NCT02027974WithdrawnNot Applicable
ICONACY Hip Clinical Data Acquisition (13-1-M-239)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Harris Hip Score must be > or = 80 at 2 years
Study Overview
Brief Summary
The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for total hip replacement surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Iconacy Hip System
Active Comparator
Iconacy hip system prosthesis components
Intervention: Iconacy Hip System (Device)
Stryker Accolade Hip System
Active Comparator
Stryker Accolade hip system prosthesis components
Intervention: Stryker Accolade Hip System (Device)
Outcomes
Primary Outcomes
Harris Hip Score must be > or = 80 at 2 years
Time Frame: 2 years
Radiographic success
Time Frame: 2 years
Oxford Hip Score > 40 points at 2 years
Time Frame: 2 years
Secondary Outcomes
- 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)
Investigators
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