A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders

NCT02802033 | Terminated

• 1 other identifier: DegenPRO
• Study Type: observational
• Target: 908
• Locations: 3 countries
• Sites: 7

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.

Conditions

Degenerative Diseases, Spinal Cord

Keywords

Registry; Spine; Osteobiologics; Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Other Outcomes (2)

• Information on postoperative adverse events

  Every standard of care scheduled follow-up visit up to 3 years

• Duration of postoperative adverse event

  Every standard of care scheduled follow-up visit up to 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a degenerative spine disorder

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• AO Innovation Translation Center: lead
• AO Foundation, AO Spine: collaborator

Study Sites (7)

USC Spine Center, Keck Medical Center of USC

Los Angeles, California, United States

Location

Emory University School of Medicine

Atlanta, Georgia, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

New York Presbyterian - Columbia University Medical Center

New York, New York, 10032, United States

Location

BG-Clinic Bergmannstrost

Halle, 06112, Germany

Location

Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Tim Yoon, MD

  Principal Coordinating Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 16, 2016
• Study Start: January 1, 2016
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); DE (1); IT (1)