Clinical trial NCT02802033: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
Official title: DegenPRO: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Degenerative Diseases, Spinal Cord
Keywords: Registry
Spine
Osteobiologics
Spinal Fusion
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AO Foundation, AO Spine
First posted: 2016-06-16
Enrollment: 908
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a degenerative spine disorder

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.

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).

Eligibility 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

Primary outcomes:
measure: Use of Osteobiologics - Within the registry information on the use of osteobiologis (autografts, allografts, BMA/cells, BMP, DBM, matrices/carriers, platelets) are collected
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
Secondary outcomes:
measure: Neck, Arm, Back, Leg, Thoracic pain Numeric Rating Scale (NRS)
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
measure: Neck Disability Index (NDI)
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
measure: Oswestry Disability Index (ODI)
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
measure: Euroqol EQ-5D-3L
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
measure: Short Form (SF)-36 V2
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
measure: Modified Zung Depression Index
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
measure: Distress and Risk Assessment Method (DRAM)
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
measure: Scoliosis Research Society (SRS)-22 Questionnaire
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
measure: Modified Japanese Orthopedic Association Score (mJOA)
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
measure: Type of fusion that was performed (posterior and/or anterior/interbody fusion)
timeFrame: 6 months after surgery, if this time point is collected as per standard of care
measure: Type of fusion that was performed (posterior and/or anterior/interbody fusion)
timeFrame: 12 months after surgery, if this time point is collected as per standard of care
measure: 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
timeFrame: 6 months after surgery, if this time point is collected as per standard of care
measure: 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
timeFrame: 12 months after surgery, if this time point is collected as per standard of care
measure: Success of fusion
timeFrame: 6 months after surgery, if this time point is collected as per standard of care
measure: Success of fusion
timeFrame: 12 months after surgery, if this time point is collected as per standard of care
Other outcomes:
measure: Information on postoperative adverse events
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
measure: Duration of postoperative adverse event
timeFrame: Every standard of care scheduled follow-up visit up to 3 years
Locations:
city: Los Angeles
country: United States
facility: USC Spine Center, Keck Medical Center of USC
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian - Columbia University Medical Center
state: New York
city: Halle
country: Germany
facility: BG-Clinic Bergmannstrost
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Principal Coordinating Investigator
name: Tim Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References: