Functional Outcome After Arthroplasty | NCT04680572

Studies
Functional Outcome After Arthroplasty

NCT04680572

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Dec 23, 2020Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Fracture Neck of Femur

Interventions

arthroplasty

Countries

Egypt

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

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, 2018Actual

Primary Completion Date

Sep 1, 2020Actual

Completion Date

Sep 30, 2020Actual

First Submitted Date

Dec 13, 2020

First Submission Date that Met QC Criteria

Dec 17, 2020

First Posted Date

Dec 23, 2020Actual

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

Dec 17, 2020

Last Update Posted Date

Dec 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Bipolar hemiarthroplasty (BA) has long been the preferred treatment and is performed in most fracture neck of femur (FNF) cases. It is justified by the reasonable operative time, low blood loss and acceptable functional outcomes. The dual mobility cup total hip replacement (DMTHA) has emerged as a relevant alternative to BA. Since then, there is an on-going debate on the best implant to use. Age, co-morbidities, patient independence and potential surgical complications must be considered when deciding between implants. The risk of dislocation is a crucial factor because of its important consequences. The investigators evaluated the functional and mechanical outcomes of BA versus DMTHA in FNF in active elderly patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bipolar hemiarthroplasty group	Active Comparator		Procedure: arthroplasty
Dual mobility cups total hip replacement group	Active Comparator		Procedure: arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
arthroplasty	Procedure	arthroplasty for fracture neck of femur	Bipolar hemiarthroplasty group Dual mobility cups total hip replacement group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
functional outcome using the Harris hip score	hip joint range of motion and activities of daily living	2 years
rate of dislocation	postoperative prosthesis dislocation	2 years

Secondary Outcomes

Measure	Description	Time Frame
operative time in minutes	the time needed to perform the procedure	45 minutes to 2 hours
blood loss in cc	the amount of blood loss during the procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

active patients
displaced fracture neck of femur
age from 60 to 80

Exclusion Criteria:

ipsilateral previous hip surgery
grade 3 hip osteoarthritis according to tonnis classifiction
dysplastic acetabulum

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ibrahim M Ganzoury, professor	Faculty of Medicine Ain Shams university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams university hospitals		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

demographic data and radiographs

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 4, 2018	Dec 17, 2020	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D005265	Femoral Neck Fractures

Ancestor Terms

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001178	Arthroplasty

Ancestor Terms

ID	Term
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative
D019651	Plastic Surgery Procedures

Browse Leaves

Not provided

Browse Branches

Not provided