Collecting Orthopedic Safety and Performance Data Using Surgeons Clinical Outcomes Registry (SCOR)
Study Details
Study Description
Brief 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 development for product design, software improvements, and development of artificial intelligence learning and tools.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Number of device associated and procedure associated adverse events. [up to 20 years]
Secondary Outcome Measures
- Rates of revision surgeries. [up to 20 years]
Other Outcome Measures
- Time to first revision surgery. [up to 20 years]
- Change from baseline to previous visit in ASES scores [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
- Change from baseline to previous visit in Constant Murley scores [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
- Change from baseline to previous visit in SANE scores [Standard of care follow up visits up to 20 years]
SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%
- Change from baseline to previous visit in Patient Satisfaction scores [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
- Change from baseline to previous visit in SST scores [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
- Change from baseline to previous visit in WOOS scores [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.
- Change from baseline to previous visit in PROMIS scores [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orthopedic Surgeon | Bradenton | Florida | United States | 34209 |
| 2 | Orthopedic Surgeon | Augusta | Georgia | United States | 30909 |
| 3 | Orthopedic Surgeon | Orland Park | Illinois | United States | 60467 |
| 4 | Orthopedic Surgeon | Indianapolis | Indiana | United States | 46260 |
| 5 | Orthopedic Surgeon | Peabody | Massachusetts | United States | 01960 |
| 6 | Orthopedic Surgeon | Florham Park | New Jersey | United States | 07932 |
| 7 | Orthopedic Surgeon | Woodbridge | Virginia | United States | 22191 |
Sponsors and Collaborators
- Stryker Trauma GmbH
Investigators
- Principal Investigator: Jean Chaoui, PhD, MSc, Stryker Trauma GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19F-W-SCOR-RM