- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03875027
Outcome of Proximal Femur Replacement at a Tertiary Care Hospital
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- The patient who weren't treated with proximal femoral replacemnt, those lost to follow up, those with missing record.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional outcome
Time Frame: 2009 till 2018
|
improvement in functional claculated via harris hip score
|
2009 till 2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mortality
Time Frame: one year
|
death within one of year of surgery
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- akupd
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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