A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders

AO Innovation Translation Center

Status: Active, not recruiting

Conditions: Degenerative Diseases, Spinal Cord

Study type: Observational

Funder types: Other

Identifiers

NCT02802033

DegenPRO

Details and patient eligibility

About

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.

Full 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).

Enrollment: 908 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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