Recruiting

ICONACY I-Hip

Sponsor:

Iconacy Orthopedic Implants, LLC.

Code:

NCT02131389

Conditions

Degenerative Joint Disease

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Iconacy Hip System

Study Details

Brief summary:

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

Conditions

Degenerative Joint Disease

Study ID

NCT02131389

Start date

Apr, 2014

Status verified date

May, 2014

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Iconacy Hip System

Iconacy hip system prosthesis components

Interventions

Iconacy Hip System

Primary outcome measure

  • Radiographic Success as a Measure of Radiolucency and Component Migration [ Time Frame: 2 years ]
  • Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered) [ Time Frame: 2 years ]
  • Patient satisfaction clinical assessment utilizing questionnaire [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Donald L Pomeroy, MD

502-364-9883arthroplastyfoundation@gmail.com

Jan Empson, RN

502-364-0902empsonja@aol.com

Locations

Baptist Health Louisville

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Jan Empson, RN

502-364-0902empsonja@aol.com

Principal Investigator:

Donald L Pomeroy, MD

Sts. Mary & Elizabeth Hospital - KentuckyOne Health

Recruiting

Louisville, Kentucky, United States, 40215

Contacts

Jan Empson, RN

502-364-0902empsonja@aol.com

Principal Investigator:

Donald L Pomeroy, MD

More Information

Sponsor

Iconacy Orthopedic Implants, LLC.

Last update posted

May 6, 2014

Last verified

May, 2014

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Iconacy Orthopedic Implants, LLC. on 2014-05-06.