Comparison of Bipolar Hemiarthroplasty and Total Hip Arth... | NCT03875014

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

NCT03875014

Sponsor

Aga Khan University

Status

Completed

Last Update Posted

Mar 15, 2019Actual

Enrollment

104Actual

Phase

Not provided

Conditions

Dislocations

Interventions

surgery with implant for hip fracture

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Mar 13, 2019

First Submission Date that Met QC Criteria

Mar 13, 2019

First Posted Date

Mar 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2019

Last Update Posted Date

Mar 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1		Bipolar hemiarthroplasty grop	Device: surgery with implant for hip fracture
group 2		Total hip replacement dual mobility group	Device: surgery with implant for hip fracture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery with implant for hip fracture	Device	hip replacement with bipolar hemiarthroplasty or total hip arthroplasty dual mobility done and patients was followed	group 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004204	Joint Dislocations

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative
D016254	Mutagenesis, Insertional

Ancestor Terms

ID	Term
D015202	Protein Engineering
D005818	Genetic Engineering
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided