Degenerative Diseases, Spinal CordNCT02802033
A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
An observational study of Degenerative Diseases, Spinal Cord, run by AO Innovation Translation Center at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Diseases, Spinal Cord
- How many people
- 908 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jan 2016to 31 Jan 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a degenerative spine disorder
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States5 sites
Emory University School of Medicine
Atlanta, Georgia
The Johns Hopkins University
Baltimore, Maryland, 21287
USC Spine Center, Keck Medical Center of USC
Los Angeles, California
Mount Sinai Hospital
New York, New York, 10029
New York Presbyterian - Columbia University Medical Center
New York, New York, 10032
About this study
Official title: DegenPRO: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
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.
Read the 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).
- Conditions
- Degenerative Diseases, Spinal Cord
- Keywords
- Registry, Spine, Osteobiologics, Spinal Fusion
- Medical subject headings
- Neurodegenerative Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every standard of care scheduled follow-up visit up to 3 years
Secondary outcomes (15)
Neck, Arm, Back, Leg, Thoracic pain Numeric Rating Scale (NRS)
Measured: Every standard of care scheduled follow-up visit up to 3 years
Neck Disability Index (NDI)
Measured: Every standard of care scheduled follow-up visit up to 3 years
Oswestry Disability Index (ODI)
Measured: Every standard of care scheduled follow-up visit up to 3 years
Euroqol EQ-5D-3L
Measured: Every standard of care scheduled follow-up visit up to 3 years
Short Form (SF)-36 V2
Measured: Every standard of care scheduled follow-up visit up to 3 years
Modified Zung Depression Index
Measured: Every standard of care scheduled follow-up visit up to 3 years
Distress and Risk Assessment Method (DRAM)
Measured: Every standard of care scheduled follow-up visit up to 3 years
Scoliosis Research Society (SRS)-22 Questionnaire
Measured: Every standard of care scheduled follow-up visit up to 3 years
Modified Japanese Orthopedic Association Score (mJOA)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after surgery, if this time point is collected as per standard of care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJan 2016
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Why it stopped: Discontinued due to a strategic shift in research focus. The steering committee decided to replace the broad registry with multiple targeted prospective cohort studies to ensure higher statistical significance and more focused clinical evidence.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Diseases, Spinal CordStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 908 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Responsible party
- Sponsor
- Investigators
- Tim Yoon, MD, Principal investigator, Principal Coordinating Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802033
- Sponsor's protocol ID
- DegenPRO
- Status last verified
- Apr 2026
- First submitted
- 27 May 2016
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DegenPRO: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
- ClinicalTrials.gov ID
- NCT02802033
- Acronym / sponsor ID
- DegenPRO
- Conditions
- Degenerative Diseases, Spinal Cord
- Keywords
- Registry, Spine, Osteobiologics, Spinal Fusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Discontinued due to a strategic shift in research focus. The steering committee decided to replace the broad registry with multiple targeted prospective cohort studies to ensure higher statistical significance and more focused clinical evidence.
- Enrolment
- 908 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a degenerative spine disorder
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
15 secondary outcomes
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
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)
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)
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
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
Time frame: 12 months after surgery, if this time point is collected as per standard of care
Success of fusion
Time frame: 6 months after surgery, if this time point is collected as per standard of care
Success of fusion
Time frame: 12 months after surgery, if this time point is collected as per standard of care
Results and safety
The study was stopped early (reason given: Discontinued due to a strategic shift in research focus. The steering committee decided to replace the broad registry with multiple targeted prospective cohort studies to ensure higher statistical significance and more focused clinical evidence.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Yoon, MD principal investigator
Principal Coordinating Investigator
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Diseases, Spinal Cord, run by AO Innovation Translation Center at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Discontinued due to a strategic shift in research focus. The steering committee decided to replace the broad registry with multiple targeted prospective cohort studies to ensure higher statistical significance and more focused clinical evidence.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.