Clinical trial NCT02131389: Multi-Site, Post-Market Study of the ICONACY I-Hip System
Official title: Non-Randomized, Multi-Site, Post-Market Study of the ICONACY I-Hip System (Protocol No. PS-1001)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Joint Disease
Keywords: Hip
Arthroplasty
Arthroplasties
Prosthesis
Iconacy
Osteoarthritis
Arthritis
THA
THR
DJD
Lead sponsor: Iconacy Orthopedic Implants, LLC.
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Radiographic Success as a Measure of Radiolucency and Component Migration
timeFrame: 2 years
measure: Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered)
timeFrame: 2 years
measure: Patient satisfaction clinical assessment utilizing questionnaire
timeFrame: 2 years
Secondary outcomes:
measure: Revision of Implant Prosthesis as a Measure of Efficacy
timeFrame: 5 years
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Louisville
country: United States
facility: Sts. Mary & Elizabeth Hospital - KentuckyOne Health
state: Kentucky
Study officials:
affiliation: Pomeroy & Rhoads Orthopaedics, Inc.
name: Donald L Pomeroy, MD
role: PRINCIPAL_INVESTIGATOR
References: