Trial Outcomes & Findings for InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study (NCT NCT02280187)

NCT ID: NCT02280187

Last Updated: 2017-02-06

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 400 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2017-02-06

Participant Flow

Participant milestones

Measure	Spine Fusion With InductOs 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 Study STARTED	400
Overall Study COMPLETED	182
Overall Study NOT COMPLETED	218

Reasons for withdrawal

Measure	Spine Fusion With InductOs 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 Study Lost to Follow-up	218

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Spine Fusion With InductOs n=400 Participants 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.
Age, Continuous	54.5 years STANDARD_DEVIATION 14.8 • n=5 Participants
Gender Female	237 Participants n=5 Participants
Gender Male	163 Participants n=5 Participants
Smoking Status Current smoker	110 participants n=5 Participants
Smoking Status Not currently smoking	267 participants n=5 Participants
Smoking Status Not available	23 participants n=5 Participants
Medical history with or without Diabetes Diabetics	29 participants n=5 Participants
Medical history with or without Diabetes Non-diabetics	371 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Spine Fusion With InductOs n=400 Participants 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.
The Primary Diagnostic Indication for InductOs Use Spondylolisthesis	29.8 percentage of participants
The Primary Diagnostic Indication for InductOs Use Degenerative disc disease (DDD)	32.3 percentage of participants
The Primary Diagnostic Indication for InductOs Use Disc herniation	4.5 percentage of participants
The Primary Diagnostic Indication for InductOs Use Stenosis	3.5 percentage of participants
The Primary Diagnostic Indication for InductOs Use Spondylosis (e.g. osteoarthritis)	0.8 percentage of participants
The Primary Diagnostic Indication for InductOs Use Deformity (i.e. Scoliosis, kyphosis)	14.8 percentage of participants
The Primary Diagnostic Indication for InductOs Use Pseudoarthrosis	7.3 percentage of participants
The Primary Diagnostic Indication for InductOs Use Trauma	2.3 percentage of participants
The Primary Diagnostic Indication for InductOs Use Other	5.0 percentage of participants

PRIMARY outcome

Timeframe: During surgery

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

Outcome measures

Measure	Spine Fusion With InductOs n=634 Spine level 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.
Spine Levels Treated Occiput-C1	0 spine level
Spine Levels Treated C1-C2	1 spine level
Spine Levels Treated C2-C3	0 spine level
Spine Levels Treated C3-C4	0 spine level
Spine Levels Treated C4-C5	0 spine level
Spine Levels Treated C5-C6	0 spine level
Spine Levels Treated C6-C7	0 spine level
Spine Levels Treated C7-T1	0 spine level
Spine Levels Treated T1-T2	0 spine level
Spine Levels Treated T2-T3	2 spine level
Spine Levels Treated T3-T4	2 spine level
Spine Levels Treated T4-T5	3 spine level
Spine Levels Treated T5-T6	4 spine level
Spine Levels Treated T6-T7	5 spine level
Spine Levels Treated T7-T8	3 spine level
Spine Levels Treated T8-T9	4 spine level
Spine Levels Treated T9-T10	5 spine level
Spine Levels Treated T10-T11	8 spine level
Spine Levels Treated T11-T12	9 spine level
Spine Levels Treated T12-L1	15 spine level
Spine Levels Treated L1-L2	18 spine level
Spine Levels Treated L2-L3	46 spine level
Spine Levels Treated L3-L4	106 spine level
Spine Levels Treated L4-L5	214 spine level
Spine Levels Treated L5-S1	189 spine level

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Spine Fusion With InductOs n=634 Spine level 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.
Primary Surgical Approaches Used for Implantation of InductOs ALIF	188 spine level
Primary Surgical Approaches Used for Implantation of InductOs PLIF	111 spine level
Primary Surgical Approaches Used for Implantation of InductOs TLIF	4 spine level
Primary Surgical Approaches Used for Implantation of InductOs LLIF	106 spine level
Primary Surgical Approaches Used for Implantation of InductOs PLF	221 spine level
Primary Surgical Approaches Used for Implantation of InductOs Other	4 spine level

