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OpenTrials
Completed

NCT Number: NCT04680572

Functional Outcome After Arthroplasty

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams university hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroplasty

Procedure

arthroplasty for fracture neck of femur

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2020
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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