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Post-Market Study of the ICONACY Hip System

Primary Purpose

Degenerative Joint Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iconacy Hip System
Stryker Accolade Hip System
Sponsored by
Iconacy Orthopedic Implants, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Joint Disease focused on measuring Hip, Arthroplasty, Arthroplasties, Prosthesis, Iconacy, Osteoarthritis, Arthritis, THA, THR, DJD

Eligibility Criteria

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

Inclusion Criteria:

  • This must be a primary hip replacement on this hip
  • Patient is 30 years of age or older
  • Have hip joint disease related to one or more of the following: degenerative joint disease, including osteoarthritis or traumatic arthritis
  • Patient is likely to be available for evaluation for the duration of the study
  • Able and willing to sign the informed consent and follow study procedures

Exclusion Criteria:

  • Is younger than 30 years of age
  • If there has been a total hip replacement on this hip in the past (no revisions allowed in study)
  • Infection, or history of infection, acute or chronic, local or systemic
  • Alcoholism or other addictions
  • Muscular, neurological or vascular deficiencies which compromise the affected extremity
  • Obesity(BMI>45)
  • Insufficient bone quality
  • Loss of ligamentous structures
  • High levels of physical activity
  • Materials sensitivity
  • Prisoner
  • Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
  • Patient is pregnant
  • Is not able to read English language

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Iconacy Hip System

    Stryker Accolade Hip System

    Arm Description

    Iconacy hip system prosthesis components

    Stryker Accolade hip system prosthesis components

    Outcomes

    Primary Outcome Measures

    Radiographic success
    Harris Hip Score must be > or = 80 at 2 years
    Oxford Hip Score > 40 points at 2 years

    Secondary Outcome Measures

    Patient Satisfaction at 1, 2, and 3 years
    Improvement in Harris Hip Score from pre-surgery to 1, 2, and 3 years
    Improvements in Oxford Hip Score from pre-survey to 1, 2, and 3 years

    Full Information

    First Posted
    January 3, 2014
    Last Updated
    May 12, 2014
    Sponsor
    Iconacy Orthopedic Implants, LLC.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02027974
    Brief Title
    Post-Market Study of the ICONACY Hip System
    Official Title
    ICONACY Hip Clinical Data Acquisition (13-1-M-239)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Iconacy Orthopedic Implants, LLC.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for total hip replacement surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Degenerative Joint Disease
    Keywords
    Hip, Arthroplasty, Arthroplasties, Prosthesis, Iconacy, Osteoarthritis, Arthritis, THA, THR, DJD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Iconacy Hip System
    Arm Type
    Active Comparator
    Arm Description
    Iconacy hip system prosthesis components
    Arm Title
    Stryker Accolade Hip System
    Arm Type
    Active Comparator
    Arm Description
    Stryker Accolade hip system prosthesis components
    Intervention Type
    Device
    Intervention Name(s)
    Iconacy Hip System
    Other Intervention Name(s)
    Iconacy I-Hip, I-Hip, iHip
    Intervention Description
    Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.
    Intervention Type
    Device
    Intervention Name(s)
    Stryker Accolade Hip System
    Other Intervention Name(s)
    Accolade
    Intervention Description
    Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.
    Primary Outcome Measure Information:
    Title
    Radiographic success
    Time Frame
    2 years
    Title
    Harris Hip Score must be > or = 80 at 2 years
    Time Frame
    2 years
    Title
    Oxford Hip Score > 40 points at 2 years
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Patient Satisfaction at 1, 2, and 3 years
    Time Frame
    1, 2, and 3 years
    Title
    Improvement in Harris Hip Score from pre-surgery to 1, 2, and 3 years
    Time Frame
    1, 2, and 3 years
    Title
    Improvements in Oxford Hip Score from pre-survey to 1, 2, and 3 years
    Time Frame
    1, 2, and 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: This must be a primary hip replacement on this hip Patient is 30 years of age or older Have hip joint disease related to one or more of the following: degenerative joint disease, including osteoarthritis or traumatic arthritis Patient is likely to be available for evaluation for the duration of the study Able and willing to sign the informed consent and follow study procedures Exclusion Criteria: Is younger than 30 years of age If there has been a total hip replacement on this hip in the past (no revisions allowed in study) Infection, or history of infection, acute or chronic, local or systemic Alcoholism or other addictions Muscular, neurological or vascular deficiencies which compromise the affected extremity Obesity(BMI>45) Insufficient bone quality Loss of ligamentous structures High levels of physical activity Materials sensitivity Prisoner Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements Patient is pregnant Is not able to read English language
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William A Hodge, MD
    Organizational Affiliation
    Eastern Maine Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Post-Market Study of the ICONACY Hip System

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