Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-01 @ 8:32 AM
Study NCT ID:
NCT02802033
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2016-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
Sponsor:
AO Innovation Translation Center
Organization:
Study Overview
Official Title:
DegenPRO: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: