ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02280187
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Spine Fusion Procedure: Spine Fusion

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study
Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280187


Locations
France
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
CHU de Nantes
Nantes, France
Centre Hospitalier Universitaire Nice - Hôpital Pasteur
Nice, France, 06002
Nouvelle Clinique De L'Union
Saint-Jean, France
Clinique Du Parc à Saint -Priest en Jarez
Saint-Priest en Jarez, France
Hopital Civil
Strasbourg, France
Clinique Medipole Garonne
Toulouse, France
Sponsors and Collaborators
Medtronic Spinal and Biologics
Investigators
Principal Investigator: Norbert Passuti, Pr CHU de Nantes

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT02280187     History of Changes
Other Study ID Numbers: 2.05.8005
First Posted: October 31, 2014    Key Record Dates
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017
Last Verified: December 2016

Keywords provided by Medtronic Spinal and Biologics:
InductOs
rhBMP-2
Retrospective
France
Fusion
real world use