A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
- Conditions
- Degenerative Diseases, Spinal Cord
- Registration Number
- NCT02802033
- Lead Sponsor
- AO Innovation Translation Center
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 908
- 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
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Distress and Risk Assessment Method (DRAM) 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 Neck, Arm, Back, Leg, Thoracic pain Numeric Rating Scale (NRS) Every standard of care scheduled follow-up visit up to 3 years 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 12 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.
Euroqol EQ-5D-3L 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 Scoliosis Research Society (SRS)-22 Questionnaire 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 Type of fusion that was performed (posterior and/or anterior/interbody fusion) 12 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.
Neck Disability Index (NDI) 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 Success of fusion 12 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.
Trial Locations
- Locations (7)
The Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
USC Spine Center, Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
New York Presbyterian - Columbia University Medical Center
🇺🇸New York, New York, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
BG-Clinic Bergmannstrost
🇩🇪Halle, Germany
Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy
Mount Sinai Hospital
🇺🇸New York, New York, United States