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Functional Outcome After Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04680572
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Tony Maher, Ain Shams University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fracture Neck of Femur Procedure: arthroplasty Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Outcome After Dual Mobility Cups Total Hip Replacement Versus Bipolar Hemiarthroplasty in Fracture Neck of Femur in Active Elderly Patients
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. functional outcome using the Harris hip score [ Time Frame: 2 years ]
    hip joint range of motion and activities of daily living

  2. rate of dislocation [ Time Frame: 2 years ]
    postoperative prosthesis dislocation


Secondary Outcome Measures :
  1. operative time in minutes [ Time Frame: 45 minutes to 2 hours ]
    the time needed to perform the procedure

  2. blood loss in cc [ Time Frame: during the procedure ]
    the amount of blood loss during the procedure


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680572


Locations
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Egypt
Ain Shams university hospitals
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Ibrahim M Ganzoury, professor Faculty of Medicine Ain Shams university
  Study Documents (Full-Text)

Documents provided by Tony Maher, Ain Shams University:
Study Protocol and Statistical Analysis Plan  [PDF] September 4, 2018

More Information
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Responsible Party: Tony Maher, Assistant lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT04680572    
Other Study ID Numbers: MD thesis protocol
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: demographic data and radiographs
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Femoral Neck Fractures
Fractures, Bone
Wounds and Injuries
Hip Fractures
 Femoral Fractures
Hip Injuries
Leg Injuries