Degenerative Diseases, Spinal Cord
Conditions
Keywords
Registry, Spine, Osteobiologics, Spinal Fusion
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
AO Innovation Translation Center
AO Foundation, AO Spine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient aged 18 years or older * Patient diagnosed with a degenerative spine disorder who receives treatment for the degenerative spine disorder * Patient capable of understanding the content of the patient information / Informed Consent Form * Patient willing and able to participate in the registry * Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Osteobiologics - Within the registry information on the use of osteobiologis (autografts, allografts, BMA/cells, BMP, DBM, matrices/carriers, platelets) are collected | Every standard of care scheduled follow-up visit up to 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck, Arm, Back, Leg, Thoracic pain Numeric Rating Scale (NRS) | Every standard of care scheduled follow-up visit up to 3 years | — |
| Neck Disability Index (NDI) | Every standard of care scheduled follow-up visit up to 3 years | — |
| Oswestry Disability Index (ODI) | Every standard of care scheduled follow-up visit up to 3 years | — |
| Euroqol EQ-5D-3L | Every standard of care scheduled follow-up visit up to 3 years | — |
| Short Form (SF)-36 V2 | Every standard of care scheduled follow-up visit up to 3 years | — |
| Modified Zung Depression Index | Every standard of care scheduled follow-up visit up to 3 years | — |
| Distress and Risk Assessment Method (DRAM) | Every standard of care scheduled follow-up visit up to 3 years | — |
| Scoliosis Research Society (SRS)-22 Questionnaire | Every standard of care scheduled follow-up visit up to 3 years | — |
| Modified Japanese Orthopedic Association Score (mJOA) | Every standard of care scheduled follow-up visit up to 3 years | — |
| Type of fusion that was performed (posterior and/or anterior/interbody fusion) | 6 months after surgery, if this time point is collected as per standard of care | 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. |
| 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 | 6 months after surgery, if this time point is collected as per standard of care | 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. |
| Success of fusion | 6 months after surgery, if this time point is collected as per standard of care | 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. |
Countries
Germany, Italy, United States
Contacts
PRINCIPAL_INVESTIGATORTim Yoon, MD
Principal Coordinating Investigator
Outcome results
None listed