Post-Market Study of the ICONACY Hip System

Not Applicable

Withdrawn

• Conditions: Degenerative Joint Disease
• Interventions: Device: Iconacy Hip System; Device: Stryker Accolade Hip System

• Registration Number: NCT02027974
• Lead Sponsor: Iconacy Orthopedic Implants, LLC.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-03
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-13
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iconacy Hip System	Iconacy Hip System	Iconacy hip system prosthesis components
Stryker Accolade Hip System	Stryker Accolade Hip System	Stryker Accolade hip system prosthesis components

Primary Outcome Measures

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

Secondary Outcome Measures

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