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Evaluation of a New Coating in Cement Less Femoral Stems

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Taperloc
Sponsored by
Lars Nordsletten
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants

Exclusion Criteria:

  • infection, revision surgery, severe morbidity and obvious bone loss

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Bonemaster

    Hydroxyapatite

    Arm Description

    Cement-less femoral stems with electrochemical deposition of hydroxyapatite

    Cement-less femoral stems with plasmasprayed hydroxyapatite

    Outcomes

    Primary Outcome Measures

    Early and intermediate periprosthetic bone remodeling
    Bone densitometry measured by DXA
    Early and intermediate femoral stem stability
    Radiostereometric analysis of femoral stem movements relative to bone

    Secondary Outcome Measures

    Clinical function
    Hip questionares, Harris Hip Score and Oxford Hip Score
    Radiographic signs of loosening
    Conventional x-ray

    Full Information

    First Posted
    December 17, 2014
    Last Updated
    December 17, 2014
    Sponsor
    Lars Nordsletten
    Collaborators
    Zimmer Biomet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02321683
    Brief Title
    Evaluation of a New Coating in Cement Less Femoral Stems
    Official Title
    No Mid-term Advantage by Electrochemical Deposition of Hydroxyl-apatite in Cementless Femoral Stems. 5-year RSA and DXA Results From a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Lars Nordsletten
    Collaborators
    Zimmer Biomet

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.
    Detailed Description
    60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. This patients will be followed for at least 5 years. The outcome is evaluated by comparing stability measured by RSA and periprosthetic bone remodeling measured by bone densitometry.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bonemaster
    Arm Type
    Experimental
    Arm Description
    Cement-less femoral stems with electrochemical deposition of hydroxyapatite
    Arm Title
    Hydroxyapatite
    Arm Type
    Active Comparator
    Arm Description
    Cement-less femoral stems with plasmasprayed hydroxyapatite
    Intervention Type
    Device
    Intervention Name(s)
    Taperloc
    Intervention Description
    Femoral stem with electrochemical deposition of hydroxyapatite
    Primary Outcome Measure Information:
    Title
    Early and intermediate periprosthetic bone remodeling
    Description
    Bone densitometry measured by DXA
    Time Frame
    5 years
    Title
    Early and intermediate femoral stem stability
    Description
    Radiostereometric analysis of femoral stem movements relative to bone
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    Clinical function
    Description
    Hip questionares, Harris Hip Score and Oxford Hip Score
    Time Frame
    5 years
    Title
    Radiographic signs of loosening
    Description
    Conventional x-ray
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants Exclusion Criteria: infection, revision surgery, severe morbidity and obvious bone loss

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26364953
    Citation
    Flatoy B, Rohrl SM, Boe B, Nordsletten L. No medium-term advantage of electrochemical deposition of hydroxyapatite in cementless femoral stems. 5-year RSA and DXA results from a randomized controlled trial. Acta Orthop. 2016 Feb;87(1):42-7. doi: 10.3109/17453674.2015.1084768. Epub 2015 Sep 12.
    Results Reference
    derived

    Learn more about this trial

    Evaluation of a New Coating in Cement Less Femoral Stems

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