Hip FracturesNCT02692989
The Safety of Anesthesia Management for Traumatic Hip Surgery in Elderly
An observational study of Hip Fractures, run by University of Jordan at 1 site in Jordan.
Trial summary
Trauma for hip joint is common in old people. Anesthesia in these types of old patients carries more risk than the adult population. In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia, and to see if type of anesthesia affects patient's outcome and the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Hip fracture surgery and anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 1,270 participants
- Where
- 1 siteJordan
- Study dates
- Jan 2016to Sep 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who sustained hip fracture and underwent surgical correction under Regional or general anesthesia and had intraoperative or postoperative complications
Who may be able to join
- patients who sustained hip fracture.
- patients who underwent surgical correction under Regional or general anesthesia.
Who cannot join
- Patients who sustained Hip fractures but treated conservatively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety of Anesthesia Management for Traumatic Hip Surgery in Elderly: A Retrospective Study in a Tertiary Hospital
Trauma for hip joint is common in old people. Anesthesia in these types of old patients carries more risk than the adult population.
In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications.
Read the detailed description
Trauma for hip joint is common in old people; usually trauma for the hip joint is treated surgically under anesthesia. Anesthesia in these types of old patients carries more risk than the adult population, since these type of patients have a lot of chronic diseases which affect their general health.
In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia between the years 2010 to 2015, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications like Deep Venous Thrombosis, Pulmonary complications, myocardial Infarction and others.
- Conditions
- Hip Fractures
- Being tested
- Hip fracture surgery and anesthesia
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip fracture surgery and anesthesiaProcedure or surgery
any operative fixation for hip fracture whether under General Anesthesia or Regional anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who sustained hip fracture and underwent surgical correction under Regional or general anesthesia and had intraoperative or postoperative complications
Complications like: Deep Venous Thrombosis, Pulmonary complications, Myocardial Infarction and others.
Measured: 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
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 Hip FracturesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhi M. Alghanem, University of Jordan
- Investigators
- Subhi M Alghanem, FFARCS, Study chair, Jordan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692989
- Sponsor's protocol ID
- 268/14a/tk
- Status last verified
- Apr 2016
- First submitted
- 23 Feb 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Urwin SC, Parker MJ, Griffiths R. General versus regional anaesthesia for hip fracture surgery: a meta-analysis of randomized trials. Br J Anaesth. 2000 Apr;84(4):450-5. doi: 10.1093/oxfordjournals.bja.a013468.
PubMed 10823094
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Anesthesia Management for Traumatic Hip Surgery in Elderly: A Retrospective Study in a Tertiary Hospital
- ClinicalTrials.gov ID
- NCT02692989
- Acronym / sponsor ID
- 268/14a/tk
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,270 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 26 Feb 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.
Trauma for hip joint is common in old people. Anesthesia in these types of old patients carries more risk than the adult population.
In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications.
Detailed description
Trauma for hip joint is common in old people; usually trauma for the hip joint is treated surgically under anesthesia. Anesthesia in these types of old patients carries more risk than the adult population, since these type of patients have a lot of chronic diseases which affect their general health.
In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia between the years 2010 to 2015, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications like Deep Venous Thrombosis, Pulmonary complications, myocardial Infarction and others.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who sustained hip fracture and underwent surgical correction under Regional or general anesthesia and had intraoperative or postoperative complications
Key inclusion criteria (2 listed)
- patients who sustained hip fracture.
- patients who underwent surgical correction under Regional or general anesthesia.
Key exclusion criteria (1 listed)
- Patients who sustained Hip fractures but treated conservatively.
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 |
|---|---|---|
| Hip fracture surgery and anesthesiaany operative fixation for hip fracture whether under General Anesthesia or Regional anesthesia | Procedure or surgery | – |
Primary outcome
Number of patients who sustained hip fracture and underwent surgical correction under Regional or general anesthesia and had intraoperative or postoperative complications
Time frame: 30 days post-operative
Complications like: Deep Venous Thrombosis, Pulmonary complications, Myocardial Infarction and others.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Background: PubMed 10823094Urwin SC, Parker MJ, Griffiths R. General versus regional anaesthesia for hip fracture surgery: a meta-analysis of randomized trials. Br J Anaesth. 2000 Apr;84(4):450-5. doi: 10.1093/oxfordjournals.bja.a013468.
- 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.
Subhi M Alghanem, FFARCS study chair
Jordan University
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 Hip Fractures, run by University of Jordan at 1 site in Jordan.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2016. 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 Jordan. 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?
Results are not available in the source record.
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?
Number of patients who sustained hip fracture and underwent surgical correction under Regional or general anesthesia and had intraoperative or postoperative complications (time frame: 30 days post-operative). 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 NCT02692989, 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 5 Apr 2016.