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

NCT02280187 | Completed Results

• 1 other identifier: 2.05.8005
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 10

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.

Conditions

Spine Fusion

Keywords

InductOs; rhBMP-2; Retrospective; France; Fusion; real world use

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• The Number of Adverse Events of Interest

  12 months

• AEI Categorisation

  12 months

• The Number of Subjects Having Secondary Spine Surgical Intervention

  12 months

• The Number of Unplanned Secondary Spine Interventions in Subgroups

  12 months

• Fusion Status at the Last Assessment Performed by 12 Months

  12 months

Study Arms (1)

Spine Fusion with InductOs

Patient had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012

Procedure: Spine Fusion

Interventions

Spine Fusion PROCEDURE

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

Spine Fusion with InductOs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (10)

CHU de Bordeaux- Centre Universitaire Pellegrin

Bordeaux, France

Location

Centre Orthopedique Santy

Lyon, France

Location

Hopital De La Timone Adultes

Marseille, France

Location

Hopital Prive Clairval

Marseille, France

Location

CHU de Nantes

Nantes, France

Location

Centre Hospitalier Universitaire Nice - Hôpital Pasteur

Nice, 06002, France

Location

Nouvelle Clinique De L'Union

Saint-Jean, France

Location

Clinique Du Parc à Saint -Priest en Jarez

Saint-Priest-en-Jarez, France

Location

Hopital Civil

Strasbourg, France

Location

Clinique Medipole Garonne

Toulouse, France

Location

Results Point of Contact

• Title: Clinical Department
• Organization: Medtronic Spinal and Biologics

msbkclinicalresearch@medtronic.com

1800-876-3133

Study Officials

• Norbert Passuti, Pr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 6, 2017
• Results First Posted: February 6, 2017

Record last verified: 2016-12

Locations

FR (10)