Degenerative Joint DiseaseNCT02027974
Post-Market Study of the ICONACY Hip System
A study testing Iconacy Hip System and Stryker Accolade Hip System in people with Degenerative Joint Disease, run by Iconacy Orthopedic Implants, LLC..
Trial summary
The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for total hip replacement surgery. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Degenerative Joint Disease
- What is being tested?
- Iconacy Hip System and Stryker Accolade Hip System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This must be a primary hip replacement on this hip
- Patient is 30 years of age or older
- Have hip joint disease related to one or more of the following: degenerative joint disease, including osteoarthritis or traumatic arthritis
- Patient is likely to be available for evaluation for the duration of the study
- Able and willing to sign the informed consent and follow study procedures
Who cannot join
- Is younger than 30 years of age
- If there has been a total hip replacement on this hip in the past (no revisions allowed in study)
- Infection, or history of infection, acute or chronic, local or systemic
- Alcoholism or other addictions
- Muscular, neurological or vascular deficiencies which compromise the affected extremity
- Obesity(BMI>45)
Show all 14Show fewer
- Insufficient bone quality
- Loss of ligamentous structures
- High levels of physical activity
- Materials sensitivity
- Prisoner
- Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
- Patient is pregnant
- Is not able to read English language
About this study
Official title: ICONACY Hip Clinical Data Acquisition (13-1-M-239)
The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for total hip replacement surgery.
- Conditions
- Degenerative Joint Disease
- Being tested
- Iconacy Hip System, Stryker Accolade 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
Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.
Stryker Accolade Hip SystemDevice
Also called Accolade
Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.
| Study group | Role | What they receive |
|---|---|---|
| Iconacy Hip System | Active comparator | Iconacy hip system prosthesis components Receives: Device: Iconacy Hip System |
| Stryker Accolade Hip System | Active comparator | Stryker Accolade hip system prosthesis components Receives: Device: Stryker Accolade Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic success
Measured: 2 years
Harris Hip Score must be > or = 80 at 2 years
Measured: 2 years
Oxford Hip Score > 40 points at 2 years
Measured: 2 years
Secondary outcomes (3)
Patient Satisfaction at 1, 2, and 3 years
Measured: 1, 2, and 3 years
Improvement in Harris Hip Score from pre-surgery to 1, 2, and 3 years
Measured: 1, 2, and 3 years
Improvements in Oxford Hip Score from pre-survey to 1, 2, and 3 years
Measured: 1, 2, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iconacy Orthopedic Implants, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William A Hodge, MD, Principal investigator, Eastern Maine Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027974
- Sponsor's protocol ID
- 13-1-M-239
- Status last verified
- May 2014
- First submitted
- 3 Jan 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICONACY Hip Clinical Data Acquisition (13-1-M-239)
- ClinicalTrials.gov ID
- NCT02027974
- Acronym / sponsor ID
- 13-1-M-239
- Conditions
- Degenerative Joint Disease
- Keywords
- Hip, Arthroplasty, Arthroplasties, Prosthesis, Iconacy, Osteoarthritis, Arthritis, THA
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Iconacy Orthopedic Implants, LLC.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Jan 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 Iconacy Hip System for total hip replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iconacy Hip System | Active comparator | Device: Iconacy Hip SystemIconacy hip system prosthesis components |
| Stryker Accolade Hip System | Active comparator | Device: Stryker Accolade Hip SystemStryker Accolade hip system prosthesis components |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- This must be a primary hip replacement on this hip
- Patient is 30 years of age or older
- Have hip joint disease related to one or more of the following: degenerative joint disease, including osteoarthritis or traumatic arthritis
- Patient is likely to be available for evaluation for the duration of the study
- Able and willing to sign the informed consent and follow study procedures
Key exclusion criteria (14 listed)
- Is younger than 30 years of age
- If there has been a total hip replacement on this hip in the past (no revisions allowed in study)
- Infection, or history of infection, acute or chronic, local or systemic
- Alcoholism or other addictions
- Muscular, neurological or vascular deficiencies which compromise the affected extremity
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, iHipComparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study. | Device | Iconacy Hip System |
| Stryker Accolade Hip SystemAlso: AccoladeComparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study. | Device | Stryker Accolade Hip System |
Primary outcome
Radiographic success
Time frame: 2 years
Harris Hip Score must be > or = 80 at 2 years
Time frame: 2 years
Oxford Hip Score > 40 points at 2 years
Time frame: 2 years
3 secondary outcomes
Patient Satisfaction at 1, 2, and 3 years
Time frame: 1, 2, and 3 years
Improvement in Harris Hip Score from pre-surgery to 1, 2, and 3 years
Time frame: 1, 2, and 3 years
Improvements in Oxford Hip Score from pre-survey to 1, 2, and 3 years
Time frame: 1, 2, and 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
Related trials for Degenerative Joint Disease
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
William A Hodge, MD principal investigator
Eastern Maine Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Iconacy Hip System and Stryker Accolade Hip System in people with Degenerative Joint Disease, run by Iconacy Orthopedic Implants, LLC..
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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic success (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 13 May 2014.