Multi-Site, Post-Market Study of the ICONACY I-Hip System

May 2, 2014 updated by: Iconacy Orthopedic Implants, LLC.

Non-Randomized, Multi-Site, Post-Market Study of the ICONACY I-Hip System (Protocol No. PS-1001)

The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total hip replacement surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Baptist Health Louisville
        • Contact:
        • Principal Investigator:
          • Donald L Pomeroy, MD
      • Louisville, Kentucky, United States, 40215
        • Recruiting
        • Sts. Mary & Elizabeth Hospital - KentuckyOne Health
        • Contact:
        • Principal Investigator:
          • Donald L Pomeroy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A candidate for primary hip replacement on this operative hip.
  • Is 30 to 80 years of age.

  • Has hip joint disease related to one or more of the following:

    • Degenerative joint disease, (including osteoarthritis or post-traumatic arthritis)
    • Avascular Necrosis (AVN).
  • Will be available for evaluation for the duration of the study.
  • Is able and willing to speak and read English, read and sign the informed consent, fill out the WOMAC and Patient Satisfaction questionnaires, and follow all study procedures.

Exclusion Criteria:

  • Is younger than 30 years of age or older than 80 years of age.
  • Has undergone partial hip replacement or previous ORIF (open reduction internal fixation of femur or acetabulum).
  • Has undergone total hip replacement on this hip in the past (no revisions allowed in study).
  • Infection, or history of infection, acute or chronic, in the hip joint, or acute or chronic unresolved systemic infection.
  • Is currently experiencing radicular pain from the spine down operative leg.
  • Has participated in an IDE/IND clinical investigation with an investigational product in the last three months, or is involved in any personal injury litigation, medical-legal or worker's compensation claim.
  • Is a known drug or alcohol abuser or has a psychological disorder that could affect the ability to complete patient reported questionnaires.
  • Has been diagnosed with fibromyalgia or has a significant neurological or musculoskeletal disorder or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
  • Has been diagnosed with Paget's disease or Congenital hip deformity (dysplasia and/or dislocation).
  • Is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.)
  • Is Obese: (Defined for this study as having a BMI>45).
  • Has insufficient bone quality.
  • Has loss of ligamentous structures.
  • Has materials sensitivity.
  • Is currently a prisoner.
  • Is pregnant or lactating.
  • Has a contralateral amputation.
  • Has a medical condition with less than 2 years of life expectancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Iconacy Hip System
Iconacy hip system prosthesis components
Device: Iconacy Hip System
Other Names:
  • Iconacy I-Hip
  • I-Hip
  • iHip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Success as a Measure of Radiolucency and Component Migration
Time Frame: 2 years

A subject will be considered a failure for Overall Radiographic Success if one or more of the below conditions are met:

The subject will be considered a RADIOGRAPHIC FAILURE if:

  1. there is a complete radiolucent line> 3mm wide at the bone/cement interface or
  2. there is a >5 degree migration (shift) of the component or
  3. there is a >5 mm migration (shift) of the component.
2 years
Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered)
Time Frame: 2 years
2 years
Patient satisfaction clinical assessment utilizing questionnaire
Time Frame: 2 years
Clinical assessment of patient satisfaction will be made by utilizing a Patient Satisfaction (PS) questionnaire.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Revision of Implant Prosthesis as a Measure of Efficacy
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iconacy Orthopedic Implants, LLC.

Investigators

  • Principal Investigator: Donald L Pomeroy, MD, Pomeroy & Rhoads Orthopaedics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 2, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS-1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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