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

Completed

Conditions: Spine Fusion

Interventions: Procedure: Spine Fusion

Registration Number: NCT02280187

Lead Sponsor: Medtronic Spinal and Biologics

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 400

Inclusion Criteria

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 Criteria

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spine Fusion with InductOs	Spine Fusion	Patient had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012

Primary Outcome Measures

Name	Time	Method
Instrumentations Used for Stabilization	during surgery	The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.
The Primary Diagnostic Indication for InductOs Use	Baseline	The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.
Spine Levels Treated	During surgery	The number of spine levels from the occiput to S1 is presented.
Primary Surgical Approaches Used for Implantation of InductOs	During surgery	The surgical approaches for implanting InductOs are classified as anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), translateral lumbar interbody fusion (TLIF), lateral lumber interbody fusion (LLIF, including DLIF and XLIF), posterolateral fusion (PLF). The number of spine levels by surgical approaches is presented.
The Interbody Device Brand/Generic Names Used With InductOs	during surgery	The number of spine levels with InductOs is presented by interbody brand/generic names.
Placement of the Matrix Wetted With InductOs	During surgery	The placement of the matrix was classified as posterior lateral or interbody space (Inside the cage, between the cages or outside the cage) or any other placement specified. The number of spine levels is presented by placement of the matrix.
Supplemental Fixation	During surgery	The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization).

Secondary Outcome Measures

Name	Time	Method
The Number of Adverse Events of Interest	12 months	An adverse event was considered an event of interest (AEI) if an adverse event was considered important to follow. These included reactions described in the EU product label, events monitored in the EU Risk Management Plan, events that were considered possible related to the treatment by the investigator, and events that had serious health consequences for patients (e.g. hospitalization).
The Number of Subjects Having Secondary Spine Surgical Intervention	12 months	The number of subjects who had secondary spine surgical intervention at index level treated with InductOs and other level (either never treated or treated without InductOs) through 12 months is reported.
The Number of Unplanned Secondary Spine Interventions in Subgroups	12 months	The number of unplanned secondary spine interventions is reported by subgroups (smoker, non-smoker, diabetics, and non-diabetics).
AEI Categorisation	12 months	The number of AEIs is presented by the categories predefined in the study protocol. The AEI MedDRA coded terms are presented in Section of serious adverse event.
Fusion Status at the Last Assessment Performed by 12 Months	12 months	According to the study protocol, fusion status was determined to be either success or no success based on the images. If fusion failed at 1 level, the fusion was considered to be failed for the patient. The fusion rate at the last assessment is reported.
Fusion Rates in Subgroups	12 months	Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.

Trial Locations

Locations (10): Hopital De La Timone Adultes
🇫🇷
Marseille, France
Nouvelle Clinique De L'Union
🇫🇷
Saint-Jean, France
Hopital Prive Clairval
🇫🇷
Marseille, France
Centre Orthopedique Santy
🇫🇷
Lyon, France
Hopital Civil
🇫🇷
Strasbourg, France
Clinique Medipole Garonne
🇫🇷
Toulouse, France
CHU de Bordeaux- Centre Universitaire Pellegrin
🇫🇷
Bordeaux, France
CHU de Nantes
🇫🇷
Nantes, France
Centre Hospitalier Universitaire Nice - Hôpital Pasteur
🇫🇷
Nice, France
Clinique Du Parc à Saint -Priest en Jarez
🇫🇷
Saint-Priest en Jarez, France