A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders

Degenerative Diseases, Spinal Cord Clinical Trial

Official title:

DegenPRO: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02802033
• Other study ID #: DegenPRO
• Status: Active, not recruiting
• Start date: January 2016
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Degenerative Diseases, Spinal Cord
• Neurodegenerative Diseases
• Spinal Diseases

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AO Innovation Translation Center	AO Foundation, AO Spine

Countries where clinical trial is conducted

United States,  Germany,  Italy, 

Outcome

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