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A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02802033
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
AOSpine International
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Study Description
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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.

Condition or disease
Degenerative Diseases, Spinal Cord

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).

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: DegenPRO: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Use of Osteobiologics - Within the registry information on the use of osteobiologis (autografts, allografts, BMA/cells, BMP, DBM, matrices/carriers, platelets) are collected [ Time Frame: 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 :
  1. Neck, Arm, Back, Leg, Thoracic pain Numeric Rating Scale (NRS) [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
  2. Neck Disability Index (NDI) [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
  3. Oswestry Disability Index (ODI) [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
  4. Euroqol EQ-5D-3L [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
  5. Short Form (SF)-36 V2 [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
  6. Modified Zung Depression Index [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
  7. Distress and Risk Assessment Method (DRAM) [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
  8. Scoliosis Research Society (SRS)-22 Questionnaire [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
  9. Modified Japanese Orthopedic Association Score (mJOA) [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
  10. Type of fusion that was performed (posterior and/or anterior/interbody fusion) [ Time Frame: 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.

  11. Type of fusion that was performed (posterior and/or anterior/interbody fusion) [ Time Frame: 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.

  12. 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 [ Time Frame: 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.

  13. 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 [ Time Frame: 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.

  14. Success of fusion [ Time Frame: 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.

  15. Success of fusion [ Time Frame: 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.


Other Outcome Measures:
  1. Information on postoperative adverse events [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
    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.

  2. Duration of postoperative adverse event [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a degenerative spine disorder
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802033


Contacts
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Contact: Katrin Simioni, PhD +41 81 414 25 09 katrin.simioni@aofoundation.org
Contact: Nicole Neutz +41 44 200 24 78 nicole.neutz@aofoundation.org

Locations
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Germany
BG-Clinic Bergmannstrost Recruiting
Halle, Germany, 06112
Contact: Hans-Jörg Meisel, Prof       meisel@bergmannstrost.com   
Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOSpine International
Investigators
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Principal Investigator: Tim Yoon, MD Principal Coordinating Investigator
More Information
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Additional Information:

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Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT02802033    
Other Study ID Numbers: DegenPRO
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AO Clinical Investigation and Documentation:
Registry
Spine
Osteobiologics
Spinal Fusion
Additional relevant MeSH terms:
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Spinal Diseases
Neurodegenerative Diseases
Bone Diseases
Musculoskeletal Diseases
Nervous System Diseases