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Completed

NCT Number: NCT02280187

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

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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Key information

Conditions

Spine Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux- Centre Universitaire Pellegrin, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spine Fusion

Procedure

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

Primary outcomes

  1. The Primary Diagnostic Indication for InductOs Use

    Time frame: Baseline

    The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.

  2. Spine Levels Treated

    Time frame: During surgery

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

  3. Primary Surgical Approaches Used for Implantation of InductOs

    Time frame: 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.

  4. The Interbody Device Brand/Generic Names Used With InductOs

    Time frame: during surgery

    The number of spine levels with InductOs is presented by interbody brand/generic names.

  5. Placement of the Matrix Wetted With InductOs

    Time frame: 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.

  6. Supplemental Fixation

    Time frame: During surgery

    The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization).

  7. Instrumentations Used for Stabilization

    Time frame: during surgery

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

Secondary outcomes

  1. The Number of Adverse Events of Interest

    Time frame: 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).

  2. AEI Categorisation

    Time frame: 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.

  3. The Number of Subjects Having Secondary Spine Surgical Intervention

    Time frame: 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.

  4. The Number of Unplanned Secondary Spine Interventions in Subgroups

    Time frame: 12 months

    The number of unplanned secondary spine interventions is reported by subgroups (smoker, non-smoker, diabetics, and non-diabetics).

  5. Fusion Status at the Last Assessment Performed by 12 Months

    Time frame: 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.

  6. Fusion Rates in Subgroups

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Medtronic Spinal and Biologics

Industry

Registry information

Acronym: InductOR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2014
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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