postoperative first day
postoperative bleeding volume
Measured: postoperative 72 hours
Hemoglobin
Measured: preoperative day 1
Hemoglobin
Measured: postoperative day 4
Hematocrit
Measured: preoperative day 1
Hematocrit
Measured: postoperative day 4
Platelet count
Measured: preoperative day 1
Platelet count
Measured: postoperative day 4
prothrombin time_international normalized ratio
Measured: preoperative day 1
prothrombin time_international normalized ratio
Measured: postoperative day 1
activated partial prothrombin time
Measured: preoperative day 1
activated partial prothrombin time
Measured: postoperative day 1
fibrinogen concentration
Measured: preoperative day 1
fibrinogen concentration
Measured: postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startApr 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular Necrosis of HipStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
- Investigators
- Hyo-Seok Na, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951741
- Sponsor's protocol ID
- B-1502/288-302
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relations Between Hematologic Variables and Postoperative Bleeding and Transfusion in Revision Total Hip Replacement Arthroplasty
- ClinicalTrials.gov ID
- NCT02951741
- Acronym / sponsor ID
- B-1502/288-302
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- 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.
Revision total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RTHRA group | – | Other: RTHRA grouppatients undergoing revision total hip replacement |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing revision total hip replacement
Key inclusion criteria (1 listed)
- revision total hip replacement
Key exclusion criteria (3 listed)
- hematologic disease
- anticoagulant medication
- American Society of Anesthesiologists physical status 4 and 5
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 |
|---|---|---|
| RTHRA grouphematologic variables measurement in patients undergoing revision total hip replacement | Other | RTHRA group |
Primary outcome
Change of FIBTEM
Time frame: 5 minutes before initiation of anesthesia and 5 minutes after finishing operation
FIBTEM: one of the measurements of the rotational thromboelastometry
16 secondary outcomes
volume of infused fluid during operation
Time frame: Period from starting to finishing the operation (During operation, an expected average of 3 hours)
intraoperative urine output
Time frame: Period from starting to finishing the operation (During operation, an expected average of 3 hours)
transfusion units
Time frame: Period from starting to finishing the operation (During operation, an expected average of 3 hours) and postoperative first day
postoperative bleeding volume
Time frame: postoperative 72 hours
Hemoglobin
Time frame: preoperative day 1
Hemoglobin
Time frame: postoperative day 4
Hematocrit
Time frame: preoperative day 1
Hematocrit
Time frame: postoperative day 4
Platelet count
Time frame: preoperative day 1
Platelet count
Time frame: postoperative day 4
prothrombin time_international normalized ratio
Time frame: preoperative day 1
prothrombin time_international normalized ratio
Time frame: postoperative day 1
activated partial prothrombin time
Time frame: preoperative day 1
activated partial prothrombin time
Time frame: postoperative day 1
fibrinogen concentration
Time frame: preoperative day 1
fibrinogen concentration
Time frame: postoperative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Individual participant dataSharing planned: No
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The Medacta International SMS Post-Marketing Surveillance Study
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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.
Hyo-Seok Na, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Avascular Necrosis of Hip and Degenerative Hip Joint Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of FIBTEM (time frame: 5 minutes before initiation of anesthesia and 5 minutes after finishing operation). 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 11 Oct 2017.