This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.
Study Type
OBSERVATIONAL
Enrollment
5,000
* Interbody fusion devices - intended to help facilitate fusion by providing a platform for bone growth, while maintaining height and decompression. * Supplemental fixation and/or stabilization devices - are intended to stabilize the spine to allow for fusion to occur, maintain current spinal movement, correct deformities or curvature, treat trauma, spinal stenosis, tumor and pseudarthrosis. * Bone graft substitute - is intended to aid in fusion.
Hartford Hospital
Hartford, Connecticut, United States
ACTIVE_NOT_RECRUITINGFlorida Back Institute
Boca Raton, Florida, United States
ACTIVE_NOT_RECRUITINGSpine Institute of South Florida
Delray Beach, Florida, United States
ACTIVE_NOT_RECRUITINGSuburban Orthopaedics
Bartlett, Illinois, United States
TERMINATEDIndiana Spine Group
Carmel, Indiana, United States
WITHDRAWNDK Orthopedics
Crown Point, Indiana, United States
COMPLETEDLindner Center for Research & Education at The Christ Hospit
Cincinnati, Ohio, United States
ACTIVE_NOT_RECRUITINGSTENUM Ortho Fachklinik
Ganderkesee, Germany
WITHDRAWNWirbelsäulenzentrum Fulda | Main | Kinzig
Gelnhausen, Germany
ACTIVE_NOT_RECRUITINGKatholisches Klinikum Koblenz - Montabaur
Koblenz, Germany
WITHDRAWN...and 2 more locations
Intervention Rates
Rates of reoperation and/or revision procedures at index level
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Fusion
Fusion success measures by radiological assessment (x-ray, CT scan, MRI, etc.)
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Radiographic Findings
Change in radiographic findings
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Adverse Events
Number of procedure and device related adverse events
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Disability (Cervical)
Change in Neck Disability Index
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Disability (non-Cervical)
Change in Oswestry Disability Index
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Pain Change
Change in pain as determined by Visual Analogue Scale (VAS)
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Time to Intervention
Time to first reoperation and/or revision procedure at index leve
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
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