InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study (InductOR)

Medtronic

Status: Completed

Conditions: Spine Fusion

Treatments: Procedure: Spine Fusion

Study type: Observational

Funder types: Industry

Identifiers

NCT02280187

2.05.8005

Details and patient eligibility

About

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 of InductOs in Spine fusion in France.

Approximately 10 French centers will enroll 400 patients. The retrospective review of records will focus on patients who have undergone a spinal fusion surgery. Patient should be considered for enrollment if he/she has been treated with InductOs between January 1, 2011 and 31st December 2012.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
2. 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
3. Patient has received the "information and non-objection letter" and reception is confirmed by registered courier
4. Patient is ≥18 years old at the date of the Study Procedure

Exclusion criteria

1. Patient declines participation
2. 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)
3. Patient died since study procedure*
4. Participation in concurrent interventional trial during study participation (from Study Procedure to last study follow-up) which may confound study results

Trial design

400 participants in 1 patient group

Spine Fusion with InductOs

Description:

Patient had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012

Treatment:

Procedure: Spine Fusion