Status:
COMPLETED
InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Spine Fusion
Eligibility:
All Genders
18+ years
Brief Summary
It is a phase IV, national, multicenter, observational, retrospective study collecting data from patient medical files in French spinal centers. The aim of the study is to describe the real world use...
Eligibility Criteria
Inclusion
- Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
- Patient as medical records documenting Study Procedure with at least: Age, sex, medical history, primary diagnostic indication, level(s) treated, procedure(s) type, interbody device's information if used
- Patient has received the "information and non-objection letter" and reception is confirmed by registered courier
- Patient is ≥18 years old at the date of the Study Procedure
Exclusion
- Patient declines participation
- Vulnerable patients, unable to understand the non-objection letter or unable to exercise free decision to refuse to participate to the study (at investigator's discretion)
- Patient died since study procedure\*
- Participation in concurrent interventional trial during study participation (from Study Procedure to last study follow-up) which may confound study results
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02280187
Start Date
October 1 2014
End Date
October 1 2015
Last Update
February 6 2017
Active Locations (10)
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1
CHU de Bordeaux- Centre Universitaire Pellegrin
Bordeaux, France
2
Centre Orthopedique Santy
Lyon, France
3
Hopital De La Timone Adultes
Marseille, France
4
Hopital Prive Clairval
Marseille, France