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

Iconacy Orthopedic Implants

Status

Unknown

Conditions

Degenerative Joint Disease

Treatments

Device: Iconacy Hip System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02131389

PS-1001

Details and patient eligibility

About

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

Enrollment

500 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.