Functional Outcome After Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Fracture Neck of Femur
• Intervention / Treatment: Procedure: arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bipolar hemiarthroplasty group	Procedure: arthroplasty; arthroplasty for fracture neck of femur
Active Comparator: Dual mobility cups total hip replacement group	Procedure: arthroplasty; arthroplasty for fracture neck of femur

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	during the procedure

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Ibrahim M Ganzoury, professor, Faculty of Medicine Ain shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: MD thesis protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: demographic data and radiographs
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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