Degenerative Disc Disease, Degenerative Scoliosis
Conditions
Keywords
Device: Cervical or Thoracolumbar Spinal fusion, Device: Adult Spinal Deformities
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.
Interventions
DEVICESpinal Fusion
Cervical Spinal Fusion
DEVICESpinal Deformities Correction
Spinal Deformities Correction
Sponsors
VB Spine, LLC
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| S-S-102-A | Baseline through 24-months post-op. | Mean change in the subject's Neck Disability Index (NDI) score. |
| S-S-102-B | Baseline through 24-months post-op. | Mean change in the subject's Oswestry Disability Index (ODI) score. |
| S-S-102-C | Baseline through 24-months post-op. | Mean change in the subject's Scoliosis Research Society-22 revised (SRS-22r). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| S-S-102-A | Surgery through 24-months post-op. | The incidence of the following safety events: * Serious Adverse Events (AEs) * Device-related AEs * Procedure-related AEs * Operative AEs * Secondary spine surgeries |
| S-S-102-B | Surgery through 24-months post-op. | The incidence of the following safety events: * Serious Adverse Events (AEs) * Device-related AEs * Procedure-related AEs * Operative AEs * Secondary spine surgeries |
| S-S-102-C | Surgery through 24-months post-op. | The incidence of the following safety events: * Serious Adverse Events (AEs) * Device-related AEs * Procedure-related AEs * Operative AEs * Secondary spine surgeries |
Countries
United States
Contacts
CONTACTMary Majer
CONTACTEffa Gyamfi
PRINCIPAL_INVESTIGATORJad G. Khalil, MD
Michigan Orthopaedic Surgeons
Outcome results
None listed