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6:06 193. Complications of lumbar artificial disc replacement vs. fusion results from the randomized multicenter FDA IDE Study of the Charité Artificial Disc
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Proceedings of the NASS 20th Annual Meeting / The Spine Journal 5 (2005) 1S–189S
6:06 193. Complications of lumbar artificial disc replacement vs. fusion results from the randomized multicenter FDA IDE Study of the Charite´ Artificial Disc Richard T. Holt, MD1, Mohammed Majd, MD1, Jorge Isaza, MD2, Scott Blumenthal, MD3, Paul McAfee, MD4, Richard Guyer, MD3, Stephen Hochschuler, MD3, Fred Geisler, MD, PhD5, Rolando Garcia, Jr., MD, MPH6, John Regan, MD7; 1Spine Surgery, PSC, Louisville, KY, USA; 2Louisiana Orthopedic Institute, Baton Rouge, LA, USA; 3Texas Back Institute, Plano, TX, USA; 4Spine and Scoliosis Center, Towson, MD, USA; 5Ilinois Neuro-Spine Center, Aurora, IL, USA; 6Orthopedic Care & Sports Medicine Center, Aventura, FL, USA; 7Cedars-Sinai Institute for Spinal Disorders, Los Angeles, CA, USA BACKGROUND CONTEXT: Prior reports of lumbar total disc replacement (TDR) have described significant complications. The FDA IDE study of the CHARITE´ Artificial Disc represents the first Level I data comparison of TDR to fusion. PURPOSE: To report the complications experienced by patients enrolled in the IDE study of the CHARITE´ Artificial Disc. STUDY DESIGN/SETTING: A prospective, randomized, multi-center, FDA-regulated Investigational Device Exemption clinical trial. PATIENT SAMPLE: A total of 304 patients enrolled in the IDE study of the CHARITE´ Artificial Disc. OUTCOME MEASURES: Complications were recorded on adverse event case report forms, reported to the study sponsor and verified through study monitoring. METHODS: Patients were randomized in a 2:1 ratio with 205 patients in the CHARITE´ group and 99 patients in the control group (ALIF with BAK cages). Inclusion criteria included confirmed single-level DDD from L4S1, and failure of nonoperative treatment for at least 6 months. Clinical and Radiographic data were collected pre- and peri-operatively, at 6 weeks, and at 3, 6, 12, and 24 months following surgery. Complications in both groups were recorded throughout the entire study. Complications were reported throughout the study. RESULTS: The overall reported complication rate was equivalent between the two groups. Approach-related complications were slightly higher in the TDR group (9.3% vs. 8.1%). Neurological complications were slightly higher in the control group (17.2% vs. 16.1%). The incidence of superficial wound infection was higher in the TDR group (6.3% vs. 2.0%), but there were no device-related or deep wound infections in either group. The incidence of retrograde ejaculation was 1.5% in the TDR group and 3.0% in the control group. Postoperative ileus presented in 0.5% of the TDR group and 1.0% of the control group. Additional surgery at the operative level was performed in 5.4% of the TDR group and 8.1% of the control group. In the control group, the pseudarthrosis rate was 9.1%, and the rate of reported bone graft site pain was 18.2%. There were no catastrophic TDR device failures, and no cases of osteolysis. There were 7 (3.4%) devicerelated complications in the TDR group with 2 requiring removal. CONCLUSIONS: The complication rate of TDR with the CHARITE´ Artificial Disc is similar to that of ALIF in properly indicated patients. Training, experience, proper sizing and positioning of the prosthesis, and avoidance of overdistraction of the disc space will minimize complications. DISCLOSURES: FDA device/drug: CHARITE Artificial Disc. Status: Approved for this indication. FDA device/drug: BAK Cage. Status: Approved for this indication. CONFLICT OF INTEREST: Author (JG) Other: employee, DePuy Spine; Authors (RTH, MM, JI, SB, PM, RG, SH, FG, JR) Consultant: DePuy Spine; Authors (RTH, SB, PM, RG, FG, JR) Speaker’s Bureau Member: DePuy Spine; Authors (RTH, MM, JI, SB, PM, RG, SH, FG, JR) Grant Research Support: DePuy Spine. doi: 10.1016/j.spinee.2005.05.196 6:12 194. Influence of spacer position on sagittal alignment in instrumented transforaminal lumbar interbody fusion
Howard Goodman, MD, Frank Schwab, MD, Matas Petracchi, Reid Boyce, MD, Jean-Pierre Farcy, MD; Maimonides Medical Center, Brooklyn, NY, USA BACKGROUND CONTEXT: A single-stage circumferential fusion via a posterior approach can be performed via two techniques, a posterior lumbar interbody fusion (PLIF) or a transforaminal lumbar interbody fusion (TLIF). TLIF is gaining popularity because minimal retraction on the nerve roots and dural sac is required to access the disc. To achieve sagittal balance segmental lumbar lordosis has to be preserved or acquired. To our knowledge there have been no published reports assessing the impact of the spacer position on sagittal alignment in TLIF procedures. PURPOSE: Having developed and validated a classification system for describing the final placement of the interbody graft, the next step was to examine the clinical significance. Without any published reports of the impact of spacer placement, this new classification system allows a systematic way of analyzing spacer placement and outcome criteria. The purpose of this study was to evaluate radiologically a correlation between the spacer position in the interbody space and the segmental lordosis. STUDY DESIGN/SETTING: 65 patients who underwent TLIF had preoperative and postoperative X-rays classified according to the new system. It was felt that a good outcome of the procedure would be change in lordosis of the instrumented segment. For that reason, the preoperative and postoperative radiographs were measured for change in lordosis and then this difference was compared with final graft placement. PATIENT SAMPLE: This study encompasses 65 patients with 77 levels instrumented. Most of the patients had indications including spondylolisthesis, spondylolysis, and degeneration with instability. OUTCOME MEASURES: The outcome measures used are the new classification system and the immediate change in lordosis of the instrumented segment. METHODS: This is a retrospective review of 77 levels in 65 patients who underwent a TLIF. There was 1 fused segment at L2–L3, 4 at L3–L4, 44 at L4–L5 and 28 at L5–S1. An independent observer radiographically analyzed the preoperative and immediate postoperative studies. Spacer position was classified from anterior to posterior, medial to lateral as well as obliquity with respect to the end plates. Difference in segmental lordosis was correlated with the spacer position. RESULTS: The analysis of the data showed that the more anterior the graft, the more lordosis was gained. In the five groups starting from the most posterior to the most anterior, the average postoperative change in lordosis varied from zero to 6 degrees, with a direct relationship to how anterior the position of the graft. This relationship had a correlation coefficient of .96, with regression on the line created having an r-squared value of .93. CONCLUSIONS: While only addressing immediate postoperative change in lordosis, the data show a compelling correlation between the degree of anterior graft placement with the amount of final lordosis achieved. Future directions include more numbers, long-term change in lordosis, and subjective patient outcomes. DISCLOSURES: No disclosures. CONFLICT OF INTEREST: Author (JF, FS) Consultant: Medtronic Sofamor Danek. doi: 10.1016/j.spinee.2005.05.197
6:18 195. Spine surgery operative positioning affects risk factors for compartment syndrome: leg intramuscular pressure, blood pressure, and applied load Bryan Leek, Robert Scott Meyer, MD, John Wiemann, Adnan Cutuk, MD, Brandon Macias, Alan Hargens, PhD; University of California, San Diego, CA, USA BACKGROUND CONTEXT: Acute compartment syndrome of the leg is an underreported complication during spine surgery using the 90/90 kneeling frame.
Proceedings of the NASS 20th Annual Meeting / The Spine Journal 5 (2005) 1S–189S
6:06 193. Complications of lumbar artificial disc replacement vs. fusion results from the randomized multicenter FDA IDE Study of the Charite´ Artificial Disc Richard T. Holt, MD1, Mohammed Majd, MD1, Jorge Isaza, MD2, Scott Blumenthal, MD3, Paul McAfee, MD4, Richard Guyer, MD3, Stephen Hochschuler, MD3, Fred Geisler, MD, PhD5, Rolando Garcia, Jr., MD, MPH6, John Regan, MD7; 1Spine Surgery, PSC, Louisville, KY, USA; 2Louisiana Orthopedic Institute, Baton Rouge, LA, USA; 3Texas Back Institute, Plano, TX, USA; 4Spine and Scoliosis Center, Towson, MD, USA; 5Ilinois Neuro-Spine Center, Aurora, IL, USA; 6Orthopedic Care & Sports Medicine Center, Aventura, FL, USA; 7Cedars-Sinai Institute for Spinal Disorders, Los Angeles, CA, USA BACKGROUND CONTEXT: Prior reports of lumbar total disc replacement (TDR) have described significant complications. The FDA IDE study of the CHARITE´ Artificial Disc represents the first Level I data comparison of TDR to fusion. PURPOSE: To report the complications experienced by patients enrolled in the IDE study of the CHARITE´ Artificial Disc. STUDY DESIGN/SETTING: A prospective, randomized, multi-center, FDA-regulated Investigational Device Exemption clinical trial. PATIENT SAMPLE: A total of 304 patients enrolled in the IDE study of the CHARITE´ Artificial Disc. OUTCOME MEASURES: Complications were recorded on adverse event case report forms, reported to the study sponsor and verified through study monitoring. METHODS: Patients were randomized in a 2:1 ratio with 205 patients in the CHARITE´ group and 99 patients in the control group (ALIF with BAK cages). Inclusion criteria included confirmed single-level DDD from L4S1, and failure of nonoperative treatment for at least 6 months. Clinical and Radiographic data were collected pre- and peri-operatively, at 6 weeks, and at 3, 6, 12, and 24 months following surgery. Complications in both groups were recorded throughout the entire study. Complications were reported throughout the study. RESULTS: The overall reported complication rate was equivalent between the two groups. Approach-related complications were slightly higher in the TDR group (9.3% vs. 8.1%). Neurological complications were slightly higher in the control group (17.2% vs. 16.1%). The incidence of superficial wound infection was higher in the TDR group (6.3% vs. 2.0%), but there were no device-related or deep wound infections in