OrthopedicsSCORNCT04032444
Collecting Orthopedic Safety and Performance Data Using Surgeons Clinical Outcomes Registry (SCOR)
An observational study of Orthopedics, run by Stryker Trauma and Extremities at 7 sites in United States.
Trial summary
The Surgeons Clinical Outcomes Registry (SCOR) is a global registry designed to collect safety and performance data on commercially available Wright Medical products. Registry data may be used for publications, education and marketing materials, post-market surveillance, future regulatory submissions, research and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedics
- How many people
- 723 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Jul 2019to 21 Jan 2022
- How long will I take part?
- 20 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 from United States, Europe, Canada and Australia.
Who may be able to join
- Patients 18 years of age or older that have or will be receiving a Wright Medical product
Who cannot join
- Member of a vulnerable population, including minors, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Orthopedic Surgeon
Augusta, Georgia, 30909
Orthopedic Surgeon
Bradenton, Florida, 34209
Orthopedic Surgeon
Florham Park, New Jersey, 07932
Orthopedic Surgeon
Indianapolis, Indiana, 46260
Orthopedic Surgeon
Orland Park, Illinois, 60467
Orthopedic Surgeon
Peabody, Massachusetts, 01960
Orthopedic Surgeon
Woodbridge, Virginia, 22191
About this study
The Surgeons Clinical Outcomes Registry (SCOR) is a global registry designed to collect safety and performance data on commercially available Wright Medical products. Registry data may be used for publications, education and marketing materials, post-market surveillance, future regulatory submissions, research and development for product design, software improvements, and development of artificial intelligence learning and tools.
- Conditions
- Orthopedics
- Keywords
- Orthopedic Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of device associated and procedure associated adverse events.
Measured: up to 20 years
Secondary outcomes (1)
Rates of revision surgeries.
Measured: up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start30 Jul 2019
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Why it stopped: Sponsor terminated. No longer needed to support business need
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthopedicsStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
- 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
- 723 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Chaoui, PhD, MSc, Principal investigator, Stryker Trauma and Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032444
- Sponsor's protocol ID
- 19F-W-SCOR-RM
- Acronym
- SCOR
- Status last verified
- Jun 2022
- First submitted
- 16 Jul 2019
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collecting Orthopedic Safety and Performance Data Using Surgeons Clinical Outcomes Registry (SCOR)
- ClinicalTrials.gov ID
- NCT04032444
- Acronym / sponsor ID
- SCOR / 19F-W-SCOR-RM
- Conditions
- Orthopedics
- Keywords
- Orthopedic Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor terminated. No longer needed to support business need
- Enrolment
- 723 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 25 Jul 2019 (actual)
- 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 Surgeons Clinical Outcomes Registry (SCOR) is a global registry designed to collect safety and performance data on commercially available Wright Medical products. Registry data may be used for publications, education and marketing materials, post-market surveillance, future regulatory submissions, research and development for product design, software improvements, and development of artificial intelligence learning and tools.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from United States, Europe, Canada and Australia.
Key inclusion criteria (1 listed)
- Patients 18 years of age or older that have or will be receiving a Wright Medical product
Key exclusion criteria (1 listed)
- Member of a vulnerable population, including minors, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of device associated and procedure associated adverse events.
Time frame: up to 20 years
1 secondary outcome
Rates of revision surgeries.
Time frame: up to 20 years
Results and safety
The study was stopped early (reason given: Sponsor terminated. No longer needed to support business need). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
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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.
Jean Chaoui, PhD, MSc principal investigator
Stryker Trauma and Extremities
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedics, run by Stryker Trauma and Extremities at 7 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 1 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: stopped early, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was stopped early (reason given: Sponsor terminated. No longer needed to support business need). Results are not available in the source record.
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?
Number of device associated and procedure associated adverse events. (time frame: up to 20 years). 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 29 Jun 2022.