Degenerative Diseases, Spinal Cord Clinical Trial
Official title:
DegenPRO: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
Verified date | March 2024 |
Source | AO Innovation Translation Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Active, not recruiting |
Enrollment | 908 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | BG-Clinic Bergmannstrost | Halle | |
Italy | Istituto Ortopedico Rizzoli | Bologna | |
United States | Emory University School of Medicine | Atlanta | Georgia |
United States | The Johns Hopkins University | Baltimore | Maryland |
United States | USC Spine Center, Keck Medical Center of USC | Los Angeles | California |
United States | Mount Sinai Hospital | New York | New York |
United States | New York Presbyterian - Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
AO Innovation Translation Center | AO Foundation, AO Spine |
United States, Germany, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Information on postoperative adverse events | 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. | Every standard of care scheduled follow-up visit up to 3 years | |
Other | Duration of postoperative adverse event | 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. | Every standard of care scheduled follow-up visit up to 3 years | |
Primary | 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. |
Every standard of care scheduled follow-up visit up to 3 years | |
Secondary | Neck, Arm, Back, Leg, Thoracic pain Numeric Rating Scale (NRS) | Every standard of care scheduled follow-up visit up to 3 years | ||
Secondary | Neck Disability Index (NDI) | Every standard of care scheduled follow-up visit up to 3 years | ||
Secondary | Oswestry Disability Index (ODI) | Every standard of care scheduled follow-up visit up to 3 years | ||
Secondary | Euroqol EQ-5D-3L | Every standard of care scheduled follow-up visit up to 3 years | ||
Secondary | Short Form (SF)-36 V2 | Every standard of care scheduled follow-up visit up to 3 years | ||
Secondary | Modified Zung Depression Index | Every standard of care scheduled follow-up visit up to 3 years | ||
Secondary | Distress and Risk Assessment Method (DRAM) | Every standard of care scheduled follow-up visit up to 3 years | ||
Secondary | Scoliosis Research Society (SRS)-22 Questionnaire | Every standard of care scheduled follow-up visit up to 3 years | ||
Secondary | Modified Japanese Orthopedic Association Score (mJOA) | Every standard of care scheduled follow-up visit up to 3 years | ||
Secondary | 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. | 6 months after surgery, if this time point is collected as per standard of care | |
Secondary | 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. | 12 months after surgery, if this time point is collected as per standard of care | |
Secondary | 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. | 6 months after surgery, if this time point is collected as per standard of care | |
Secondary | 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. | 12 months after surgery, if this time point is collected as per standard of care | |
Secondary | 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. | 6 months after surgery, if this time point is collected as per standard of care | |
Secondary | 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. | 12 months after surgery, if this time point is collected as per standard of care |
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