Clinical Trials Logo

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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02802033
Study type Observational [Patient Registry]
Source AO Innovation Translation Center
Contact
Status Active, not recruiting
Phase
Start date January 2016
Completion date December 2026

See also
  Status Clinical Trial Phase
Completed NCT05360199 - Are Postoperative Patient PROMS Influenced by Recall of Preoperative Scores? N/A
Suspended NCT04589572 - Extreme Lateral Interbody FusionFUSION (XLIF) Versus Posterior Lumbar Interbody Fusion (PLIF) N/A