Multi-Site, Post-Market Study of the ICONACY I-Hip System | NCT02131389

NCT02131389

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Label	Type	Description	Intervention Names
Iconacy Hip System	Other	Iconacy hip system prosthesis components	Device: Iconacy Hip System

Name	Type	Description	Arm Group Labels	Other Names
Iconacy Hip System	Device		Iconacy Hip System	Iconacy I-Hip I-Hip iHip

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered)		2 years
Patient satisfaction clinical assessment utilizing questionnaire	Clinical assessment of patient satisfaction will be made by utilizing a Patient Satisfaction (PS) questionnaire.	2 years

Measure	Description	Time Frame
Revision of Implant Prosthesis as a Measure of Efficacy		5 years

Eligibility Module

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.

Name	Role	Phone	Extension	Email
Donald L Pomeroy, MD	Contact	502-364-9883		arthroplastyfoundation@gmail.com
Jan Empson, RN	Contact	502-364-0902	113	empsonja@aol.com

ID	Term
D007592	Joint Diseases
D010003	Osteoarthritis
D001168	Arthritis

ID	Term
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases