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191. Single Balloon vs. Double Balloon Kyphoplasty for Treatment of Osteoporotic Vertebral Compression Fractures
100S
Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S–205S
PURPOSE: To assess the efficacy and safety of L’DISQ based on an intraoperative C-arm fluoroscopic evaluation, temperature measurements, and a postoperative histological study of discs and adjacent vital spinal structures. STUDY DESIGN/SETTING: An experimental efficacy and safety study was conducted on a new navigatable percutaneous disc decompression device (L’DISQ, U&I Ceo., Uijeongbu, Korea) based on an in vitro C-arm fluoroscopic guidance, temperature monitoring and histopathologic studies in human cadaveric lumbar spines. PATIENT SAMPLE: human cadaveric lumbar spines. OUTCOME MEASURES: Intradiscal procedures were performed on six fresh human cadaver spine specimens using the L’DISQ spine wand. Using a standard clinical protocol (posterior-lateral technique), a needle was inserted into the target disc space under fluoroscopic guidance. METHODS: 1) Accurate guidance of the needle tip to the posterior annulus of the disc was achieved by intra-operative C-arm flouroscopy. 2) Thermocouple probes were positioned at the segmental nerve and the posterior longitudinal ligament (PLL) of human cadaveric discs. Temperatures were recorded continuously during the procedure. Temperatures were also recorded at various distances from the wand tip in the nucleus pulposus and annulus fibrosus during the procedure. 3) Light microscopic evaluation was performed to examine the histology of the intervertebral disc and neural tissues (T12-Sacrum) from treated spinal segments. RESULTS: 1) Using intermittent C-arm fluoroscopy, the tip of wand can be guided to the posterolateral or posterocentral annulus. 2) The temperature did not exceed 13.2560.84 (?degrees) above initial temperature at any location, indicating that denaturation of adjacent neural tissue did not occur. 3) Histopathologic examination demonstrated decompression of the nucleus pulposus without thermal damage to the surrounding neural tissues. CONCLUSIONS: We successfully developed a percutaneous disc decompression device with a navigatable tip which can access the posterolateral and posterocentral annulus. Using radiofrequency energy, we achieved volumetric removal of the target disc tissue without overt thermal or structural damage to adjacent neural tissues. Further clinical studies are needed to confirm the safety and effectiveness of this promising technology. FDA DEVICE/DRUG STATUS: L’DISQ: Approved for this indication. doi: 10.1016/j.spinee.2009.08.231
191. Single Balloon vs. Double Balloon Kyphoplasty for Treatment of Osteoporotic Vertebral Compression Fractures Jun Zou, MD1, Huilin Yang, MD, PhD2, Stanley Lee, MD3; 1Suzhou, Jiangsu, China; 2The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China; 3University of Michigan, Jackson, MI, USA BACKGROUND CONTEXT: Kyphoplasty allows for balloon reduction of vertebral collapse and is traditionally performed by inserting two balloons, one into each pedicle. The balloons are then simultaneously inflated in order to ensure uniform endplate elevation and vertebral height restoration. However, kyphoplasty can also be performed by using a single balloon that is first inserted on one side, inflated and deflated and then inserted into the contralateral side, inflated and deflated. PURPOSE: The aim of our study is to compare the clinical and radiographic results of a single balloon, sequential kyphoplasty via bipedicular approach versus a traditional two balloon, simultaneous kyphoplasty. STUDY DESIGN/SETTING: A retrospective case controlled study. PATIENT SAMPLE: A total of 38 patients underwent single balloon, sequential kyphoplasty via bipedicular approach from May 2005 to May 2006. During that time 62 patients underwent two balloon, simultaneous kyphoplasty. OUTCOME MEASURES: Radiographic outcome was assessed by the mean change in anterior and middle vertebral body height, and Cobb angle.
