and Duo Interbody Fusion System Clinical Evaluation Rev H...Duo ª Interbody Fusion System Clinical...
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Duo ™ Interbody Fusion System Clinical Evaluation TM
Transcript of and Duo Interbody Fusion System Clinical Evaluation Rev H...Duo ª Interbody Fusion System Clinical...
Duo™ Interbody Fusion SystemClinical Evaluation
TM
Spineology Inc.7800 Third Street North, Suite 600Saint Paul, MN 55128-5455p: 888.377.4633 or 651.256.8533f: 651.256.8505
www.spineology.com
TM
A review of the type and rate of events reported for Spineology Duo Interbody Fusion compared to the Direct/Extreme Lumbar Interbody Fusion (XLIF®) is presented below. The overall incidence of peri-operative events observed in subjects treated with the Spineology Duo Interbody Fusion System is low and compares favorably to the literature. Note the five reoperations for the Duo subjects were due to the presence of foraminal stenosis that required supplemental decompression.
Comparison of Complications Between Direct/XLIF1 and the Spineology Duo Interbody Fusion System
EventDirect/XLIF Spineology Duo
# Patients Incidence (%) # Patients Incidence (%)
Total Events 4260 31.4 115 11.3Transient Sensory Deficit 2160 27.1 4.4
Neurological Deficit2
-- Temporary 2957 9.4 4.4-- Permanent 2525 2.5 0.0
Intra-op Complication3 2181 1.9 0.95
Wound Complication4 1254 0.8 0.0Reoperation 2193 3.74 4.36
Subsidence 1900 10.8 20 0.07
1Comparative analysis performed in accordance with definitions outlined in Joseph et. al. Comparison of complication rates of minimally invasive transforaminal lumbar interbody fusion and lateral lumbar interbody fusion: a systematic review of the literature. Neurosurg Focus 39 (4)E4,2015.2Defined as motor deficit.3Includes durotomies, instrument fractures, anterior longitudinal ligament rupture, abdominal wall paresis, vertebral body fractures, bowel injuries, and vascular injuries.4Wound complication includes superficial and deep infections, seromas, and hematomas.5One iliac vein injury repair that did not result in any neuro deficits.6Five additional surgical interventions for residual foraminal stenosis requiring supplemental decompression. 7Less than 1mm change observed from 6-weeks to 12-months post-op in analysis of subjects with 12-month CT scan imaging available.
® XLIF is a registered trademark of Nuvasive Inc.© Spineology Inc. January 2020 L530 Rev. H
Spineology Duo™ Interbody Fusion System
Clinical Evaluation
Early Findings of the RaDical Post-Market Lateral Lumbar Interbody Fusion (LLIF) Registry Study
Spineology is conducting a Post-Market Study of short-term and long-term outcomes in patients treated with the Duo Interbody Fusion System. This prospective, on-label, multi-site evaluation of 200 patients is Institutional Review Board (IRB)-approved and captures both subjective and objective patient data in a real-world, adult population.
Protocol Summary
This study is an evaluation of a maximum of 200 subjects enrolled at no more than 20 study sites. This registry-type evaluation collects data from the pre-operative visit through the 24-month post-operative visit. Data collection includes, but is not limited to, low back pain with a variety of lower extremity pain measurements on a 100mm Visual Analog Scale (VAS); subjective sensory and motor disturbance; low back function on the Oswestry Disability Index (ODI); patient satisfaction survey; objective neurological assessment of strength, sensation, and reflexes; standard peri-operative parameters; and independent radiologist fusion assessment of the 12-month post-op CT. At-a-Glance Early Results
Fifty-six percent (56%,115/200) of the study population is captured in the current data set.
Demographics Operative Levels L2-L3 L4-L5
• Gender: 61.7% Female, 38.3% Male • 91 Single-level Duo: 15.4% 57.0%
• Mean Age: 64.0 Years (range: 30 – 85) L2-L4
• BMI: 53.3% Obese (BMI > 30) • 24 Two-level Duo: 20.8%
A clinically meaningful improvement of low back function, defined as a 15-point reduction in the ODI score, is demonstrated early in the post-operative course and continues to improve over time.
High rates of patient satisfaction were observed early and sustained over time.
Subjects without baseline thigh pain (<20mm) were asked to rate their thigh pain and perceived hip weakness in flexion and extension on a 100mm scale. The self-reported subjective scores demonstrate that subjects did not experience clinically meaningful new onset or increased thigh symptoms (i.e., pain, hip flexion/extension weakness) post-operatively.
Case Studies
401-003: 58 YO obese (BMI of 34.16), diabetic female w/ neurogenic claudication and pelvic girdle dysfunction.
406-001: 51 YO obese (BMI of 38.8) diabetic male with collapsed disc space, Grade I spondylolisthesis and partial spina bifida with absence of right L5 lamina.
Variable Pre-op 6 Week 3 Month 6 Month 12 Month
Low Back Pain 68 0 1 0 0
Right Leg Pain 77 0 1 0 0
Left Leg Pain 48 0 1 0 0
Right Hip/Buttock Pain 78 0 1 0 0
Left Hip/Buttock Pain 57 0 1 0 0
Right Thigh Pain 0 0 0 0 0
Left Thigh Pain 0 0 0 0 0
ODI 62 10 0 2 0
Variable Pre-op 6 Week 3 Month 6 Month 12 Month
Low Back Pain 50 20 11 24 0
Right Leg Pain 37 0 1 0 8
Left Leg Pain 11 0 1 0 8
Right Hip/Buttock Pain 89 0 0 0 0
Left Hip/Buttock Pain 18 0 11 0 10
Right Thigh Pain 0 0 0 0 0
Left Thigh Pain 0 0 0 0 0
ODI 38 30 10 24 6
12 mo CT Coronal View
12 mo CT Coronal View
12 mo CT Sagittal View
12 mo CT Sagittal View
Pre-op 12 mo
Spineology Duo™ Interbody Fusion System
Clinical Evaluation
Early Findings of the RaDical Post-Market Lateral Lumbar Interbody Fusion (LLIF) Registry Study
Spineology is conducting a Post-Market Study of short-term and long-term outcomes in patients treated with the Duo Interbody Fusion System. This prospective, on-label, multi-site evaluation of 200 patients is Institutional Review Board (IRB)-approved and captures both subjective and objective patient data in a real-world, adult population.
Protocol Summary
This study is an evaluation of a maximum of 200 subjects enrolled at no more than 20 study sites. This registry-type evaluation collects data from the pre-operative visit through the 24-month post-operative visit. Data collection includes, but is not limited to, low back pain with a variety of lower extremity pain measurements on a 100mm Visual Analog Scale (VAS); subjective sensory and motor disturbance; low back function on the Oswestry Disability Index (ODI); patient satisfaction survey; objective neurological assessment of strength, sensation, and reflexes; standard peri-operative parameters; and independent radiologist fusion assessment of the 12-month post-op CT. At-a-Glance Early Results
Fifty-six percent (56%,115/200) of the study population is captured in the current data set.
Demographics Operative Levels L2-L3 L4-L5
• Gender: 61.7% Female, 38.3% Male • 91 Single-level Duo: 15.4% 57.0%
• Mean Age: 64.0 Years (range: 30 – 85) L2-L4
• BMI: 53.3% Obese (BMI > 30) • 24 Two-level Duo: 20.8%
A clinically meaningful improvement of low back function, defined as a 15-point reduction in the ODI score, is demonstrated early in the post-operative course and continues to improve over time.
High rates of patient satisfaction were observed early and sustained over time.
Subjects without baseline thigh pain (<20mm) were asked to rate their thigh pain and perceived hip weakness in flexion and extension on a 100mm scale. The self-reported subjective scores demonstrate that subjects did not experience clinically meaningful new onset or increased thigh symptoms (i.e., pain, hip flexion/extension weakness) post-operatively.
Case Studies
401-003: 58 YO obese (BMI of 34.16), diabetic female w/ neurogenic claudication and pelvic girdle dysfunction.
406-001: 51 YO obese (BMI of 38.8) diabetic male with collapsed disc space, Grade I spondylolisthesis and partial spina bifida with absence of right L5 lamina.
Variable Pre-op 6 Week 3 Month 6 Month 12 Month
Low Back Pain 68 0 1 0 0
Right Leg Pain 77 0 1 0 0
Left Leg Pain 48 0 1 0 0
Right Hip/Buttock Pain 78 0 1 0 0
Left Hip/Buttock Pain 57 0 1 0 0
Right Thigh Pain 0 0 0 0 0
Left Thigh Pain 0 0 0 0 0
ODI 62 10 0 2 0
Variable Pre-op 6 Week 3 Month 6 Month 12 Month
Low Back Pain 50 20 11 24 0
Right Leg Pain 37 0 1 0 8
Left Leg Pain 11 0 1 0 8
Right Hip/Buttock Pain 89 0 0 0 0
Left Hip/Buttock Pain 18 0 11 0 10
Right Thigh Pain 0 0 0 0 0
Left Thigh Pain 0 0 0 0 0
ODI 38 30 10 24 6
12 mo CT Coronal View
12 mo CT Coronal View
12 mo CT Sagittal View
12 mo CT Sagittal View
Pre-op 12 mo
Spineology Duo™ Interbody Fusion System
Clinical Evaluation
Early Findings of the RaDical Post-Market Lateral Lumbar Interbody Fusion (LLIF) Registry Study
Spineology is conducting a Post-Market Study of short-term and long-term outcomes in patients treated with the Duo Interbody Fusion System. This prospective, on-label, multi-site evaluation of 200 patients is Institutional Review Board (IRB)-approved and captures both subjective and objective patient data in a real-world, adult population.
Protocol Summary
This study is an evaluation of a maximum of 200 subjects enrolled at no more than 20 study sites. This registry-type evaluation collects data from the pre-operative visit through the 24-month post-operative visit. Data collection includes, but is not limited to, low back pain with a variety of lower extremity pain measurements on a 100mm Visual Analog Scale (VAS); subjective sensory and motor disturbance; low back function on the Oswestry Disability Index (ODI); patient satisfaction survey; objective neurological assessment of strength, sensation, and reflexes; standard peri-operative parameters; and independent radiologist fusion assessment of the 12-month post-op CT. At-a-Glance Early Results
Fifty-six percent (56%,115/200) of the study population is captured in the current data set.
Demographics Operative Levels L2-L3 L4-L5
• Gender: 61.7% Female, 38.3% Male • 91 Single-level Duo: 15.4% 57.0%
• Mean Age: 64.0 Years (range: 30 – 85) L2-L4
• BMI: 53.3% Obese (BMI > 30) • 24 Two-level Duo: 20.8%
A clinically meaningful improvement of low back function, defined as a 15-point reduction in the ODI score, is demonstrated early in the post-operative course and continues to improve over time.
High rates of patient satisfaction were observed early and sustained over time.
Subjects without baseline thigh pain (<20mm) were asked to rate their thigh pain and perceived hip weakness in flexion and extension on a 100mm scale. The self-reported subjective scores demonstrate that subjects did not experience clinically meaningful new onset or increased thigh symptoms (i.e., pain, hip flexion/extension weakness) post-operatively.
Case Studies
401-003: 58 YO obese (BMI of 34.16), diabetic female w/ neurogenic claudication and pelvic girdle dysfunction.
406-001: 51 YO obese (BMI of 38.8) diabetic male with collapsed disc space, Grade I spondylolisthesis and partial spina bifida with absence of right L5 lamina.
Variable Pre-op 6 Week 3 Month 6 Month 12 Month
Low Back Pain 68 0 1 0 0
Right Leg Pain 77 0 1 0 0
Left Leg Pain 48 0 1 0 0
Right Hip/Buttock Pain 78 0 1 0 0
Left Hip/Buttock Pain 57 0 1 0 0
Right Thigh Pain 0 0 0 0 0
Left Thigh Pain 0 0 0 0 0
ODI 62 10 0 2 0
Variable Pre-op 6 Week 3 Month 6 Month 12 Month
Low Back Pain 50 20 11 24 0
Right Leg Pain 37 0 1 0 8
Left Leg Pain 11 0 1 0 8
Right Hip/Buttock Pain 89 0 0 0 0
Left Hip/Buttock Pain 18 0 11 0 10
Right Thigh Pain 0 0 0 0 0
Left Thigh Pain 0 0 0 0 0
ODI 38 30 10 24 6
12 mo CT Coronal View
12 mo CT Coronal View
12 mo CT Sagittal View
12 mo CT Sagittal View
Pre-op 12 mo
Duo™ Interbody Fusion SystemClinical Evaluation
TM
Spineology Inc.7800 Third Street North, Suite 600Saint Paul, MN 55128-5455p: 888.377.4633 or 651.256.8533f: 651.256.8505
www.spineology.com
TM
A review of the type and rate of events reported for Spineology Duo Interbody Fusion compared to the Direct/Extreme Lumbar Interbody Fusion (XLIF®) is presented below. The overall incidence of peri-operative events observed in subjects treated with the Spineology Duo Interbody Fusion System is low and compares favorably to the literature. Note the five reoperations for the Duo subjects were due to the presence of foraminal stenosis that required supplemental decompression.
Comparison of Complications Between Direct/XLIF1 and the Spineology Duo Interbody Fusion System
EventDirect/XLIF Spineology Duo
# Patients Incidence (%) # Patients Incidence (%)
Total Events 4260 31.4 115 11.3Transient Sensory Deficit 2160 27.1 4.4
Neurological Deficit2
-- Temporary 2957 9.4 4.4-- Permanent 2525 2.5 0.0
Intra-op Complication3 2181 1.9 0.95
Wound Complication4 1254 0.8 0.0Reoperation 2193 3.74 4.36
Subsidence 1900 10.8 20 0.07
1Comparative analysis performed in accordance with definitions outlined in Joseph et. al. Comparison of complication rates of minimally invasive transforaminal lumbar interbody fusion and lateral lumbar interbody fusion: a systematic review of the literature. Neurosurg Focus 39 (4)E4,2015.2Defined as motor deficit.3Includes durotomies, instrument fractures, anterior longitudinal ligament rupture, abdominal wall paresis, vertebral body fractures, bowel injuries, and vascular injuries.4Wound complication includes superficial and deep infections, seromas, and hematomas.5One iliac vein injury repair that did not result in any neuro deficits.6Five additional surgical interventions for residual foraminal stenosis requiring supplemental decompression. 7Less than 1mm change observed from 6-weeks to 12-months post-op in analysis of subjects with 12-month CT scan imaging available.
® XLIF is a registered trademark of Nuvasive Inc.© Spineology Inc. January 2020 L530 Rev. H DA 731
