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Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old

Primary Purpose

Hip Replacement, Total, Osteonecrosis of Femoral Head, Coxarthrosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Total hip replacement
Sponsored by
Ewha Womans University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Replacement, Total

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • End stage hip arthritis

Exclusion Criteria:

  • Age above 50 years old
  • Inflammatory arthritis
  • Coexisting foot or ankle disorder limiting walking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Conventional stem

    Ultra-Short stem

    Arm Description

    total hip replacement operated with conventional stem (Profile; DePuy, Leeds, United Kingdom)

    total hip replacement operated with ultra-short stem (Proxima; DePuy, Leeds, United Kingdom)

    Outcomes

    Primary Outcome Measures

    Thigh pain
    thigh pain,in visual analog scale 0 to 10.

    Secondary Outcome Measures

    Harris hip score

    Full Information

    First Posted
    January 12, 2015
    Last Updated
    January 13, 2015
    Sponsor
    Ewha Womans University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02338596
    Brief Title
    Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old
    Official Title
    Comparison of the Outcomes of Ultra-Short Anatomic and Conventional Cementless Stems in Patients Younger Than Fifty-Five Years Old
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2001 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    As clinical and radiographic performance of an ultra-short anatomic cementless stem have been investigated only two randomized controlled studies, well-designed trials should aim for a thorough comparison of the outcomes of ultra-short and conventional cementless stems. The purpose of this study was to compare the outcomes of ultra-short and conventional stems in the same young patients who underwent simultaneous bilateral sequential total hip arthroplasties.
    Detailed Description
    Conventional cementless femoral stems are known to provide a high rate of satisfactory clinical outcomes at long-term follow-ups. However, they may have potential clinical consequences related to stress shielding, thigh pain, periprosthetic fractures, proximal/distal dimensional mismatch, an easier access pathway for wear debries and removal during revision. In an effort to reduce the risk of stress shielding, thigh pain, periprosthetic fracture, proximal/distal stem mismatch, and to facilitate removal of well fixed stem, a new ultra-short anatomic metaphyseal-fitting cementless femoral stem was developed. It was designed to provide closely mimicking the original functioning hip. The absence of the diaphyseal anchorage attempt proximal load transfer to reduce stress shielding, thigh pain and proximal distal/mismatch. Furthermore, it attempts to preservation of the femoral canal and femoral elasticity and ease of revision. The question thus arises whether it is possible to obtain strong and long-lasting fixation of the femoral component without diaphyseal anchoring. As clinical and radiographic performances of this ultra-short stem have been investigated only in a few studies and at short-term follow-ups, it remains to be elucidated whether an ultra-short stem shows a low incidence of implant loosening, stem misalignment, intraoperative fractures and revision rate. The purpose of this randomized controlled study to compare: (1) the clinical results, including Harris hip score, thigh pain, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index score, and patients' satisfaction; (2) radiographic results, including stress shielding, implant loosening, stem misalignment; and (3) intraoperative fractures and revision rates of cementless total hip arthroplasty using an ultra-short anatomic metaphyseal-fitting cementless femoral stem versus a conventional metaphyseal and diaphyseal fitting anatomi proximal porous-coated cementless stem in the same patients who underwent bilateral simultaneous sequential total hip arthroplasty under one anesthetic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Replacement, Total, Osteonecrosis of Femoral Head, Coxarthrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    111 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional stem
    Arm Type
    Experimental
    Arm Description
    total hip replacement operated with conventional stem (Profile; DePuy, Leeds, United Kingdom)
    Arm Title
    Ultra-Short stem
    Arm Type
    Active Comparator
    Arm Description
    total hip replacement operated with ultra-short stem (Proxima; DePuy, Leeds, United Kingdom)
    Intervention Type
    Procedure
    Intervention Name(s)
    Total hip replacement
    Intervention Description
    Simultaneous bilateral sequential total hip arthroplasties under the same anesthetic. Randomization to treatment with an ultra-short or a convnetional cementless stem was accomplished with use of study numbers in sealed envelope, which were opened in the operating room before the skin incision was made. The pore size was 250㎛. A 28-mm-diameter Biolox forte ceramic femoral head (CeramTec AG, Polchingen, Germany) ) was used in all hips. A cementless cup and a 28mm internal-diameter Biolox forte ceramic liner was used in all hips in both groups.
    Primary Outcome Measure Information:
    Title
    Thigh pain
    Description
    thigh pain,in visual analog scale 0 to 10.
    Time Frame
    10 year after the operation
    Secondary Outcome Measure Information:
    Title
    Harris hip score
    Time Frame
    10 year after the operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: End stage hip arthritis Exclusion Criteria: Age above 50 years old Inflammatory arthritis Coexisting foot or ankle disorder limiting walking
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Young-Hoo Kim, M.D.
    Organizational Affiliation
    Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old

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