Knee Arthroplasty, TotalNCT04575246
Predictors and Outcomes of Intraoperative Hypothermia in Patients Undergoing Knee Arthroplasty
An observational study of Knee Arthroplasty, Total and Hypothermia, run by Aga Khan University.
Trial summary
The study is designed to retrospectively assess the risk factors associated with intra-operative hypothermia in patients undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University and also understand it's impact on post-operative outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total, Hypothermia
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All adults greater than 18 years undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University were included in this study. A standardized proforma was used to collect data from online patient data system about patients' preoperative, intraoperative and postoperative details. Preoperative data included age, gender, and comorbid conditions. Intraoperative data was collected from the surgical and anaesthesia records and included surgical site, American Society of Anesthesiologists (ASA) Level, duration of surgery, preoperative body temperature, intraoperative body temperature and duration of surgery. Postoperative data included post-operative body temperature and whether the patient developed any surgical site infection.
Who may be able to join
- All adults greater than 18 years who underwent total knee arthroplasty.
Who cannot join
- Any patient below 18 years
About this study
Official title: Predictors and Outcomes of Intraoperative Hypothermia in Patients Undergoing Total Knee Arthroplasty: A Retrospective Cross-sectional Study From a Developing Country
The study is designed to retrospectively assess the risk factors associated with intra-operative hypothermia in patients undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University and also understand it's impact on post-operative outcomes.
- Conditions
- Knee Arthroplasty, Total, Hypothermia
- Medical subject headings
- Hypothermia
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (SSI)
Post-operative infection caused total knee arthroplasty
Measured: 2016-2017
Post-operative hypothermia
Body temperature after surgery when patient is in the recovery room.
Measured: Within an hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Arthroplasty, TotalStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anum Sadruddin, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575246
- Sponsor's protocol ID
- 2019-1274-3270
- Status last verified
- Oct 2020
- First submitted
- 29 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ukrani RD, Arif A, Sadruddin A, Hasan O, Noordin S. Intraoperative hypothermia in patients undergoing Total knee arthroplasty: a cross-sectional study from a developing country. BMC Musculoskelet Disord. 2021 May 31;22(1):504. doi: 10.1186/s12891-021-04390-7.
PubMed 34059046
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Outcomes of Intraoperative Hypothermia in Patients Undergoing Total Knee Arthroplasty: A Retrospective Cross-sectional Study From a Developing Country
- ClinicalTrials.gov ID
- NCT04575246
- Acronym / sponsor ID
- 2019-1274-3270
- Conditions
- Knee Arthroplasty, Total, Hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 Oct 2020 (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.
The study is designed to retrospectively assess the risk factors associated with intra-operative hypothermia in patients undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University and also understand it's impact on post-operative outcomes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adults greater than 18 years undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University were included in this study. A standardized proforma was used to collect data from online patient data system about patients' preoperative, intraoperative and postoperative details. Preoperative data included age, gender, and comorbid conditions. Intraoperative data was collected from the surgical and anaesthesia records and included surgical site, American Society of Anesthesiologists (ASA) Level, duration of surgery, preoperative body temperature, intraoperative body temperature and duration of surgery. Postoperative data included post-operative body temperature and whether the patient developed any surgical site infection.
Key inclusion criteria (1 listed)
- All adults greater than 18 years who underwent total knee arthroplasty.
Key exclusion criteria (1 listed)
- Any patient below 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical Site Infection (SSI)
Time frame: 2016-2017
Post-operative infection caused total knee arthroplasty
Post-operative hypothermia
Time frame: Within an hour after surgery
Body temperature after surgery when patient is in the recovery room.
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 8 Oct 2020.
- Derived from this study: PubMed 34059046Ukrani RD, Arif A, Sadruddin A, Hasan O, Noordin S. Intraoperative hypothermia in patients undergoing Total knee arthroplasty: a cross-sectional study from a developing country. BMC Musculoskelet Disord. 2021 May 31;22(1):504. doi: 10.1186/s12891-021-04390-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty, Total and Hypothermia, run by Aga Khan University.
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 1 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 8 Oct 2020. 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?
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?
Surgical Site Infection (SSI) (time frame: 2016-2017). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575246, which also lists 1 linked publication.
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 8 Oct 2020.