Back to results

Functional Outcome After Arthroplasty

Primary Purpose

Fracture Neck of Femur

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

arthroplasty

About this trial

This is an interventional treatment trial for Fracture Neck of Femur

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ain Shams university hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Bipolar hemiarthroplasty group

Dual mobility cups total hip replacement group

Arm Description

Outcomes

Primary Outcome Measures

functional outcome using the Harris hip score

hip joint range of motion and activities of daily living

rate of dislocation

postoperative prosthesis dislocation

Secondary Outcome Measures

operative time in minutes

the time needed to perform the procedure

blood loss in cc

the amount of blood loss during the procedure

Full Information

NCT ID

NCT04680572

First Posted

December 13, 2020

Last Updated

December 17, 2020

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04680572

Brief Title

Functional Outcome After Arthroplasty

Official Title

Functional Outcome After Dual Mobility Cups Total Hip Replacement Versus Bipolar Hemiarthroplasty in Fracture Neck of Femur in Active Elderly Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

September 1, 2020 (Actual)

Study Completion Date

September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fracture Neck of Femur

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bipolar hemiarthroplasty group

Arm Type

Active Comparator

Arm Title

Dual mobility cups total hip replacement group

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

arthroplasty

Intervention Description

arthroplasty for fracture neck of femur

Primary Outcome Measure Information:

Title

functional outcome using the Harris hip score

Description

hip joint range of motion and activities of daily living

Time Frame

2 years

Title

rate of dislocation

Description

postoperative prosthesis dislocation

Time Frame

2 years

Secondary Outcome Measure Information:

Title

operative time in minutes

Description

the time needed to perform the procedure

Time Frame

45 minutes to 2 hours

Title

blood loss in cc

Description

the amount of blood loss during the procedure

Time Frame

during the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ibrahim M Ganzoury, professor

Organizational Affiliation

Faculty of Medicine Ain Shams university

Official's Role

Study Director

Facility Information:

Facility Name

Ain Shams university hospitals

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

demographic data and radiographs

Learn more about this trial

Functional Outcome After Arthroplasty

We'll reach out to this number within 24 hrs