Clinical trial NCT04032444: Collecting Orthopedic Safety and Performance Data Using Surgeons Clinical Outcomes Registry (SCOR)
Official title: Collecting Orthopedic Safety and Performance Data Using Surgeons Clinical Outcomes Registry (SCOR)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Orthopedics
Keywords: Orthopedic Surgery
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2019-07-25
Enrollment: 723
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from United States, Europe, Canada and Australia.

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.


Eligibility 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

Primary outcomes:
measure: Number of device associated and procedure associated adverse events.
timeFrame: up to 20 years
Secondary outcomes:
measure: Rates of revision surgeries.
timeFrame: up to 20 years
Other outcomes:
measure: Time to first revision surgery.
timeFrame: up to 20 years
measure: Change from baseline to previous visit in ASES scores
timeFrame: Standard of care follow up visits up to 20 years
measure: Change from baseline to previous visit in Constant Murley scores
timeFrame: Standard of care follow up visits up to 20 years
measure: Change from baseline to previous visit in SANE scores
timeFrame: Standard of care follow up visits up to 20 years
measure: Change from baseline to previous visit in Patient Satisfaction scores
timeFrame: Standard of care follow up visits up to 20 years
measure: Change from baseline to previous visit in SST scores
timeFrame: Standard of care follow up visits up to 20 years
measure: Change from baseline to previous visit in WOOS scores
timeFrame: Standard of care follow up visits up to 20 years
measure: Change from baseline to previous visit in PROMIS scores
timeFrame: Standard of care follow up visits up to 20 years
Locations:
city: Bradenton
country: United States
facility: Orthopedic Surgeon
state: Florida
city: Augusta
country: United States
facility: Orthopedic Surgeon
state: Georgia
city: Orland Park
country: United States
facility: Orthopedic Surgeon
state: Illinois
city: Indianapolis
country: United States
facility: Orthopedic Surgeon
state: Indiana
city: Peabody
country: United States
facility: Orthopedic Surgeon
state: Massachusetts
city: Florham Park
country: United States
facility: Orthopedic Surgeon
state: New Jersey
city: Woodbridge
country: United States
facility: Orthopedic Surgeon
state: Virginia
Study officials:
affiliation: Stryker Trauma and Extremities
name: Jean Chaoui, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: