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

Degenerative Joint Disease Clinical Trial

Official title:

Non-Randomized, Multi-Site, Post-Market Study of the ICONACY I-Hip System (Protocol No. PS-1001)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02131389
• Other study ID #: PS-1001
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: May 2, 2014
• Start date: April 2014
• Est. completion date: December 2019

Study information

• Verified date: May 2014
• Source: Iconacy Orthopedic Implants, LLC.
• Contact: Donald L Pomeroy, MD
• Phone: 502-364-9883
• Email: arthroplastyfoundation[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Device:
• Iconacy Hip System

Locations

Country	Name	City	State
United States	Baptist Health Louisville	Louisville	Kentucky
United States	Sts. Mary & Elizabeth Hospital - KentuckyOne Health	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Iconacy Orthopedic Implants, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Success as a Measure of Radiolucency and Component Migration	A subject will be considered a failure for Overall Radiographic Success if one or more of the below conditions are met: The subject will be considered a RADIOGRAPHIC FAILURE if: there is a complete radiolucent line> 3mm wide at the bone/cement interface or; there is a >5 degree migration (shift) of the component or; there is a >5 mm migration (shift) of the component.	2 years	No
Primary	Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered)		2 years	No
Primary	Patient satisfaction clinical assessment utilizing questionnaire	Clinical assessment of patient satisfaction will be made by utilizing a Patient Satisfaction (PS) questionnaire.	2 years	No
Secondary	Revision of Implant Prosthesis as a Measure of Efficacy		5 years	No