Clinical trial NCT02280187: InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study
Official title: InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Fusion
Keywords: InductOs
rhBMP-2
Retrospective
France
Fusion
real world use
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: The Primary Diagnostic Indication for InductOs Use
timeFrame: Baseline
measure: Spine Levels Treated
timeFrame: During surgery
measure: Primary Surgical Approaches Used for Implantation of InductOs
timeFrame: During surgery
measure: The Interbody Device Brand/Generic Names Used With InductOs
timeFrame: during surgery
measure: Placement of the Matrix Wetted With InductOs
timeFrame: During surgery
measure: Supplemental Fixation
timeFrame: During surgery
measure: Instrumentations Used for Stabilization
timeFrame: during surgery
Secondary outcomes:
measure: The Number of Adverse Events of Interest
timeFrame: 12 months
measure: AEI Categorisation
timeFrame: 12 months
measure: The Number of Subjects Having Secondary Spine Surgical Intervention
timeFrame: 12 months
measure: The Number of Unplanned Secondary Spine Interventions in Subgroups
timeFrame: 12 months
measure: Fusion Status at the Last Assessment Performed by 12 Months
timeFrame: 12 months
measure: Fusion Rates in Subgroups
timeFrame: 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux- Centre Universitaire Pellegrin
city: Lyon
country: France
facility: Centre Orthopedique Santy
city: Marseille
country: France
facility: Hopital De La Timone Adultes
city: Marseille
country: France
facility: Hopital Prive Clairval
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: Centre Hospitalier Universitaire Nice - Hôpital Pasteur
city: Saint-Jean
country: France
facility: Nouvelle Clinique De L'Union
city: Saint-Priest en Jarez
country: France
facility: Clinique Du Parc à Saint -Priest en Jarez
city: Strasbourg
country: France
facility: Hopital Civil
city: Toulouse
country: France
facility: Clinique Medipole Garonne
Study officials:
affiliation: Nantes University Hospital
name: Norbert Passuti, Pr
role: PRINCIPAL_INVESTIGATOR
References: