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Functional Outcome After Arthroplasty

NCT ID: NCT04680572

Last Updated: 2020-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-09-30

Brief Summary

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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

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Conditions

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Fracture Neck of Femur

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bipolar hemiarthroplasty group

Group Type ACTIVE_COMPARATOR

arthroplasty

Intervention Type PROCEDURE

arthroplasty for fracture neck of femur

Dual mobility cups total hip replacement group

Group Type ACTIVE_COMPARATOR

arthroplasty

Intervention Type PROCEDURE

arthroplasty for fracture neck of femur

Interventions

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arthroplasty

arthroplasty for fracture neck of femur

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Tony Maher

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ibrahim M Ganzoury, professor

Role: STUDY_DIRECTOR

Faculty of Medicine Ain Shams university

Locations

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Ain Shams university hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MD thesis protocol

Identifier Type: -

Identifier Source: org_study_id