NCT04032444

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
723

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

July 30, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

2.5 years

First QC Date

July 16, 2019

Last Update Submit

June 23, 2022

Conditions

Orthopedics

Keywords

Orthopedic Surgery

Outcome Measures

Primary Outcomes (1)

  • Number of device associated and procedure associated adverse events.

    up to 20 years

Secondary Outcomes (1)

  • Rates of revision surgeries.

    up to 20 years

Other Outcomes (8)

  • 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

  • Change from baseline to previous visit in Constant Murley scores

    Standard of care follow up visits up to 20 years

  • +5 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from United States, Europe, Canada and Australia.

You may qualify if:

  • Patients 18 years of age or older that have or will be receiving a Wright Medical product

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Orthopedic Surgeon

Bradenton, Florida, 34209, United States

Location

Orthopedic Surgeon

Augusta, Georgia, 30909, United States

Location

Orthopedic Surgeon

Orland Park, Illinois, 60467, United States

Location

Orthopedic Surgeon

Indianapolis, Indiana, 46260, United States

Location

Orthopedic Surgeon

Peabody, Massachusetts, 01960, United States

Location

Orthopedic Surgeon

Florham Park, New Jersey, 07932, United States

Location

Orthopedic Surgeon

Woodbridge, Virginia, 22191, United States

Location

Study Officials

  • Jean Chaoui, PhD, MSc

    Stryker Trauma and Extremities

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
20 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 25, 2019

Study Start

July 30, 2019

Primary Completion

January 21, 2022

Study Completion

January 21, 2022

Last Updated

June 29, 2022

Record last verified: 2022-06

Locations

US(7)