Multi-Site, Post-Market Study of the ICONACY I-Hip System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total hip replacement surgery.

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Detailed Description

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Conditions

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Degenerative Joint Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iconacy Hip System

Iconacy hip system prosthesis components

Group Type OTHER

Iconacy Hip System

Intervention Type DEVICE

Interventions

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Iconacy Hip System

Intervention Type DEVICE

Other Intervention Names

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Iconacy I-Hip I-Hip iHip

Eligibility Criteria

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Inclusion Criteria

* A candidate for primary hip replacement on this operative hip.
* Is 30 to 80 years of age.
* Has hip joint disease related to one or more of the following:

* Degenerative joint disease, (including osteoarthritis or post-traumatic arthritis)
* Avascular Necrosis (AVN).
* Will be available for evaluation for the duration of the study.
* Is able and willing to speak and read English, read and sign the informed consent, fill out the WOMAC and Patient Satisfaction questionnaires, and follow all study procedures.

Exclusion Criteria

* Is younger than 30 years of age or older than 80 years of age.
* Has undergone partial hip replacement or previous ORIF (open reduction internal fixation of femur or acetabulum).
* Has undergone total hip replacement on this hip in the past (no revisions allowed in study).
* Infection, or history of infection, acute or chronic, in the hip joint, or acute or chronic unresolved systemic infection.
* Is currently experiencing radicular pain from the spine down operative leg.
* Has participated in an IDE/IND clinical investigation with an investigational product in the last three months, or is involved in any personal injury litigation, medical-legal or worker's compensation claim.
* Is a known drug or alcohol abuser or has a psychological disorder that could affect the ability to complete patient reported questionnaires.
* Has been diagnosed with fibromyalgia or has a significant neurological or musculoskeletal disorder or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
* Has been diagnosed with Paget's disease or Congenital hip deformity (dysplasia and/or dislocation).
* Is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.)
* Is Obese: (Defined for this study as having a BMI\>45).
* Has insufficient bone quality.
* Has loss of ligamentous structures.
* Has materials sensitivity.
* Is currently a prisoner.
* Is pregnant or lactating.
* Has a contralateral amputation.
* Has a medical condition with less than 2 years of life expectancy.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No