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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03875014
Other study ID # AKUP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date December 31, 2018

Study information

Verified date March 2019
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is conducted with the aim to compare the functional outcome, rate of dislocation, complications and mortality after treatment of displaced neck of femur fracture with bipolar hemiarthroplasty or total hip arthroplasty with dual mobility cuff.


Description:

This study is conducted with the aim to compare the functional outcome, rate of dislocation, complications and mortality after treatment of displaced neck of femur fracture with bipolar hemiarthroplasty or total hip arthroplasty with dual mobility cuff.

This study is conducted with the aim to compare the functional outcome, rate of dislocation, complications and mortality after treatment of displaced neck of femur fracture with bipolar hemiarthroplasty or total hip arthroplasty with dual mobility cuff.

A retrospective cohort study will be conducted at our tertiary care level 1 trauma center .ERC approval wwill taken from Ethical Review Committee of the hospital. Patients of age group more than 60 year who underwent hip arthroplasty (bipolar hemiarthroplasty or THA with dual mobility implant) between 2015 and 2017 for displaced neck of femur fracture with a complete follow up for one year were included.

Both groups will be assessed for postoperative complications including surgical complications (dislocation, periprosthetic fracture and surgical site infection), one year mortality and functional outcome via Harris hip score at the latest follow up.

Data will be analyzed using SPSS version 20.Chi-sqaure test was used to compare categorical variables whereas independent sample T-test was used to compare continuous variables. P-value of <0.05 was considered significant


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date December 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- . Patients of age group more than 60 year who underwent hip arthroplasty (bipolar hemiarthroplasty or THA with dual mobility implant) between 2015 and 2017 for displaced neck of femur fracture with a complete follow up for one year

Exclusion Criteria:

- Patient who underwent hip arthroplasty for other indications, patients younger than 60 years patient with pathological fractures, patient with missing records and patients lost to follow up

Study Design


Related Conditions & MeSH terms


Intervention

Device:
surgery with implant for hip fracture
hip replacement with bipolar hemiarthroplasty or total hip arthroplasty dual mobility done and patients was followed

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aga Khan University

Outcome

Type Measure Description Time frame Safety issue
Primary mortality death within one year of index surgery one year
Secondary functional outcome harris hip score used to determine functional outcome one year
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