either group. The incidence of retrograde ejaculation was 1.5% in the TDR group and 3.0% in the control group. Postoperative ileus presented in 0.5% of the TDR group and 1.0% of the control group. Additional surgery at the operative level was performed in 5.4% of the TDR group and 8.1% of the control group. In the control group, the pseudarthrosis rate was 9.1%, and the rate of reported bone graft site pain was 18.2%. There were no catastrophic TDR device failures, and no cases of osteolysis. There were 7 (3.4%) devicerelated complications in the TDR group with 2 requiring removal. CONCLUSIONS: The complication rate of TDR with the CHARITE´ Artificial Disc is similar to that of ALIF in properly indicated patients. Training, experience, proper sizing and positioning of the prosthesis, and avoidance of overdistraction of the disc space will minimize complications. DISCLOSURES: FDA device/drug: CHARITE Artificial Disc. Status: Approved for this indication. FDA device/drug: BAK Cage. Status: Approved for this indication. CONFLICT OF INTEREST: Author (JG) Other: employee, DePuy Spine; Authors (RTH, MM, JI, SB, PM, RG, SH, FG, JR) Consultant: DePuy Spine; Authors (RTH, SB, PM, RG, FG, JR) Speaker’s Bureau Member: DePuy Spine; Authors (RTH, MM, JI, SB, PM, RG, SH, FG, JR) Grant Research Support: DePuy Spine. doi: 10.1016/j.spinee.2005.05.196 6:12 194. Influence of spacer position on sagittal alignment in instrumented transforaminal lumbar interbody fusion
Howard Goodman, MD, Frank Schwab, MD, Matas Petracchi, Reid Boyce, MD, Jean-Pierre Farcy, MD; Maimonides Medical Center, Brooklyn, NY, USA BACKGROUND CONTEXT: A single-stage circumferential fusion via a posterior approach can be performed via two techniques, a posterior lumbar interbody fusion (PLIF) or a transforaminal lumbar interbody fusion (TLIF). TLIF is gaining popularity because minimal retraction on the nerve roots and dural sac is required to access the disc. To achieve sagittal balance segmental lumbar lordosis has to be preserved or acquired. To our knowledge there have been no published reports assessing the impact of the spacer position on sagittal alignment in TLIF procedures. PURPOSE: Having developed and validated a classification system for describing the final placement of the interbody graft, the next step was to examine the clinical significance. Without any published reports of the impact of spacer placement, this new classification system allows a systematic way of analyzing spacer placement and outcome criteria. The purpose of this study was to evaluate radiologically a correlation between the spacer position in the interbody space and the segmental lordosis. STUDY DESIGN/SETTING: 65 patients who underwent TLIF had preoperative and postoperative X-rays classified according to the new system. It was felt that a good outcome of the procedure would be change in lordosis of the instrumented segment. For that reason, the preoperative and postoperative radiographs were measured for change in lordosis and then this difference was compared with final graft placement. PATIENT SAMPLE: This study encompasses 65 patients with 77 levels instrumented. Most of the patients had indications including spondylolisthesis, spondylolysis, and degeneration with instability. OUTCOME MEASURES: The outcome measures used are the new classification system and the immediate change in lordosis of the instrumented segment. METHODS: This is a retrospective review of 77 levels in 65 patients who underwent a TLIF. There was 1 fused segment at L2–L3, 4 at L3–L4, 44 at L4–L5 and 28 at L5–S1. An independent observer radiographically analyzed the preoperative and immediate postoperative studies. Spacer position was classified from anterior to posterior, medial to lateral as well as obliquity with respect to the end plates. Difference in segmental lordosis was correlated with the spacer position. RESULTS: The analysis of the data showed that the more anterior the graft, the more lordosis was gained. In the five groups starting from the most posterior to the most anterior, the average postoperative change in lordosis varied from zero to 6 degrees, with a direct relationship to how anterior the position of the graft. This relationship had a correlation coefficient of .96, with regression on the line created having an r-squared value of .93. CONCLUSIONS: While only addressing immediate postoperative change in lordosis, the data show a compelling correlation between the degree of anterior graft placement with the amount of final lordosis achieved. Future directions include more numbers, long-term change in lordosis, and subjective patient outcomes. DISCLOSURES: No disclosures. CONFLICT OF INTEREST: Author (JF, FS) Consultant: Medtronic Sofamor Danek. doi: 10.1016/j.spinee.2005.05.197
6:18 195. Spine surgery operative positioning affects risk factors for compartment syndrome: leg intramuscular pressure, blood pressure, and applied load Bryan Leek, Robert Scott Meyer, MD, John Wiemann, Adnan Cutuk, MD, Brandon Macias, Alan Hargens, PhD; University of California, San Diego, CA, USA BACKGROUND CONTEXT: Acute compartment syndrome of the leg is an underreported complication during spine surgery using the 90/90 kneeling frame.