Post-Market Study of the ICONACY Hip System

Degenerative Joint Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02027974
• Other study ID #: 13-1-M-239
• Status: Withdrawn
• Phase: N/A
• First received: January 3, 2014
• Last updated: May 12, 2014
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2014
• Source: Iconacy Orthopedic Implants, LLC.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Device:
• Iconacy Hip System
Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.
• Stryker Accolade Hip System
Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iconacy Orthopedic Implants, LLC.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic success		2 years	No
Primary	Harris Hip Score must be > or = 80 at 2 years		2 years	No
Primary	Oxford Hip Score > 40 points at 2 years		2 years	No
Secondary	Patient Satisfaction at 1, 2, and 3 years		1, 2, and 3 years	No
Secondary	Improvement in Harris Hip Score from pre-surgery to 1, 2, and 3 years		1, 2, and 3 years	No
Secondary	Improvements in Oxford Hip Score from pre-survey to 1, 2, and 3 years		1, 2, and 3 years	No