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

• Sponsor: Medtronic Spinal and Biologics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02280187
• Collaborator: (none)
• Enrollment: 400
• Locations: 10
• Duration (Months): 12
• Patients Per Site: 40
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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	Phase
Spine Fusion	Procedure: Spine Fusion

Study Design

• 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: Oct 1, 2014
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. The Primary Diagnostic Indication for InductOs Use [Baseline]

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

2. Spine Levels Treated [During surgery]

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

3. Primary Surgical Approaches Used for Implantation of InductOs [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 [during surgery]

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

5. Placement of the Matrix Wetted With InductOs [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 [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 [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 [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 [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 [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 [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 [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 [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Bordeaux- Centre Universitaire Pellegrin	Bordeaux		France
2	Centre Orthopedique Santy	Lyon		France
3	Hopital De La Timone Adultes	Marseille		France
4	Hopital Prive Clairval	Marseille		France
5	CHU de Nantes	Nantes		France
6	Centre Hospitalier Universitaire Nice - Hôpital Pasteur	Nice		France	06002
7	Nouvelle Clinique De L'Union	Saint-Jean		France
8	Clinique Du Parc à Saint -Priest en Jarez	Saint-Priest en Jarez		France
9	Hopital Civil	Strasbourg		France
10	Clinique Medipole Garonne	Toulouse		France

Sponsors and Collaborators

• Medtronic Spinal and Biologics

Investigators

• Principal Investigator: Norbert Passuti, Pr, CHU de Nantes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Spinal and Biologics
• ClinicalTrials.gov Identifier: NCT02280187
• Other Study ID Numbers: 2.05.8005
• First Posted: Oct 31, 2014
• Last Update Posted: Feb 6, 2017
• Last Verified: Dec 1, 2016

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

Study Results

Participant Flow

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Period Title: Overall Study
STARTED	400
COMPLETED	182
NOT COMPLETED	218

Baseline Characteristics

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Overall Participants	400
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.5 (14.8)
Gender (Count of Participants)
Female	237 59.3%
Male	163 40.8%
Smoking Status (participants) [Number]
Current smoker	110 27.5%
Not currently smoking	267 66.8%
Not available	23 5.8%
Medical history with or without Diabetes (participants) [Number]
Diabetics	29 7.3%
Non-diabetics	371 92.8%

Outcome Measures

1. Primary Outcome

Title	The Primary Diagnostic Indication for InductOs Use
Description	The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
Degenerative disc disease (DDD)	32.3 8.1%
Disc herniation	4.5 1.1%
Stenosis	3.5 0.9%
Spondylolisthesis	29.8 7.5%
Spondylosis (e.g. osteoarthritis)	0.8 0.2%
Deformity (i.e. Scoliosis, kyphosis)	14.8 3.7%
Pseudoarthrosis	7.3 1.8%
Trauma	2.3 0.6%
Other	5.0 1.3%

2. Primary Outcome

Title	Spine Levels Treated
Description	The number of spine levels from the occiput to S1 is presented.
Time Frame	During surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
Measure Spine level	634
Occiput-C1	0
C1-C2	1
C2-C3	0
C3-C4	0
C4-C5	0
C5-C6	0
C6-C7	0
C7-T1	0
T1-T2	0
T2-T3	2
T3-T4	2
T4-T5	3
T5-T6	4
T6-T7	5
T7-T8	3
T8-T9	4
T9-T10	5
T10-T11	8
T11-T12	9
T12-L1	15
L1-L2	18
L2-L3	46
L3-L4	106
L4-L5	214
L5-S1	189

3. Primary Outcome

Title	Primary Surgical Approaches Used for Implantation of InductOs
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
Measure Spine level	634
ALIF	188
PLIF	111
TLIF	4
LLIF	106
PLF	221
Other	4

4. Primary Outcome

Title	The Interbody Device Brand/Generic Names Used With InductOs
Description	The number of spine levels with InductOs is presented by interbody brand/generic names.
Time Frame	during surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
Measure Spine level	634
Capstone	26
Crescent	3
Juliet An	2
Perimeter	91
Pyramesh	4
Roi	43
Roi-A	26
Roi-T	5
Sovereign	45
Synfix-Lr	9
Vlift	5
Other	96
No Cage Used	271
Not Available	8

5. Primary Outcome

Title	Placement of the Matrix Wetted With InductOs
Description	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

Outcome Measure Data

Analysis Population Description

The total levels across all the rows are higher than total number of levels analyzed because multiple answers are possible.

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
Measure Spine level	634
Posterior lateral	270
Interbody (inside the cage)	335
Interbody (between the cage)	60
Interbody (outside cage)	22
Other placement	20

6. Primary Outcome

Title	Supplemental Fixation
Description	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

Outcome Measure Data

Analysis Population Description

The total levels across all the rows are higher than total number of levels analyzed because some levels may be represented in more than one rows.

