Orthopedics
Conditions
Keywords
Orthopedic Surgery
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.
Interventions
None listed
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of device associated and procedure associated adverse events. | up to 20 years |
Secondary
| Measure | Time frame |
|---|---|
| Rates of revision surgeries. | up to 20 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Time to first revision surgery. | up to 20 years | — |
| 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. |
| 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 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 |
Countries
United States
Outcome results
None listed