Interlaminar Decompression & Stabilization. Reginald Davis, M.D., FAANS, FACS Director of Clinical Research
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1 Interlaminar Decompression & Stabilization Reginald Davis, M.D., FAANS, FACS Director of Clinical Research
2 Disclosures
3 Background Device meant to stabilize the spine without fusion following decompression surgery Preserves motion at the index level and adjacent levels Intended for one or two levels between L1-L5 Moderate to severe stenosis in the lumbar spine should be present Symptoms in legs and buttocks with or without axial pain Contraindications: Prior fusion at the index level Compromised vertebral bodies at the index level Spondylolisthesis greater than or equal to grade II Axial pain only Osteoporosis
4 Design & Target Market
5 Case Study - History 60 year old white female with lumbar spine issues BMI of No previous spine surgeries CHIEF COMPLAINT: States that she has had low back pain for the past 4 months since falling at work on 9/9/14. Pain is constant and is progressively getting worse.
6 Case Study Present Illness Patient has experienced low back pain for 4 months Pain in back, buttocks, groin and posterior leg and lateral calf with numbness/tingling in the left foot Bending, Prolonged Sitting/Standing/Walking and any activity aggravates symptoms Daily activities affected Ice and Medication reduces pain Failed conservative treatments Anti-inflammatory medication, pain management, physical therapy, ESIs Intensity - On a scale of 1-10, with 10 being the worst pain imaginable, the patient reports their average pain level when resting as 2-10, daily as 2-10, when active as 9-10, now as 8-9
7 Case Study Physical Examination Spinal Exam No Scar Deep Tendon Reflexes = Patellar left: 1+. Patellar right: 1+. Achilles left: 2+. Achilles right: 2+. Pedal Pulses = Dorsalis Pedis: 2+. Posterior Tibial: 2+. No LE Edema, no UE Edema No atrophy Heel walk = Left, normal: Right, normal Toe walk = Left, normal: Right, normal Gait = Normal
8 Case Study Physical Examination Continued Spinal Exam Sensory/Palpation Dermatomes Left Lumbar : Normal Right Lumbar : Normal Spinal Tenderness Lumbar : Normal Spinal Exam Range of Motion Lumbar Thoracic : Flexion painful. Hyperextension painful. Lateral Flexion painful: Bilateral. Lateral Flexion limited: Bilateral. Rotation painful: Left.
9 Case Study Physical Examination Continued Spinal Exam Provocative Tests Cervical Tests Clonus test Left: negative. Right: negative Hoffman s Test Left: negative. Right: negative Lumbar Tests Babinski s test Left: negative. Right: negative Lasegue s test Left: negative. Right: negative Straight Leg Raise (seated) Left: positive. Right: negative Patrick s Test Left: negative. Right: negative Romberg test Negative Spinal Exam Muscle Strength Lumbar: Hip Abduction normal. Hip Adduction normal. Knee Flexion normal. Knee Extension normal. Gastrocnemius normal. Tibialis Anterior normal. Peroneals normal. Extensor Hallucis Longus normal
10 Case Study Imaging Dictation L4/5: Degenerative Disc Disease, Bulging Disc, Annular Tear/HIZ, Spinal Stenosis, Foraminal Stenosis, Lateral Recess Stenosis, Facet Degen/Hypertrophy, Osteophytes, Spondylolisthesis. L5/S1: Degenerative Disc Disease, Bulging Disc, Annular Tear/HIZ, Foraminal Stenosis, Facet Degen/Hypertrophy, Osteophytes.
11 Case Study Preoperative Images
12 Case Study Surgery Lumbar Laminotomies with Bilateral Foraminotomies, L4-5. L4-5 Posterior Spinal Instrumentation (Coflex). Surgery Time: 1hr, 1min Estimated Blood Loss: 320mL Complications: None
13 Case Study Postoperative Images
14 Pain Scale Disability Case Study Outcomes VAS ODI Preoperative Interval 1 3 Months Postoperative Preoperative Interval 2 3 Months Postoperative - The patient returned to their usual occupation in less than one month
15 Industry Coflex Study Decompression and Coflex vs. Decompression and fusion Multicenter, prospective randomized (2:1) trial at 21 US sites Coflex N=215 and Fusion N=107 Clinical outcomes measures collected at baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months postoperatively Oswestry Disability Index Short-Form 12 Zurich Claudication Questionnaire Visual Analog Scale Back and leg Davis, R. J., Errico, T. J., Bae, H., & Auerbach, J. D. (2013). Decompression and coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis. SPINE, 38 (18),
16 Inclusion and Exclusion Criteria Davis, R. J., Errico, T. J., Bae, H., & Auerbach, J. D. (2013). Decompression and coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis. SPINE, 38 (18),
17 Operative Details Davis, R. J., Errico, T. J., Bae, H., & Auerbach, J. D. (2013). Decompression and coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis. SPINE, 38 (18),
18 Outcomes Davis, R. J., Errico, T. J., Bae, H., & Auerbach, J. D. (2013). Decompression and coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis. SPINE, 38 (18),
19 Outcomes Continued Davis, R. J., Errico, T. J., Bae, H., & Auerbach, J. D. (2013). Decompression and coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis. SPINE, 38 (18),
20 Outcomes Continued Davis, R. J., Errico, T. J., Bae, H., & Auerbach, J. D. (2013). Decompression and coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis. SPINE, 38 (18),
21 Study Conclusions Davis, R. J., Errico, T. J., Bae, H., & Auerbach, J. D. (2013). Decompression and coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis. SPINE, 38 (18),
22 LSI Coflex Study Materials & Methods Retrospective review of prospectively collected outcomes Data was collected on 59 patients who underwent a minimally invasive decompression via laminotomy and foraminotomy and stabilization using Coflex between June, 2013 and July, 2016 Follow up ranges from 3 months to 3 years Average follow up was 241 days Questionnaires (preoperative and postoperative) Visual Analog Scale (VAS) Self-reported pain with a possible score ranging from 0-10 Oswestry Disability Index (ODI) Self-reported disability with a possible score ranging from 0-50 Return to Work (RTW) Self-reported interval at which the patient returned to their usual occupation
23 Pain Scale LSI Coflex Study VAS VAS Measure N Mean Std. Dev. P-Value VAS Preoperative Postoperative <.001* Preoperative Interval Postoperative *Calculated using Student t-test in Stata
24 Disability LSI Coflex Study ODI 50 ODI Measure N Mean Std. Dev. P-Value ODI Preoperative Postoperative <.001* Preoperative Interval Postoperative *Calculated using Student t-test in Stata
25 LSI Coflex Study RTW 37 patients were used in the return to work analysis 57 patients responded; 20 were removed for indicating retired or homemaker 31 (83.8%) patients reported returning to their usual occupation at follow up 27 (73%) patients returned within 3 months 11 (29.7%) patients returned in less than one month
26 Conclusion Industry studies coupled with LSI s outcomes suggest that decompression with Coflex for the treatment of lumbar spinal stenosis and sponylolisthesis (up to grade I) is a safe an effective alternative to lumbar fusion Recent findings also suggest that it is feasible to perform a decompression with Coflex in an ambulatory surgery center
27
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