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

Spine Fusion Clinical Trial

— InductOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280187
• Other study ID #: 2.05.8005
• Status: Completed
• Phase: N/A
• First received: October 29, 2014
• Last updated: January 26, 2016
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Conseil National de l'Ordre des Médecins
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Spine Fusion

Intervention

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

Locations

Country	Name	City	State
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary indication	To understand for which primary diagnostic indication patients are treated with InductOs during spine fusion surgery in France. The frequency will be presented for each of these primary diagnostic indications: Degenerative disc disease (DDD), Disc herniation, Stenosis, Spondylolisthesis, Spondylosis (e.g. osteoarthritis), Deformity (i.e. Scoliosis, kyphosis), Pseudoarthrosis, Trauma and any other indication	At pre-operative visit	No
Primary	Spine levels treated	The frequency of each spine level(s) treated with InductOs will be presented (from the occiput to S1)	During surgery	No
Primary	Type of Procedure type (surgical approach)	The approaches used to implant InductOs will be classified as follow ALIF, PLIF, TLIF, LLIF (including DLIF and XLIF), Posterolateral fusion (PLF)	During surgery	No
Primary	Placement of the matrix wetted with InductOs	The placement of the matrix will be classified as: Posterior lateral or Interbody space (Inside the cage, between the cage or outside the cage). Any other placement will be specified.	During surgery	No
Primary	Type of supplemental fixation	To describe if stabilization was performed and whether it was an Anterior or Posterior stabilization	During surgery	No
Secondary	Adverse events of interest through 12-months	These events will be summarized by categories and Preferred Terms.	12 months	Yes