Post-Market Study of the ICONACY Hip System

May 12, 2014 updated by: Iconacy Orthopedic Implants, LLC.

ICONACY Hip Clinical Data Acquisition (13-1-M-239)

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Iconacy Hip System
Iconacy hip system prosthesis components
Device: Iconacy Hip System
Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.
Other Names:
  • Iconacy I-Hip
  • I-Hip
  • iHip
ACTIVE_COMPARATOR: Stryker Accolade Hip System
Stryker Accolade hip system prosthesis components
Device: Stryker Accolade Hip System
Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.
Other Names:
  • Accolade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic success
Time Frame: 2 years
2 years
Harris Hip Score must be > or = 80 at 2 years
Time Frame: 2 years
2 years
Oxford Hip Score > 40 points at 2 years
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Satisfaction at 1, 2, and 3 years
Time Frame: 1, 2, and 3 years
1, 2, and 3 years
Improvement in Harris Hip Score from pre-surgery to 1, 2, and 3 years
Time Frame: 1, 2, and 3 years
1, 2, and 3 years
Improvements in Oxford Hip Score from pre-survey to 1, 2, and 3 years
Time Frame: 1, 2, and 3 years
1, 2, and 3 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: William A Hodge, MD, Eastern Maine Medical Center

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

December 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

January 3, 2014

First Submitted That Met QC Criteria

January 3, 2014

First Posted (ESTIMATE)

January 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-1-M-239

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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