Clinical Outcome Measure at Stryker Spine: COMPASS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 5,222
- Locations
- 7
- Primary Endpoint
- S-S-102-C
Study Overview
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).
Detailed Description
Stryker Spine has a broad portfolio of spinal devices used to stabilize the spine. This PMCF study is designed to collect data on the performance and safety of the devices over their lifetime of 24 months post-implantation. Four protocols have been designed to aid in this process, a master and three sub-protocols. The sub-protocols are based on body region and indication:
- S-S-102-A Cervical: Interbody Devices (IBDs), Vertebral Body Replacement Devices (VBRs), Internal Fixation Devices, and Vitoss
- S-S-102-B Thoracolumbar: IBDs, VBRs, Internal Fixation Devices, and Vitoss
- S-S-102-C Adult Spinal Deformities: IBDs, Internal Fixation Devices, and Vitoss Each of the sub-protocols has its own specific performance endpoint and hypothesis, radiographical data assessments, and SAPs. Safety data will be collected throughout the study.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be eligible to participate in the study, the potential subject must meet all inclusion criteria specific to the Stryker system being evaluated, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.
Exclusion Criteria
- •The exclusion criteria are based on the contraindications as presented in the Stryker device cleared IFUs, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.
Outcomes
Primary Outcomes
S-S-102-C
Time Frame: Baseline through 24-months post-op.
Mean change in the subject's Scoliosis Research Society-22 revised (SRS-22r).
S-S-102-A
Time Frame: Baseline through 24-months post-op.
Mean change in the subject's Neck Disability Index (NDI) score.
S-S-102-B
Time Frame: Baseline through 24-months post-op.
Mean change in the subject's Oswestry Disability Index (ODI) score.
Secondary Outcomes
- 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.)