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

Orthopedics Clinical Trial

— SCOR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04032444
• Other study ID #: 19F-W-SCOR-RM
• Status: Terminated
• Start date: July 30, 2019
• Est. completion date: January 21, 2022

Study information

• Verified date: June 2022
• Source: Stryker Trauma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 development for product design, software improvements, and development of artificial intelligence learning and tools.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 723
• Est. completion date: January 21, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Orthopedics

Locations

Country	Name	City	State
United States	Orthopedic Surgeon	Augusta	Georgia
United States	Orthopedic Surgeon	Bradenton	Florida
United States	Orthopedic Surgeon	Florham Park	New Jersey
United States	Orthopedic Surgeon	Indianapolis	Indiana
United States	Orthopedic Surgeon	Orland Park	Illinois
United States	Orthopedic Surgeon	Peabody	Massachusetts
United States	Orthopedic Surgeon	Woodbridge	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to first revision surgery.		up to 20 years
Other	Change from baseline to previous visit in ASES scores	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
Other	Change from baseline to previous visit in Constant Murley scores	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
Other	Change from baseline to previous visit in SANE scores	SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%	Standard of care follow up visits up to 20 years
Other	Change from baseline to previous visit in Patient Satisfaction scores	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
Other	Change from baseline to previous visit in SST scores	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
Other	Change from baseline to previous visit in WOOS scores	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
Other	Change from baseline to previous visit in PROMIS scores	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
Primary	Number of device associated and procedure associated adverse events.		up to 20 years
Secondary	Rates of revision surgeries.		up to 20 years