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

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.

Study Overview

• Status: Completed
• Conditions: Spine Fusion
• Intervention / Treatment: Procedure: Spine Fusion

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux- Centre Universitaire Pellegrin
  • Lyon, France
    • Centre Orthopedique Santy
  • Marseille, France
    • Hopital Prive Clairval
  • Marseille, France
    • Hopital de la Timone Adultes
  • Nantes, France
    • CHU de Nantes
  • Nice, France, 06002
    • Centre Hospitalier Universitaire Nice - Hôpital Pasteur
  • Saint-Jean, France
    • Nouvelle Clinique De L'Union
  • Saint-Priest en Jarez, France
    • Clinique Du Parc à Saint -Priest en Jarez
  • Strasbourg, France
    • Hopital Civil
  • Toulouse, France
    • Clinique Médipole Garonne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spine Fusion with InductOs; Patient had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012	Procedure: Spine Fusion; All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Primary Diagnostic Indication for InductOs Use	The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.	Baseline
Spine Levels Treated	The number of spine levels from the occiput to S1 is presented.	During surgery
Primary Surgical Approaches Used for Implantation of InductOs	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.	During surgery
The Interbody Device Brand/Generic Names Used With InductOs	The number of spine levels with InductOs is presented by interbody brand/generic names.	during surgery
Placement of the Matrix Wetted With InductOs	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.	During surgery
Supplemental Fixation	The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization).	During surgery
Instrumentations Used for Stabilization	The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Adverse Events of Interest	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).	12 months
AEI Categorisation	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.	12 months
The Number of Subjects Having Secondary Spine Surgical Intervention	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.	12 months
The Number of Unplanned Secondary Spine Interventions in Subgroups	The number of unplanned secondary spine interventions is reported by subgroups (smoker, non-smoker, diabetics, and non-diabetics).	12 months
Fusion Status at the Last Assessment Performed by 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.	12 months
Fusion Rates in Subgroups	Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.	12 months

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics
• Investigators: Principal Investigator: Norbert Passuti, Pr, CHU de Nantes

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: October 29, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: InductOs; France; Retrospective; Fusion; rhBMP-2; real world use
• Other Study ID Numbers: 2.05.8005