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

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

Sponsors

Lead Sponsor: Tornier, Inc.

Source Tornier, Inc.
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.

Overall Status Recruiting
Start Date 2019-07-30
Completion Date 2040-01-01
Primary Completion Date 2040-01-01
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Number of device associated and procedure associated adverse events. up to 20 years
Secondary Outcome
Measure Time Frame
Rates of revision surgeries. up to 20 years
Enrollment 5000
Condition
Eligibility

Sampling Method:

Non-Probability Sample

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jean Chaoui, PhD, MSc Principal Investigator Wright Medical Technology
Overall Contact

Last Name: Meredith Schreier

Phone: 952-426-7600

Email: [email protected]

Location
Facility: Status: Contact:
Orthopedic Surgeon | Bradenton, Florida, 34209, United States Recruiting Study Investigator
Orthopedic Surgeon | Augusta, Georgia, 30909, United States Recruiting Study Investigator
Orthopedic Surgeon | Orland Park, Illinois, 60467, United States Recruiting Study Investigator
Orthopedic Surgeon | Indianapolis, Indiana, 46260, United States Recruiting Study Investigator
Orthopedic Surgeon | Peabody, Massachusetts, 01960, United States Recruiting Study Investigator
Orthopedic Surgeon | Florham Park, New Jersey, 07932, United States Recruiting Study Investigator
Orthopedic Surgeon | Woodbridge, Virginia, 22191, United States Recruiting Study Investigator
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Acronym SCOR
Study Design Info

Observational Model: Cohort

Time Perspective: Other

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