Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
5222 participants
OBSERVATIONAL
2024-05-06
2032-01-29
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
Spinal Fusion
Cervical Spinal Fusion
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.
Spinal Fusion
Thoracic / Lumbar Spinal Fusion
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.
Spinal Deformities Correction
Spinal Deformities Correction
Interventions
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Spinal Fusion
Cervical Spinal Fusion
Spinal Fusion
Thoracic / Lumbar Spinal Fusion
Spinal Deformities Correction
Spinal Deformities Correction
Eligibility Criteria
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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.
18 Years
ALL
No
Sponsors
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Stryker Spine
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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S-S-102
Identifier Type: -
Identifier Source: org_study_id
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