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
Measure Spine level	634
Anterior stabilization	200
Posterior stabilization	399
No stabilization	99

7. Primary Outcome

Title	Instrumentations Used for Stabilization
Description	The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.
Time Frame	during surgery

Outcome Measure Data

Analysis Population Description

The total levels in the summary are higher than total amount of levels because multiple answers are possible.

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
Measure Spine level	634
Screws	454
Rods	394
Plates	105
Other	77

8. Secondary Outcome

Title	The Number of Adverse Events of Interest
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
Number [events]	31

9. Secondary Outcome

Title	AEI Categorisation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
Measure adverse event	31
Exuberant bone formation/heterotopic bone growth	0
Excessive bone resorption	1
Nerve compression or nerve root disorders	3
Allergic reactions or inflammation	1
Fluid collection at the site of implant	5
Device (implant) displacement	7
Male fertility problems	1
Neoplasms (benign, malignant,and unspecified)	1
Other Adverse Event of interest	12

10. Secondary Outcome

Title	The Number of Subjects Having Secondary Spine Surgical Intervention
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
subjects having planned secondary spine surgery	3 0.8%
subjects having unplanned secondary spine surgery	9 2.3%

11. Secondary Outcome

Title	The Number of Unplanned Secondary Spine Interventions in Subgroups
Description	The number of unplanned secondary spine interventions is reported by subgroups (smoker, non-smoker, diabetics, and non-diabetics).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	400
unplanned secondary surgeries in smokers (n=110)	2 0.5%
unplanned secondary surgeries in nonsmokers(n=267)	1 0.3%
unplanned secondary surgeries-diabetics (n=29)	0 0%
unplanned secondary surgeries-nondiabetics (n=371)	3 0.8%

12. Secondary Outcome

Title	Fusion Status at the Last Assessment Performed by 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

The subjects with the image that unable to determine fusion status and the assessment not done" were not taken into account.

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	266
Fusion success	73.3 18.3%
Fusion failed	26.7 6.7%

13. Secondary Outcome

Title	Fusion Rates in Subgroups
Description	Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
Measure Participants	266
Successful fusion rate in smokers (n=77)	72.7 18.2%
Successful fusion rate in non-smokers (n=179)	74.3 18.6%
Successful fusion rate in diabetics (n=14)	78.6 19.7%
Successful fusion rate in non-diabetics (n=252)	73.0 18.3%

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	This is a retrospective study. During this study, all Adverse Events of Interest (AEIs) that occurred after the application of InductOs were collected. Please see secondary outcome 8 (the number of AEIs) for the definition of AEI. The table below contains all AEI, regardless of seriousness.
Arm/Group Title	Spine Fusion With InductOs
Arm/Group Description	Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012 Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
All Cause Mortality
	Spine Fusion With InductOs
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Spine Fusion With InductOs
	Affected / at Risk (%)	# Events
Total	27/400 (6.8%)
Congenital, familial and genetic disorders
Meningocele	1/400 (0.3%)	1
Gastrointestinal disorders
Intestinal Obstruction	1/400 (0.3%)	1
General disorders
Device Breakage	1/400 (0.3%)	1
Device Deployment Issue	1/400 (0.3%)	1
Device Dislocation	2/400 (0.5%)	2
Implant Site Haematoma	1/400 (0.3%)	1
Infections and infestations
Bacterial Sepsis	1/400 (0.3%)	1
Endocarditis Staphylococcal	1/400 (0.3%)	1
Postoperative Wound Infection	1/400 (0.3%)	1
Wound Infection Staphylococcal	1/400 (0.3%)	1
Injury, poisoning and procedural complications
Extradural Haematoma	2/400 (0.5%)	2
Post Procedural Haematoma	2/400 (0.5%)	2
Post Procedural Inflammation	1/400 (0.3%)	1
Postoperative Wound Complication	1/400 (0.3%)	1
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis	1/400 (0.3%)	1
Osteoporotic Fracture	1/400 (0.3%)	1
Pseudarthrosis	4/400 (1%)	4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal Meningioma Benign	1/400 (0.3%)	1
Nervous system disorders
Carotid Artery Stenosis	1/400 (0.3%)	1
Motor Dysfunction	1/400 (0.3%)	1
Neuralgia	1/400 (0.3%)	1
Radiculitis Lumbosacral	1/400 (0.3%)	1
Sciatica	1/400 (0.3%)	1
Spinal Cord Ischaemia	1/400 (0.3%)	1
Reproductive system and breast disorders
Retrograde Ejaculation	1/400 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Spine Fusion With InductOs
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.