Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Dual Mobility Cup

Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Dual Mobility Cup in the Treatment of Old Active Patients With Displaced Neck of Femur Fracture

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.

Study Overview

• Status: Completed
• Conditions: Dislocations
• Intervention / Treatment: Device: surgery with implant for hip fracture

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 104

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

. Patients of age group more than 60 years old with hip fracture treated via bipolar hemiarthroplasty or total hip replacement with dual mobility cup

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1; Bipolar hemiarthroplasty grop	Device: surgery with implant for hip fracture; hip replacement with bipolar hemiarthroplasty or total hip arthroplasty dual mobility done and patients was followed
group 2; Total hip replacement dual mobility group	Device: surgery with implant for hip fracture; hip replacement with bipolar hemiarthroplasty or total hip arthroplasty dual mobility done and patients was followed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	death within one year of index surgery	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional outcome	harris hip score used to determine functional outcome	one year

Collaborators and Investigators

• Sponsor: Aga Khan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (ACTUAL): March 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: dual mobility cup; dislocation; total hip repcament; bipolar hemiarthroplasty
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: AKUP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No