Clinical Outcome Measure at Stryker Spine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal Fusion, Spinal Fusion, Spinal Deformities Correction.
- Who it may be relevant to
- Registry conditions: Degenerative Disc Disease, Degenerative Scoliosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Outcome Measure at Stryker Spine: COMPASS
Overview
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.
Interventions
- Device Spinal Fusion
Cervical Spinal Fusion - Device Spinal Fusion
Thoracic / Lumbar Spinal Fusion - Device Spinal Deformities Correction
Spinal Deformities Correction
Primary outcome measures
- S-S-102-A [Time frame: Baseline through 24-months post-op.]
- S-S-102-B [Time frame: Baseline through 24-months post-op.]
- S-S-102-C [Time frame: Baseline through 24-months post-op.]
Secondary outcome measures (3)
- S-S-102-A [Time frame: Surgery through 24-months post-op.]
- S-S-102-B [Time frame: Surgery through 24-months post-op.]
- S-S-102-C [Time frame: Surgery through 24-months post-op.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Mayo Clinic Florida — Jacksonville
- MaineHealth Neurosurgery and Spine — Scarborough
- Michigan Orthopaedic Surgeons — Southfield
- Cleveland Clinc — Cleveland
- Vanderbilt University Medical Center — Nashville
- Texas Spine & Scoliosis — Austin
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT06226272 · S-S-102