PRIMARY outcome

Timeframe: during surgery

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

Outcome measures

Measure	Spine Fusion With InductOs n=634 Spine level 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.
The Interbody Device Brand/Generic Names Used With InductOs Perimeter	91 spine level
The Interbody Device Brand/Generic Names Used With InductOs Pyramesh	4 spine level
The Interbody Device Brand/Generic Names Used With InductOs Roi	43 spine level
The Interbody Device Brand/Generic Names Used With InductOs Roi-A	26 spine level
The Interbody Device Brand/Generic Names Used With InductOs Roi-T	5 spine level
The Interbody Device Brand/Generic Names Used With InductOs Sovereign	45 spine level
The Interbody Device Brand/Generic Names Used With InductOs Synfix-Lr	9 spine level
The Interbody Device Brand/Generic Names Used With InductOs Vlift	5 spine level
The Interbody Device Brand/Generic Names Used With InductOs Other	96 spine level
The Interbody Device Brand/Generic Names Used With InductOs Capstone	26 spine level
The Interbody Device Brand/Generic Names Used With InductOs No Cage Used	271 spine level
The Interbody Device Brand/Generic Names Used With InductOs Not Available	8 spine level
The Interbody Device Brand/Generic Names Used With InductOs Crescent	3 spine level
The Interbody Device Brand/Generic Names Used With InductOs Juliet An	2 spine level

PRIMARY outcome

Timeframe: During surgery

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

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.

Outcome measures

Measure	Spine Fusion With InductOs n=634 Spine level 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.
Placement of the Matrix Wetted With InductOs Posterior lateral	270 spine level
Placement of the Matrix Wetted With InductOs Interbody (inside the cage)	335 spine level
Placement of the Matrix Wetted With InductOs Interbody (between the cage)	60 spine level
Placement of the Matrix Wetted With InductOs Interbody (outside cage)	22 spine level
Placement of the Matrix Wetted With InductOs Other placement	20 spine level

PRIMARY outcome

Timeframe: During surgery

Population: 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.

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

Outcome measures

Measure	Spine Fusion With InductOs n=634 Spine level 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.
Supplemental Fixation Anterior stabilization	200 spine level
Supplemental Fixation Posterior stabilization	399 spine level
Supplemental Fixation No stabilization	99 spine level

PRIMARY outcome

Timeframe: during surgery

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

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

Outcome measures

Measure	Spine Fusion With InductOs n=634 Spine level 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.
Instrumentations Used for Stabilization Screws	454 spine level
Instrumentations Used for Stabilization Rods	394 spine level
Instrumentations Used for Stabilization Plates	105 spine level
Instrumentations Used for Stabilization Other	77 spine level

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Spine Fusion With InductOs n=400 Participants 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.
The Number of Adverse Events of Interest	31 events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Spine Fusion With InductOs n=31 adverse event 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.
AEI Categorisation Exuberant bone formation/heterotopic bone growth	0 events
AEI Categorisation Excessive bone resorption	1 events
AEI Categorisation Nerve compression or nerve root disorders	3 events
AEI Categorisation Allergic reactions or inflammation	1 events
AEI Categorisation Fluid collection at the site of implant	5 events
AEI Categorisation Device (implant) displacement	7 events
AEI Categorisation Male fertility problems	1 events
AEI Categorisation Neoplasms (benign, malignant,and unspecified)	1 events
AEI Categorisation Other Adverse Event of interest	12 events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Spine Fusion With InductOs n=400 Participants 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.
The Number of Subjects Having Secondary Spine Surgical Intervention subjects having planned secondary spine surgery	3 participants
The Number of Subjects Having Secondary Spine Surgical Intervention subjects having unplanned secondary spine surgery	9 participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Spine Fusion With InductOs n=400 Participants 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.
The Number of Unplanned Secondary Spine Interventions in Subgroups unplanned secondary surgeries in smokers (n=110)	2 participants
The Number of Unplanned Secondary Spine Interventions in Subgroups unplanned secondary surgeries in nonsmokers(n=267)	1 participants
The Number of Unplanned Secondary Spine Interventions in Subgroups unplanned secondary surgeries-diabetics (n=29)	0 participants
The Number of Unplanned Secondary Spine Interventions in Subgroups unplanned secondary surgeries-nondiabetics (n=371)	3 participants

SECONDARY outcome

Timeframe: 12 months

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

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.

