Hip FracturesNCT04187261
Audit of Hip Fractures Surgically Managed
An observational study of Hip Fractures, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Investigators are reviewing the the charts and medical records of participants who were operated at our institute from 2010 onward for hip fractures. Checking their outcomes (Postoperative complications, length of hospital stay and mortality) and studying their background characteristics and potential associated… Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- hip fracture surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2010to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: mostly elderly with hi fractures. However we included young patients as well.
Who may be able to join
- All patients, regardless of gender, commodities and age
- Hip fractures which were managed surgically.
- operated at our institute.
Who cannot join
- Participants with incomplete data or missing information in either the primary exposure or the outcome of interest.
- Participants with pathological fracture, open fractures, poly-trauma or revision surgeries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
aziz hayder, bachelor, 02134864350, aziz.hayder@aku.edu
About this study
Official title: Hip Fractures Surgical Management and Complications: Retrospective Study
Investigators are reviewing the the charts and medical records of participants who were operated at our institute from 2010 onward for hip fractures. Checking their outcomes (Postoperative complications, length of hospital stay and mortality) and studying their background characteristics and potential associated factors.
Read the detailed description
This retrospective study is a cohort with multiple exposures and groups. From this nested case control will be analysed as well.
- Conditions
- Hip Fractures
- Being tested
- hip fracture surgeries
- 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 surgeriesProcedure or surgery
fixation or replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
minor or major, in-hospital or within 30 days postoperativel
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jan 2010
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Obada Hasan, FCPS, MRCS, MSc (Epidemiology&Biostatistics), Aga Khan University
- Investigators
- Obada Hasan, FCPS, MSc, Principal investigator, Aga Khan Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187261
- Sponsor's protocol ID
- 4543 21-dec-16
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not allowed by organisation
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Fractures Surgical Management and Complications: Retrospective Study
- ClinicalTrials.gov ID
- NCT04187261
- Acronym / sponsor ID
- 4543 21-dec-16
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Dec 2019 (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.
Investigators are reviewing the the charts and medical records of participants who were operated at our institute from 2010 onward for hip fractures. Checking their outcomes (Postoperative complications, length of hospital stay and mortality) and studying their background characteristics and potential associated factors.
Detailed description
This retrospective study is a cohort with multiple exposures and groups. From this nested case control will be analysed as well.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- mostly elderly with hi fractures. However we included young patients as well.
Key inclusion criteria (3 listed)
- All patients, regardless of gender, commodities and age
- Hip fractures which were managed surgically.
- operated at our institute.
Key exclusion criteria (2 listed)
- Participants with incomplete data or missing information in either the primary exposure or the outcome of interest.
- Participants with pathological fracture, open fractures, poly-trauma or revision surgeries.
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 surgeriesfixation or replacement | Procedure or surgery | – |
Primary outcome
postoperative complications
Time frame: 30 days postoperative
minor or major, in-hospital or within 30 days postoperativel
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No. not allowed by organisation
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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.
Obada Hasan, FCPS, MSc principal investigator
Aga Khan Univeristy
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 Aga Khan University at 1 site in Pakistan.
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 3 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: looking for participants now, as of the sponsor's last update on 13 Dec 2019. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Obada Hasan, FCPS,MSc (3193567121, obada.husseinali@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: 30 days postoperative). 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 13 Dec 2019.