Collecting Orthopedic Safety and Performance Data Using Surgeons Clinical Outcomes Registry (SCOR) (SCOR)

June 23, 2022 updated by: Stryker Trauma GmbH
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 Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

723

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34209
        • Orthopedic Surgeon
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Orthopedic Surgeon
    • Illinois
      • Orland Park, Illinois, United States, 60467
        • Orthopedic Surgeon
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Orthopedic Surgeon
    • Massachusetts
      • Peabody, Massachusetts, United States, 01960
        • Orthopedic Surgeon
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Orthopedic Surgeon
    • Virginia
      • Woodbridge, Virginia, United States, 22191
        • Orthopedic Surgeon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from United States, Europe, Canada and Australia.

Description

Inclusion criteria:

• Patients 18 years of age or older that have or will be receiving a Wright Medical product

Exclusion criteria:

• 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of device associated and procedure associated adverse events.
Time Frame: up to 20 years
up to 20 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rates of revision surgeries.
Time Frame: up to 20 years
up to 20 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first revision surgery.
Time Frame: up to 20 years
up to 20 years
Change from baseline to previous visit in ASES scores
Time Frame: Standard of care follow up visits up to 20 years
ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
Standard of care follow up visits up to 20 years
Change from baseline to previous visit in Constant Murley scores
Time Frame: Standard of care follow up visits up to 20 years
Combination of physician-completed and patient-reported portions to assess functional state of shoulder including range of motion; total score reported out of 100 measuring where lower scores indicate less function of the evaluated shoulder
Standard of care follow up visits up to 20 years
Change from baseline to previous visit in SANE scores
Time Frame: Standard of care follow up visits up to 20 years
SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%
Standard of care follow up visits up to 20 years
Change from baseline to previous visit in Patient Satisfaction scores
Time Frame: Standard of care follow up visits up to 20 years
Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction
Standard of care follow up visits up to 20 years
Change from baseline to previous visit in SST scores
Time Frame: Standard of care follow up visits up to 20 years
SST = Simple Shoulder Test; 12 Y/N questions assessing patient's perspective of shoulder function scored out of 100% where lower scores indicate less function
Standard of care follow up visits up to 20 years
Change from baseline to previous visit in WOOS scores
Time Frame: Standard of care follow up visits up to 20 years
WOOS = Western Ontario Osteoarthritis of the Shoulder; 19 items measuring quality of life specific to patient's shoulder. Each item is out of 100, where a total score is summed where the worst possible score is 1900, the aggregate score is subtracted from 1900 and divided by 19 to provide the score in a % out of 100% with 100% being worst score.
Standard of care follow up visits up to 20 years
Change from baseline to previous visit in PROMIS scores
Time Frame: Standard of care follow up visits up to 20 years
PROMIS Global Health = Patient-Reported Outcomes Measurement Information System - Global Health questionnaire; The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. Higher scores indicate a healthier patient with a total score of 50.
Standard of care follow up visits up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Trauma GmbH

Investigators

  • Principal Investigator: Jean Chaoui, PhD, MSc, Stryker Trauma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2019

Primary Completion (Actual)

January 21, 2022

Study Completion (Actual)

January 21, 2022

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (Actual)

July 25, 2019

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19F-W-SCOR-RM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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