A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders

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.

Study Overview

• Status: Terminated
• Conditions: 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 Type: Observational
• Enrollment (Actual): 908

Contacts and Locations

Study Locations

• Germany
  • Halle, Germany, 06112
    • BG-Clinic Bergmannstrost
• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40136
      • Istituto Ortopedico Rizzoli
• United States
  • California
    • Los Angeles, California, United States
      • USC Spine Center, Keck Medical Center of USC
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University School of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins University
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10032
      • New York Presbyterian - Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a degenerative spine disorder

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Collaborators: AO Foundation, AO Spine
• Investigators: Principal Investigator: Tim Yoon, MD, Principal Coordinating Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimated): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Registry; Spine; Spinal Fusion; Osteobiologics
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurodegenerative Diseases
• Other Study ID Numbers: DegenPRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO