Trial Outcomes & Findings for Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion (NCT NCT01714804)
NCT ID: NCT01714804
Last Updated: 2018-01-23
Results Overview
Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
12 months
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
Accell Evo3
Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
|
Infuse
Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space. Subjects in this treatment arm were historical controls and were not enrolled in this study.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prospective
n=29 Participants
Accell Evo3
Accell Evo3 prospective study arm
|
Retrospective
n=30 Participants
Infuse
rh-BMP2 retrospective study arm
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>18 years old
|
29 Participants
n=29 Participants
|
30 Participants
n=30 Participants
|
59 Participants
n=59 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=29 Participants
|
17 Participants
n=30 Participants
|
33 Participants
n=59 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=29 Participants
|
13 Participants
n=30 Participants
|
26 Participants
n=59 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
30 participants
n=30 Participants
|
59 participants
n=59 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: One level is defined as a spinal segment in the lumbar spine.
Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately
Outcome measures
| Measure |
Accell Evo3
n=36 levels
Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 to S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
|
Infuse
n=37 levels
Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 to S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space.
|
|---|---|---|
|
Number of Levels With Posterolateral Fusion
|
23 levels
|
26 levels
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Accell Evo3
Serious events: 7 serious events
Other events: 6 other events
Deaths: 0 deaths
Infuse
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Accell Evo3
n=29 participants at risk
Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
|
Infuse
n=30 participants at risk
Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hematoma
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Skin and subcutaneous tissue disorders
epidural hematoma
|
0.00%
0/29 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
3.3%
1/30 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Musculoskeletal and connective tissue disorders
Adjacent segment disease
|
6.9%
2/29 • Number of events 2 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
3.3%
1/30 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Cardiac disorders
Blood Pressure increase
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Eye disorders
Cataract surgery
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Musculoskeletal and connective tissue disorders
carpal tunnel trigger finger
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Musculoskeletal and connective tissue disorders
CMC arthroplasty, thumb
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Musculoskeletal and connective tissue disorders
headache, rib and back pain
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Musculoskeletal and connective tissue disorders
Upper extremity numbness; guyon's canal release
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Surgery for lipoma, right flank
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
Other adverse events
| Measure |
Accell Evo3
n=29 participants at risk
Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
|
Infuse
n=30 participants at risk
Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Musculoskeletal and connective tissue disorders
Flare up of hip pain
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Nervous system disorders
Buttox pain
|
0.00%
0/29 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
3.3%
1/30 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Nervous system disorders
Neuropathy
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Musculoskeletal and connective tissue disorders
Back and thigh pain (stinging)
|
3.4%
1/29 • Number of events 2 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Nervous system disorders
Numbness
|
6.9%
2/29 • Number of events 2 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Infections and infestations
Fever and burning around incision
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Renal and urinary disorders
Urinary retention
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Musculoskeletal and connective tissue disorders
Adjacent segment disease
|
0.00%
0/29 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
6.7%
2/30 • Number of events 2 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/29 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
3.3%
1/30 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Renal and urinary disorders
Dysuria/stress incontinence
|
0.00%
0/29 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
3.3%
1/30 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/29 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
3.3%
1/30 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
|
Musculoskeletal and connective tissue disorders
Neck and low back pain
|
3.4%
1/29 • Number of events 1 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
0.00%
0/30 • Up to 24 months post surgery
Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
Additional Information
Vice President, Orthobiologics Research & Development
SeaSpine
Phone: 760.216.5138
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator may not submit the results of the study for publication, without the sponsor's prior permission.
- Publication restrictions are in place
Restriction type: OTHER