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

Medtronic Spinal and Biologics400 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

400

Conditions

Spine Fusion

Interventions

Spine FusionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

CHU de Bordeaux- Centre Universitaire Pellegrin

Bordeaux, France

Centre Orthopedique Santy

Lyon, France

Hopital De La Timone Adultes

Marseille, France

Hopital Prive Clairval

Marseille, France

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Spine Levels Treated

The number of spine levels from the occiput to S1 is presented.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: During surgery

Instrumentations Used for Stabilization

The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.

Data from ClinicalTrials.gov

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Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 12 months

Fusion Rates in Subgroups

Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.

Time frame: 12 months