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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Spine Fusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Spine Fusion with InductOs

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

Spine Fusion

Intervention Type PROCEDURE

All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.

Interventions

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Spine Fusion

All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No