Outcome, FatalNCT03875027
Outcome of Proximal Femur Replacement at a Tertiary Care Hospital
An observational study of Outcome, Fatal, run by Aga Khan University.
Trial summary
This is a retrospective review of all patients who underwent PFR for either bipolar hemiarthroplasty or total hip replacement Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Outcome, Fatal
- What is being tested?
- proximal femur replacement
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Dec 2018
- 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: patient underwent proximal femur replacement
Who may be able to join
- All patients, regardless of race, gender, age and co-morbids, who were treated with proximal femur fracture with any of the following variables:
- Poor bone quality Bone loss Severe communition Multiple comorbids Failed hip surgery Pathological fractures
Who cannot join
- The patient who weren't treated with proximal femoral replacemnt, those lost to follow up, those with missing record.
About this study
This is a retrospective review of all patients who underwent PFR for either bipolar hemiarthroplasty or total hip replacement
Read the detailed description
retrospective review of all patients who underwent PFR for either bipolar hemiarthroplasty or total hip replacement will be conducted All patients that fall in the selection criteria from 2009 to 2018 will be included as part of this study will be selected Patients are identified using medical record numbers. A questionnaire containing questions on demographics of the patients which includes their age, sex and co morbids. Furthermore, the cause of fracture, time from the fracture to presentation in the emergency room, time from the presentation to ER to the time patient was in the operating room would be noted. Duration of the surgery.
The weight bearing status in the ward and follow-up would be noted. Functionality of the patient; which is that how much patients are able to carry their normal daily routine work would also be noted from the medical records.
Collected data will be analysed using Statistical Package for Social Sciences (SPSS, Inc, Chicago, IL, USA). Results will be recorded as frequencies, means, Standard Deviation (SD) and p-values while statistical tests will be applied for comparative reasons. For all purposes a p-value of 0.05 will be considered as the level of significance.
- Conditions
- Outcome, Fatal
- Being tested
- proximal femur replacement
- Keywords
- proximal femur, functional outcome, fracture, failed hip surgery
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal femur replacementProcedure or surgery
patient with proximal femur fracture or those in whom previous surgery on hip is failed and treated with replacement of proximal femur implant
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome
improvement in functional claculated via harris hip score
Measured: 2009 till 2018
Secondary outcomes (1)
mortality
death within one of year of surgery
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Jan 2009
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome, FatalStudies 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
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shah fahad, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875027
- Sponsor's protocol ID
- akupd
- Status last verified
- Mar 2019
- First submitted
- 13 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Proximal Femur Replacement at a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT03875027
- Acronym / sponsor ID
- akupd
- Conditions
- Outcome, Fatal
- Keywords
- proximal femur, functional outcome, fracture, failed hip surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Mar 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.
This is a retrospective review of all patients who underwent PFR for either bipolar hemiarthroplasty or total hip replacement
Detailed description
retrospective review of all patients who underwent PFR for either bipolar hemiarthroplasty or total hip replacement will be conducted All patients that fall in the selection criteria from 2009 to 2018 will be included as part of this study will be selected Patients are identified using medical record numbers. A questionnaire containing questions on demographics of the patients which includes their age, sex and co morbids. Furthermore, the cause of fracture, time from the fracture to presentation in the emergency room, time from the presentation to ER to the time patient was in the operating room would be noted. Duration of the surgery.
The weight bearing status in the ward and follow-up would be noted. Functionality of the patient; which is that how much patients are able to carry their normal daily routine work would also be noted from the medical records.
Collected data will be analysed using Statistical Package for Social Sciences (SPSS, Inc, Chicago, IL, USA). Results will be recorded as frequencies, means, Standard Deviation (SD) and p-values while statistical tests will be applied for comparative reasons. For all purposes a p-value of 0.05 will be considered as the level of significance.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient underwent proximal femur replacement
Key inclusion criteria (2 listed)
- All patients, regardless of race, gender, age and co-morbids, who were treated with proximal femur fracture with any of the following variables:
- Poor bone quality Bone loss Severe communition Multiple comorbids Failed hip surgery Pathological fractures
Key exclusion criteria (1 listed)
- The patient who weren't treated with proximal femoral replacemnt, those lost to follow up, those with missing record.
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 |
|---|---|---|
| proximal femur replacementpatient with proximal femur fracture or those in whom previous surgery on hip is failed and treated with replacement of proximal femur implant | Procedure or surgery | – |
Primary outcome
functional outcome
Time frame: 2009 till 2018
improvement in functional claculated via harris hip score
1 secondary outcome
mortality
Time frame: one year
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 15 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Outcome, Fatal
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Russian Registry of Surgical OutcomeS
Surgery, Anesthesia
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 Outcome, Fatal, 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 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: finished, as of the sponsor's last update on 15 Mar 2019. 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?
functional outcome (time frame: 2009 till 2018). 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 15 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.