Degenerative Joint DiseaseNCT02131389
Multi-Site, Post-Market Study of the ICONACY I-Hip System
A study testing Iconacy Hip System in people with Degenerative Joint Disease, run by Iconacy Orthopedic Implants, LLC. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total hip replacement surgery. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Degenerative Joint Disease
- What is being tested?
- Iconacy Hip System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Baptist Health Louisville
Louisville, Kentucky, 40207
Jan Empson, RN, 502-364-0902 ext. 113, empsonja@aol.com
Donald L Pomeroy, MD
- Recruiting
Sts. Mary & Elizabeth Hospital - KentuckyOne Health
Louisville, Kentucky, 40215
Jan Empson, RN, 502-364-0902 ext. 113, empsonja@aol.com
Donald L Pomeroy, MD
About this study
Official title: Non-Randomized, Multi-Site, Post-Market Study of the ICONACY I-Hip System (Protocol No. PS-1001)
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
- Being tested
- Iconacy Hip System
- Keywords
- Hip, Arthroplasty, Arthroplasties, Prosthesis, Iconacy, Osteoarthritis, Arthritis, THA, THR, DJD
- Medical subject headings
- Joint Diseases, Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iconacy Hip SystemDevice
Also called Iconacy I-Hip, I-Hip, iHip
| Study group | Role | What they receive |
|---|---|---|
| Iconacy Hip System | Other | Iconacy hip system prosthesis components Receives: Device: Iconacy Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered)
Measured: 2 years
Patient satisfaction clinical assessment utilizing questionnaire
Clinical assessment of patient satisfaction will be made by utilizing a Patient Satisfaction (PS) questionnaire.
Measured: 2 years
Secondary outcomes (1)
Revision of Implant Prosthesis as a Measure of Efficacy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iconacy Orthopedic Implants, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald L Pomeroy, MD, Principal investigator, Pomeroy & Rhoads Orthopaedics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131389
- Sponsor's protocol ID
- PS-1001
- Status last verified
- May 2014
- First submitted
- 28 Apr 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Randomized, Multi-Site, Post-Market Study of the ICONACY I-Hip System (Protocol No. PS-1001)
- ClinicalTrials.gov ID
- NCT02131389
- Acronym / sponsor ID
- PS-1001
- Conditions
- Degenerative Joint Disease
- Keywords
- Hip, Arthroplasty, Arthroplasties, Prosthesis, Iconacy, Osteoarthritis, Arthritis, THA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Iconacy Orthopedic Implants, LLC.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total hip replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iconacy Hip System | Other | Device: Iconacy Hip SystemIconacy hip system prosthesis components |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iconacy Hip SystemAlso: Iconacy I-Hip, I-Hip, iHip | Device | Iconacy Hip System |
Primary outcome
Radiographic Success as a Measure of Radiolucency and Component Migration
Time frame: 2 years
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: 1. there is a complete radiolucent line> 3mm wide at the bone/cement interface or 2. there is a >5 degree migration (shift) of the component or 3. there is a >5 mm migration (shift) of the component.
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
Clinical assessment of patient satisfaction will be made by utilizing a Patient Satisfaction (PS) questionnaire.
1 secondary outcome
Revision of Implant Prosthesis as a Measure of Efficacy
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald L Pomeroy, MD principal investigator
Pomeroy & Rhoads Orthopaedics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iconacy Hip System in people with Degenerative Joint Disease, run by Iconacy Orthopedic Implants, LLC. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donald L Pomeroy, MD (502-364-9883, arthroplastyfoundation@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Success as a Measure of Radiolucency and Component Migration (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.