Details regarding the degenerative spine disorders will be collected with a specific focus on the use of osteobiologics in treating degenerative conditions and their impact on fusion, as well as patient-reported outcomes for these conditions.
The registry is designed to be open-ended. However, a statistical evaluation of the content und structure of database and CRFs in order to investigate the feasibility and quality of data collection is planned to take place prior to the registry expansion. Variables applicable to patients with a degenerative spine disorder which will be collected in the registry include: * Patient details * Symptoms * Diagnosis * Imaging assessment * Treatment details Feasibility phase: The statistical evaluation of the feasibility and quality of data collection will be performed after the first 5 sites have each enrolled 12 patients with a degenerative pathology and documented one follow-up visit. During this evaluation, enrolment of further patients can be continued. Based on the findings of this feasibility phase, adjustments to the existing database can be performed before the registry is rolled out on larger scale. Registry expansion: Following the evaluation process of the feasibility phase, the registry will be expanded to allow data entry in more sites globally. Multi-site participation of this registry will be rolled-out in stages, and will be offered to sites with appropriate expertise which are selected based on their potential (interest, resources and expected patient volume).
Study Type
OBSERVATIONAL
Enrollment
908
USC Spine Center, Keck Medical Center of USC
Los Angeles, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Mount Sinai Hospital
New York, New York, United States
Use of Osteobiologics - Within the registry information on the use of osteobiologis (autografts, allografts, BMA/cells, BMP, DBM, matrices/carriers, platelets) are collected
Osteobiologics are classified as autogenous bone graft substitutes, extenders, or enhancers. Types of osteobiologics include demineralized bone matrices (DBM), allografts and allograft formulations, synthetic bone grafts, bone morphogenic proteins, bone marrow aspirate systems, stem cells and platelet-rich plasma systems. The biologics are generally defined as being derived from or replicating natural substances. The osteobiologics are defined as such by possessing one or more of the following properties: osteoinductivity, osteoconductivity, and osteogenicity. Although biologics are classically defined as being derived from or replicating natural substances, a broader definition of an osteobiologic includes synthetic derivatives that may not replicate natural substances, but serve as a bone graft substitute, extender or enhancer. There is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.
Time frame: Every standard of care scheduled follow-up visit up to 3 years
Neck, Arm, Back, Leg, Thoracic pain Numeric Rating Scale (NRS)
Time frame: Every standard of care scheduled follow-up visit up to 3 years
Neck Disability Index (NDI)
Time frame: Every standard of care scheduled follow-up visit up to 3 years
Oswestry Disability Index (ODI)
Time frame: Every standard of care scheduled follow-up visit up to 3 years
Euroqol EQ-5D-3L
Time frame: Every standard of care scheduled follow-up visit up to 3 years
Short Form (SF)-36 V2
Time frame: Every standard of care scheduled follow-up visit up to 3 years
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New York Presbyterian - Columbia University Medical Center
New York, New York, United States
BG-Clinic Bergmannstrost
Halle, Germany
Istituto Ortopedico Rizzoli
Bologna, Bologna, Italy
Modified Zung Depression Index
Time frame: Every standard of care scheduled follow-up visit up to 3 years
Distress and Risk Assessment Method (DRAM)
Time frame: Every standard of care scheduled follow-up visit up to 3 years
Scoliosis Research Society (SRS)-22 Questionnaire
Time frame: Every standard of care scheduled follow-up visit up to 3 years
Modified Japanese Orthopedic Association Score (mJOA)
Time frame: Every standard of care scheduled follow-up visit up to 3 years
Type of fusion that was performed (posterior and/or anterior/interbody fusion)
Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.
Time frame: 6 months after surgery, if this time point is collected as per standard of care
Type of fusion that was performed (posterior and/or anterior/interbody fusion)
Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.
Time frame: 12 months after surgery, if this time point is collected as per standard of care
Fusion: Bridging trabecular bone across the segment, bone graft resorption, implant subsidence/migration, fatigue failure of spinal instrumentation, radioluciencies around screws, instability on flexion/extension views
Radiological source for interpretation (Clinical assessment, radiographs, CT, MRI, bone scan, other) Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.
Time frame: 6 months after surgery, if this time point is collected as per standard of care
Fusion: Bridging trabecular bone across the segment, bone graft resorption, implant subsidence/migration, fatigue failure of spinal instrumentation, radioluciencies around screws, instability on flexion/extension views
Radiological source for interpretation (Clinical assessment, radiographs, CT, MRI, bone scan, other) Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.
Time frame: 12 months after surgery, if this time point is collected as per standard of care
Success of fusion
Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.
Time frame: 6 months after surgery, if this time point is collected as per standard of care
Success of fusion
Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.
Time frame: 12 months after surgery, if this time point is collected as per standard of care