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

I

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

Iconacy Hip System
Other group
Description:
Iconacy hip system prosthesis components
Treatment:
Device: Iconacy Hip System

Trial contacts and locations

2

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Central trial contact

Jan Empson, RN; Donald L Pomeroy, MD

Data sourced from clinicaltrials.gov

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