Arthroplasty, Replacement, HipiCORENCT02422667
iCORE: Collaborative Orthopedics Outcomes Registry
An observational study of Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by SCRI Development Innovations, LLC at 1 site in United States.
Trial summary
The goal of this registry is to review the data collected and research ways to improve patient safety, quality of care, and medical decision-making, reduce medical spending, and help advance orthopedic science and bioengineering. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- What is being tested?
- Patient Registry
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2017
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years and older who undergo hip and/or knee arthroplasty. Patient must have the ability to understand the nature of the registry and give written informed consent.
Who may be able to join
- 18 years or older
- Patients requested to be seen by an orthopedic surgeon participating in the iCORE Registry.
- Patient must have the ability to understand the nature of the registry and give written informed consent.
Who cannot join
- There are no exclusion criteria for this Outcomes Registry.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this registry is to review the data collected and research ways to improve patient safety, quality of care, and medical decision-making, reduce medical spending, and help advance orthopedic science and bioengineering.
- Being tested
- Patient Registry
- Keywords
- Orthopedics, Outcome Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient RegistryOther
Orthopedic Data Registry
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Improvement
Measured: 10 years
Treatment Patterns
Measured: 5 years
Healthcare Utilization
Measured: 5 years
Secondary outcomes (2)
Humanistic Outcomes
Measured: 10 years
Economic Outcomes
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Study cancelled - no results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David K DeBoer, MD, Principal investigator, SJRI/SCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422667
- Sponsor's protocol ID
- SCRI HEOR_03
- Acronym
- iCORE
- Status last verified
- Aug 2020
- First submitted
- 14 Apr 2015
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCORE: Collaborative Orthopedics Outcomes Registry
- ClinicalTrials.gov ID
- NCT02422667
- Acronym / sponsor ID
- iCORE / SCRI HEOR_03
- Keywords
- Orthopedics, Outcome Assessment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study cancelled - no results
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 21 Apr 2015 (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 goal of this registry is to review the data collected and research ways to improve patient safety, quality of care, and medical decision-making, reduce medical spending, and help advance orthopedic science and bioengineering.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years and older who undergo hip and/or knee arthroplasty. Patient must have the ability to understand the nature of the registry and give written informed consent.
Key inclusion criteria (3 listed)
- 18 years or older
- Patients requested to be seen by an orthopedic surgeon participating in the iCORE Registry.
- Patient must have the ability to understand the nature of the registry and give written informed consent.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this Outcomes Registry.
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 |
|---|---|---|
| Patient RegistryOrthopedic Data Registry | Other | – |
Primary outcome
Quality Improvement
Time frame: 10 years
Treatment Patterns
Time frame: 5 years
Healthcare Utilization
Time frame: 5 years
2 secondary outcomes
Humanistic Outcomes
Time frame: 10 years
Economic Outcomes
Time frame: 10 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 5 Dec 2023.
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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.
David K DeBoer, MD principal investigator
SJRI/SCRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by SCRI Development Innovations, LLC at 1 site 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 3 inclusion and 1 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Quality Improvement (time frame: 10 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 5 Dec 2023.