MIS versus Percutaneous Lumbar Interbody Fusion with OptiMesh® Stéphane Lavoie MD Presented at International Society for the Advancement of Spine Surgery (ISASS) April 30-‐‑May 2, 2014 – Miami, Florida INTRODUCTION An IRB approved, observational, retrospective chart review was conducted at a single center to evaluate patients with symptomatic single-‐‑level lumbar conditions treated with the OptiMesh Graft Containment System* (Spineology Inc., St. Paul, MN) as the interbody fusion device with bilateral pedicle screw fixation. All patients having surgery between 10/2007 through 12/2012, and that had a minimum 6-‐‑mo post-‐‑op visit were invited to participate in the study. After chart review, 98 patients met protocol inclusion criteria. A comparison of outcomes was made between MIS (TLIF or PLIF) and percutaneous techniques for implant of OptiMesh. OptiMesh was filled with AFT bone graft* from MTF (Musculoskeletal Transplant Foundation, Edison, NJ). No BMP, graft extenders, or other biologics were used. The majority of subjects (90.8%; 90/98) had a primary diagnosis of spondylolisthesis or degenerative disc disease (both with stenosis). See Figure 1 for subject demographics. Figure 1: DEMOGRAPHICS Mean ± SD (Median) PERC Min – Max or # (%) (n=46) Gender 19 (41%) Female 27 (59%) Male 63 ± 12 (66) 39 – 84 Age (Years) 29 ± 5 (28) 19 -‐‑ 39 Body Mass Index Treated Level 0 (0%) L1-‐‑L2 0 (0%) L2-‐‑L3 4 (9%) L3-‐‑L4 40 (87%) L4-‐‑L5 2 (4%) L5-‐‑S1 11 ± 5 (10) 6 – 23 Follow-‐‑Up (Months) MIS (n=52) 22 (42%) 30 (58%) 55 ± 10 (54) 37 – 82 p-‐‑value* 29 ± 6 (28) 17 -‐‑ 43 1 (2%) 6 (12%) 4 (8%) 23 (44%) 18 (35%) 26 ± 18 (18) 6 – 76 0.8143 <0.0001 1.000 0.0004 6 mo 12 mo Figure 4 MIS PERC Excellent 31 25 Good 13 13 Satisfactory 7 4 Poor 4 1 66 yr. male, L4-‐‑5 Percutaneous with excellent clinical outcome RESULTS Forty-‐‑six (46) procedures involved percutaneous placement (PERC) of the OptiMesh interbody device and 52 procedures involved an open approach (MIS). Results were notable for statistically significant improvements in clinical utility (see Figure 2) observed for the percutaneous group. Figure 2: CLINICAL UTILITY Mean ± SD (Median) Min – Max or # (%) Estimated Blood Loss (cc) Mean Operating Room Time (mins) Mean Length of Stay / Duration of Hospitalization (Days) FUSION RATES Good fusion rates were observed in both study groups . A high rate (89%) of subjects with x-‐‑rays available at 12-‐‑ months post-‐‑operative were deemed fused as read by an independent radiologist . The exceptions were 1 subject in the MIS group determined not fused and 4 x-‐‑rays that were unreadable (poor quality). Fusion assessments were determined by the presence of bridging bone into the graft pack. 6 mo PERC N=46 107 ± 18 (100) 50 – 150 143 ± 39 (148) 24 -‐‑ 210 1.6 ± 0.9 (1.0) 0 -‐‑ 5 MIS N=52 176 ± 131 (100) 100 – 700 167 ± 37 (158) 60 – 254 2.1 ± 2.0 (1.0) 1 – 13 6 mo p-‐‑valueᵻ 0.0099 0.0062 0.1146 ᵻWilcoxon Rank Sum test. <0.0001 *Fisher’s exact test for categorical variables or Wilcoxon Rank Sum test for continuous variables. 12 mo 2 wk 12 mo Substantially fewer complications were observed in the PERC group (2%; 1/46) when compared to the MIS group (13.5%; 7/52), see Figure 3. Further, while subject satisfaction with the procedure was highly positive for both groups, the observed rate of satisfaction was slightly improved in the PERC group as illustrated in Figure 4. 49 yr. female, L4-‐‑5 Percutaneous with good clinical outcome Figure 3 Approach 53 yr. female, L5-‐‑S1 PLIF with excellent clinical outcome Event Type n MIS-‐‑PLIF Dural Tear 1 MIS-‐‑PLIF Wound Infection 1 MIS-‐‑PLIF Ileus w/Bowel Obstr. 1 MIS-‐‑TLIF Nerve Root Injury 1 MIS-‐‑TLIF Acute Renal Failure 1 MIS-‐‑TLIF Acute Anemia 1 MIS-‐‑TLIF Acute Resp. Distress 1 PERC 1 Acute Resp. Distress CONCLUSION In the author’s practice, OptiMesh implanted via the percutaneous technique, combined with a percutaneous pedicle screw instrumentation, yields good fusion rates and clinical outcomes. *Not FDA cleared for this indication
© Copyright 2024 ExpyDoc
