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Dual Mobility Cup: Does it Improve Patient's Satisfaction After Total Hip Arthroplastry?

Primary Purpose

Patient Satisfaction, Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
large head
dual mobility cup
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patient Satisfaction focused on measuring hip arthroplasty, satisfaction, dual mobility cup

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Unilateral hip arthritis
  • Age up to 65 years
  • Body mass index (BMI) up to 35
  • Modified Charnley comorbidity classification equal to A

Exclusion Criteria:

  • Neurological deficit (e.g. Parkinsonism, stroke)
  • Bone type c not fit for cementless fixation
  • Poly-arthritis, active inflammatory arthritis (e.g. rheumatoid arthritis)
  • Any patient with psychiatric disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    large head group

    dual mobility group

    Arm Description

    study the postoperative patient's satisfaction

    study the postoperative patient's satisfaction

    Outcomes

    Primary Outcome Measures

    patient's satisfaction
    measurement by patient's reported outcomes measures
    clinical evaluation
    WOMAC score
    pain assessment
    VAS score

    Secondary Outcome Measures

    Full Information

    First Posted
    March 30, 2020
    Last Updated
    April 1, 2020
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04333316
    Brief Title
    Dual Mobility Cup: Does it Improve Patient's Satisfaction After Total Hip Arthroplastry?
    Official Title
    Principal Investigator
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (Actual)
    Primary Completion Date
    August 2018 (Actual)
    Study Completion Date
    August 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Although the success of total hip arthroplasty, many patients were dissatisfied postoperatively. Patient's reported outcome measures become of a great importance in assessment of the results after joint replacement. The aim of this prospective study is to evaluate and compare postoperative patient's satisfaction after implantation of two commonly used different designs of total hip arthroplasty.
    Detailed Description
    The investigators conducted a prospective comparative study carried out on 180 patients suffering of hip arthritis between 2011 and 2018. They were randomized into two groups of homogenous demographic and clinical data. Group A was treated by cementless T.H.A. with a large head while group B received cementless T.H.A. with a dual mobility cup. Clinical evaluation and preoperative patient's expectation were assessed and compared to the postoperative satisfaction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patient Satisfaction, Hip Osteoarthritis
    Keywords
    hip arthroplasty, satisfaction, dual mobility cup

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is prospective study was carried out on 180 patients with a unilateral arthritic hip between January 2011 and August 2018. Patients were divided into two groups, each group included 90 patients. Group A included patients received total hip with a large head (32-36mm.) made of cobalt-chrome. The femoral component was a cementless porous coated stem. The cup was a cementless porous coated Trilogy cup and was inserted press fit with primary additional one to three screws. Group B included those received total hip with a dual mobility cup
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    large head group
    Arm Type
    Other
    Arm Description
    study the postoperative patient's satisfaction
    Arm Title
    dual mobility group
    Arm Type
    Other
    Arm Description
    study the postoperative patient's satisfaction
    Intervention Type
    Procedure
    Intervention Name(s)
    large head
    Intervention Description
    implantation of large head total hip
    Intervention Type
    Procedure
    Intervention Name(s)
    dual mobility cup
    Intervention Description
    implantation of dual mobility total hip
    Primary Outcome Measure Information:
    Title
    patient's satisfaction
    Description
    measurement by patient's reported outcomes measures
    Time Frame
    about 5 years
    Title
    clinical evaluation
    Description
    WOMAC score
    Time Frame
    about 5 years
    Title
    pain assessment
    Description
    VAS score
    Time Frame
    about 5 years

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Unilateral hip arthritis Age up to 65 years Body mass index (BMI) up to 35 Modified Charnley comorbidity classification equal to A Exclusion Criteria: Neurological deficit (e.g. Parkinsonism, stroke) Bone type c not fit for cementless fixation Poly-arthritis, active inflammatory arthritis (e.g. rheumatoid arthritis) Any patient with psychiatric disorders

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We conducted a prospective comparative study carried out on 180 patients suffering of hip arthritis between 2011 and 2018. They were randomized into two groups of homogenous demographic and clinical data. Group A was treated by cementless T.H.A. with a large head while group B received cementless T.H.A. with a dual mobility cup. Clinical evaluation and preoperative patient's expectation were assessed and compared to the postoperative satisfaction
    Citations:
    PubMed Identifier
    33252552
    Citation
    Samy AM, Mahmoud AA, El-Tantawy A. Dual Mobility Cup: Does It Improve Patient's Satisfaction After Total Hip Arthroplasty? A Prospective Comparative Randomized Study. J Am Acad Orthop Surg. 2021 Nov 15;29(22):e1141-e1150. doi: 10.5435/JAAOS-D-20-00882.
    Results Reference
    derived

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