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Clinical Trials/NCT04680572
NCT04680572CompletedNot Applicable

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

Ain Shams University1 site in 1 country33 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
1
Primary Endpoint
functional outcome using the Harris hip score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
60 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Bipolar hemiarthroplasty group

Active Comparator

Intervention: arthroplasty (Procedure)

Dual mobility cups total hip replacement group

Active Comparator

Intervention: arthroplasty (Procedure)

Outcomes

Primary Outcomes

functional outcome using the Harris hip score

Time Frame: 2 years

hip joint range of motion and activities of daily living

rate of dislocation

Time Frame: 2 years

postoperative prosthesis dislocation

Secondary Outcomes

  • operative time in minutes(45 minutes to 2 hours)
  • blood loss in cc(during the procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tony Maher

Assistant lecturer

Ain Shams University

Study Sites (1)

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