Post-Market Study of the ICONACY Hip System

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02027974

Enrollment

Registered

2014-01-06

Start date

2013-12-31

Completion date

2016-12-31

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Joint Disease

Keywords

Hip, Arthroplasty, Arthroplasties, Prosthesis, Iconacy, Osteoarthritis, Arthritis, THA, THR, DJD

Brief summary

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

Interventions

DEVICEIconacy Hip System

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

DEVICEStryker Accolade Hip System

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026