Trial Outcomes & Findings for Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects (NCT NCT01878149)
NCT ID: NCT01878149
Last Updated: 2014-08-12
Results Overview
Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.
Recruitment status
COMPLETED
Target enrollment
34 participants
Primary outcome timeframe
Observed for up to 6 months post-surgery
Results posted on
2014-08-12
Participant Flow
Consecutive subjects at each site meeting all of the study eligibility criteria and who were treated with LLIF using the VEO® or XLIF® systems at least 3 months prior to the date the data is collected were included in this evaluation.
The Sponsor originally collected data on 38 subjects, 21 subjects in the VEO treatment arm and 17 subjects in the XLIF® treatment arm, from a total of five sites. Four study subjects (two subjects from each study arm) were excluded from the final evaluation as they did not meet the inclusion/exclusion criteria.
Participant milestones
| Measure |
VEO® Lateral Access and Interbody Fusion System
VEO® is the brand name for the Baxano Surgical LLIF system, which employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. The VEO® system was developed with an initial, radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. Dissection through the psoas is then performed with direct vision in conjunction with EMG. The psoas muscle is split anterior-posterior along muscle fiber lines and the retraction is performed with two independent blades. Insertion depth may be varied to avoid muscle creep, and the toed-out blade tips are positioned under the psoas to hold the system in place. An inner sleeve is inserted to lock the blades in place at the desired radial tension for a customizable disc space exposure. Standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
|
eXtreme Lumbar Interbody Fusion (XLIF®)
The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc.When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
17
|
|
Overall Study
COMPLETED
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
VEO® Lateral Access and Interbody Fusion System
VEO® is the brand name for the Baxano Surgical LLIF system, which employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. The VEO® system was developed with an initial, radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. Dissection through the psoas is then performed with direct vision in conjunction with EMG. The psoas muscle is split anterior-posterior along muscle fiber lines and the retraction is performed with two independent blades. Insertion depth may be varied to avoid muscle creep, and the toed-out blade tips are positioned under the psoas to hold the system in place. An inner sleeve is inserted to lock the blades in place at the desired radial tension for a customizable disc space exposure. Standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
|
eXtreme Lumbar Interbody Fusion (XLIF®)
The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc.When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
|
|---|---|---|
|
Overall Study
Did Not Meet Eligibility Criteria
|
2
|
2
|
Baseline Characteristics
Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects
Baseline characteristics by cohort
| Measure |
VEO® Lateral Access and Interbody Fusion System
n=19 Participants
This study included adult men and women (\> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the VEO® spinal procedure. VEO® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
|
eXtreme Lumbar Interbody Fusion (XLIF®)
n=15 Participants
This study included adult men and women (\> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the XLIF® spinal procedure. XLIF® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.63 years
STANDARD_DEVIATION 13.13 • n=5 Participants
|
63 years
STANDARD_DEVIATION 12.35 • n=7 Participants
|
62.21 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
15 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Observed for up to 6 months post-surgeryPopulation: It was anticipated that approximately 40 subjects would be enrolled across the participating sites; 20 subjects in each treatment arm. Consecutive subjects who were treated with LLIF using the VEO® or XLIF® systems at least 3 months prior to the the data collection were included. The planned sample size was not statistically derived.
Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.
Outcome measures
| Measure |
VEO® Lateral Access and Interbody Fusion System
n=19 Participants
VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
|
eXtreme Lumbar Interbody Fusion (XLIF®)
n=15 Participants
The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
|
|---|---|---|
|
Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures
|
19 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Observed for up to 6 months post-surgeryIncidence of short term peri-operative adverse events (out to 6 months post-implant) including thigh pain, numbness, paresthesia and transient leg weakness.
Outcome measures
Outcome data not reported
Adverse Events
VEO® Lateral Access and Interbody Fusion System
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
eXtreme Lumbar Interbody Fusion (XLIF®)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VEO® Lateral Access and Interbody Fusion System
n=21 participants at risk
VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO® Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
|
eXtreme Lumbar Interbody Fusion (XLIF®)
n=17 participants at risk
The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
|
|---|---|---|
|
Blood and lymphatic system disorders
Deep venous thrombosis and GI prophylaxis
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Renal vein nicked
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure on a ventilator
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Severe Bleeding
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
Other adverse events
| Measure |
VEO® Lateral Access and Interbody Fusion System
n=21 participants at risk
VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO® Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
|
eXtreme Lumbar Interbody Fusion (XLIF®)
n=17 participants at risk
The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
|
|---|---|---|
|
Nervous system disorders
Lower extremity weakness
|
14.3%
3/21 • Number of events 3
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Decreased strength
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Lower extremity numbness
|
23.8%
5/21 • Number of events 5
|
17.6%
3/17 • Number of events 3
|
|
Nervous system disorders
Lower extremity pain
|
14.3%
3/21 • Number of events 3
|
23.5%
4/17 • Number of events 4
|
|
Nervous system disorders
Parasthesia
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
23.8%
5/21 • Number of events 5
|
5.9%
1/17 • Number of events 1
|
|
Surgical and medical procedures
Incisional Pain
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Surgical and medical procedures
Wound infection
|
0.00%
0/21
|
11.8%
2/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Limited flexion/extension at waist
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Surgical and medical procedures
Severe bleeding
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Surgical and medical procedures
Renal vein nicked
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Surgical and medical procedures
Wound ecchymosis
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Surgical and medical procedures
Respiratory failure
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
|
Surgical and medical procedures
Deep venous thrombosis prophylaxis and GI prophylaxis
|
0.00%
0/21
|
5.9%
1/17 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60