Clinical Outcome Measure at Stryker Spine
COMPASS
1 other identifier
observational
5,222
0 countries
N/A
Brief Summary
This is a multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions for Use (IFU).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Longer than P75 for all trials
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
January 4, 2024
CompletedFirst Posted
Study publicly available on registry
January 26, 2024
CompletedStudy Start
First participant enrolled
May 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 29, 2032
April 16, 2024
April 1, 2024
4.7 years
January 4, 2024
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
S-S-102-A
Mean change in the subject's Neck Disability Index (NDI) score.
Baseline through 24-months post-op.
S-S-102-B
Mean change in the subject's Oswestry Disability Index (ODI) score.
Baseline through 24-months post-op.
S-S-102-C
Mean change in the subject's Scoliosis Research Society-22 revised (SRS-22r).
Baseline through 24-months post-op.
Secondary Outcomes (3)
S-S-102-A
Surgery through 24-months post-op.
S-S-102-B
Surgery through 24-months post-op.
S-S-102-C
Surgery through 24-months post-op.
Study Arms (3)
S-S-102-A: Cervical Sub-Protocol
The study population includes subjects who are surgically treated with a Stryker device for a cervical condition per the specific device cleared IFUs and Surgical Technique Guides (STGs), by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points.
S-S-102-B: Thoracolumbar Sub-Protocol
The study population includes subjects who are surgically treated with a Stryker device for a thoracic/lumbar condition per the specific device cleared IFUs and STGs, by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points.
S-S-102-C: Adult Spinal Deformities
The study population includes subjects who are surgically treated with a Stryker device for a spinal deformity condition per the specific device cleared IFUs and STGs, by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points.
Interventions
Eligibility Criteria
The study population includes subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared IFUs and Surgical Technique Guides (STGs) by a participating investigator and are willing to complete the following patient-reported outcome measures (PROMs) at the study-specific time points.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stryker Spinelead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2024
First Posted
January 26, 2024
Study Start
May 6, 2024
Primary Completion (Estimated)
January 29, 2029
Study Completion (Estimated)
January 29, 2032
Last Updated
April 16, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share