Trial Outcomes & Findings for Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion (NCT NCT01430299)
NCT ID: NCT01430299
Last Updated: 2018-06-07
Results Overview
Posterolateral fusion by radiographic assessment 12 months post surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
12 months
Results posted on
2018-06-07
Participant Flow
Participant milestones
| Measure |
OsteoSurg 300
Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
|
rhBMP-2
Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
23
|
|
Overall Study
COMPLETED
|
16
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
Baseline characteristics by cohort
| Measure |
OsteoSurg 300
n=16 Participants
Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
|
rhBMP-2
n=21 Participants
Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
participants over 18 years of age
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: One to 3 spinal levels between L3 and S1 were treated per patient. Fusion was assessed twice per treated level. There were 23 OsteoSurge 300 levels and 37 rhBMP-2 levels but 46 OsteoSurge assessments and 74 rhBMP-2 assessments.
Posterolateral fusion by radiographic assessment 12 months post surgery
Outcome measures
| Measure |
OsteoSurg 300
n=46 radiographic assessments
Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
|
rhBMP-2
n=74 radiographic assessments
Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
|
|---|---|---|
|
Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery
|
43 radiographic assessments
|
74 radiographic assessments
|
Adverse Events
OsteoSurg 300
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
rhBMP-2
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OsteoSurg 300
n=16 participants at risk
Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
|
rhBMP-2
n=21 participants at risk
Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hematoma
|
6.2%
1/16 • Number of events 1 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
|
Nervous system disorders
Loss of sensory and/or motor function
|
6.2%
1/16 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
|
Cardiac disorders
Myocardial Infarction
|
6.2%
1/16 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
|
Nervous system disorders
Neurologic deficit
|
6.2%
1/16 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
|
Nervous system disorders
Unresolved pain
|
6.2%
1/16 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.2%
1/16 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory issues
|
0.00%
0/16 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
OsteoSurg 300
n=16 participants at risk
Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
|
rhBMP-2
n=21 participants at risk
Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
|
|---|---|---|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/16 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Fractured Toe
|
6.2%
1/16 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
|
Nervous system disorders
Dural Tear
|
18.8%
3/16 • Number of events 3 • 24 months
|
19.0%
4/21 • Number of events 4 • 24 months
|
|
Nervous system disorders
Gait disturbance
|
0.00%
0/16 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
|
Nervous system disorders
Loss of sensory and/or motor function
|
6.2%
1/16 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/16 • 24 months
|
9.5%
2/21 • Number of events 2 • 24 months
|
|
Nervous system disorders
Numbness/Tingling
|
0.00%
0/16 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
|
Nervous system disorders
Unresolved Pain
|
50.0%
8/16 • Number of events 11 • 24 months
|
42.9%
9/21 • Number of events 14 • 24 months
|
|
Blood and lymphatic system disorders
Swelling
|
0.00%
0/16 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
|
Cardiac disorders
Thrombosis
|
0.00%
0/16 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
Additional Information
Vice President, Orthobiologics Research & Development
SeaSpine
Phone: 760.216.5138
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60