Outcome measures

Measure	Spine Fusion With InductOs n=266 Participants 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.
Fusion Status at the Last Assessment Performed by 12 Months Fusion success	73.3 percentage of participants
Fusion Status at the Last Assessment Performed by 12 Months Fusion failed	26.7 percentage of participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Spine Fusion With InductOs n=266 Participants 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.
Fusion Rates in Subgroups Successful fusion rate in smokers (n=77)	72.7 percentage of participants
Fusion Rates in Subgroups Successful fusion rate in non-smokers (n=179)	74.3 percentage of participants
Fusion Rates in Subgroups Successful fusion rate in diabetics (n=14)	78.6 percentage of participants
Fusion Rates in Subgroups Successful fusion rate in non-diabetics (n=252)	73.0 percentage of participants

Adverse Events

Spine Fusion With InductOs

Serious events: 27 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Spine Fusion With InductOs n=400 participants at risk 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.
Congenital, familial and genetic disorders Meningocele	0.25% 1/400 • Number of events 1 • 12 months 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.
Gastrointestinal disorders Intestinal Obstruction	0.25% 1/400 • Number of events 1 • 12 months 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.
General disorders Device Breakage	0.25% 1/400 • Number of events 1 • 12 months 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.
General disorders Device Deployment Issue	0.25% 1/400 • Number of events 1 • 12 months 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.
General disorders Device Dislocation	0.50% 2/400 • Number of events 2 • 12 months 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.
General disorders Implant Site Haematoma	0.25% 1/400 • Number of events 1 • 12 months 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.
Infections and infestations Bacterial Sepsis	0.25% 1/400 • Number of events 1 • 12 months 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.
Infections and infestations Endocarditis Staphylococcal	0.25% 1/400 • Number of events 1 • 12 months 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.
Infections and infestations Postoperative Wound Infection	0.25% 1/400 • Number of events 1 • 12 months 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.
Infections and infestations Wound Infection Staphylococcal	0.25% 1/400 • Number of events 1 • 12 months 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.
Injury, poisoning and procedural complications Extradural Haematoma	0.50% 2/400 • Number of events 2 • 12 months 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.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.50% 2/400 • Number of events 2 • 12 months 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.
Injury, poisoning and procedural complications Post Procedural Inflammation	0.25% 1/400 • Number of events 1 • 12 months 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.
Injury, poisoning and procedural complications Postoperative Wound Complication	0.25% 1/400 • Number of events 1 • 12 months 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.
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.25% 1/400 • Number of events 1 • 12 months 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.
Musculoskeletal and connective tissue disorders Osteoporotic Fracture	0.25% 1/400 • Number of events 1 • 12 months 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.
Musculoskeletal and connective tissue disorders Pseudarthrosis	1.0% 4/400 • Number of events 4 • 12 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal Meningioma Benign	0.25% 1/400 • Number of events 1 • 12 months 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.
Nervous system disorders Carotid Artery Stenosis	0.25% 1/400 • Number of events 1 • 12 months 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.
Nervous system disorders Motor Dysfunction	0.25% 1/400 • Number of events 1 • 12 months 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.
Nervous system disorders Neuralgia	0.25% 1/400 • Number of events 1 • 12 months 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.
Nervous system disorders Radiculitis Lumbosacral	0.25% 1/400 • Number of events 1 • 12 months 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.
Nervous system disorders Sciatica	0.25% 1/400 • Number of events 1 • 12 months 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.
Nervous system disorders Spinal Cord Ischaemia	0.25% 1/400 • Number of events 1 • 12 months 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.
Reproductive system and breast disorders Retrograde Ejaculation	0.25% 1/400 • Number of events 1 • 12 months 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.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Department

Medtronic Spinal and Biologics

Phone: 1800-876-3133

Email: msbkclinicalresearch@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60