Clinical outcome was assessed by change in Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) from preoperatively to postoperatively and at 3, 6, 12 and 18 month follow up. METHODS: 38 patients were treated with single-balloon kyphoplasty. Working channels were introduced into each pedicle simultaneously under fluoroscopy. A single balloon was used to perform balloon kyphoplasty on one side followed by the other. Cement was then injected simultaneously into both working channels. 62 patients underwent double balloon kyphoplaty. Working channels were simultaneously introduced into each pedicle under fluoroscopy. A balloon was introduced in each working channel. The two balloons were simultaneously inflated under fluoroscopy. Cement was then injected simultaneously into both working channels. RESULTS: Significant improvement on the VAS and ODI of all patients was noted between pre-operatively and final follow-up. The change in vertebral height and segmental Cobb angle of both groups also improved. In the single balloon group, the mean height restoration was 76.2; and the mean correction of segmental kyphosis was 9.7 degree. In the double-balloon group the mean height restoration was 63.2 and the mean correction of kyphosis was 8.2. There was no significant difference between two groups. CONCLUSIONS: A single balloon sequential kyphoplasty is an equally effective and safe alternative when compared with the traditional double balloon simultaneous kyphoplasty. By using only one balloon instead of two, equipment cost can be reduced without compromising outcomes. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2009.08.232
192. Evaluation of Leakage Rates for a Cement Directing Kyphoplasty System Robert Pflugmacher, MD1, Johannes Hierholzer, MD2, Gerd Stender, MD3, Renate Hammerstingl, MD4, Eeric Truumees, MD5, Ajay Wakhloo, MD6, Matthew Gounis, PhD6, Thomas Vogl, MD4; 1Charite Universitatsmedizin Berlin, Berlin, Germany; 2Klinikum Ernst-von Bergmann GmbH, Potsdam, Germany; 3Paracelsus-Klinik der Stadt Marl, Marl, Germany; 4Klinikum der Johann Wolfgang Goethe-Universitat Frankfurt, Frankfurt, Germany; 5William Beaumont Hospital, Southfield, MI, USA; 6University of Massachusetts Medical School, Worcester, MA, USA BACKGROUND CONTEXT: Polymethylmethacrylate (PMMA) leakage is a frequent and potentially serious complication of vertebroplasty and kyphoplasty. These leaks can cause compression of neurologic structures or pulmonary embolus. Reported leakage rates are highly variable, ranging from 7 to 90% for vertebroplasty and 0 to 33% for kyphoplasty (Hulme et al., Spine 2006, 31(17):1983). High resolution CT, as compared to radiographs, improves leak detection and higher leak rates are subsequently reported. PURPOSE: To reduce the incidence of leakage, particularly in the posterior aspect, a percutaneous device designed to partially contain and direct PMMA flow was developed. Cement leakage was evaluated and compared for the cement directing kyphoplasty system (CDKS) and traditional vertebroplasty (control) in the treatment of osteoporotic vertebral compression fractures. STUDY DESIGN/SETTING: A multi-center prospective, 2:1 randomized controlled study was conducted. PATIENT SAMPLE: The patient population consisted of adults O 50 years old with osteoporosis and painful vertebral compression fractures. A total of 73 patients and 101 levels were treated, 47 patients (62
Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S–205S
PURPOSE: To assess the efficacy and safety of L’DISQ based on an intraoperative C-arm fluoroscopic evaluation, temperature measurements, and a postoperative histological study of discs and adjacent vital spinal structures. STUDY DESIGN/SETTING: An experimental efficacy and safety study was conducted on a new navigatable percutaneous disc decompression device (L’DISQ, U&I Ceo., Uijeongbu, Korea) based on an in vitro C-arm fluoroscopic guidance, temperature monitoring and histopathologic studies in human cadaveric lumbar spines. PATIENT SAMPLE: human cadaveric lumbar spines. OUTCOME MEASURES: Intradiscal procedures were performed on six fresh human cadaver spine specimens using the L’DISQ spine wand. Using a standard clinical protocol (posterior-lateral technique), a needle was inserted into the target disc space under fluoroscopic guidance. METHODS: 1) Accurate guidance of the needle tip to the posterior annulus of the disc was achieved by intra-operative C-arm flouroscopy. 2) Thermocouple probes were positioned at the segmental nerve and the posterior longitudinal ligament (PLL) of human cadaveric discs. Temperatures were recorded continuously during the procedure. Temperatures were also recorded at various distances from the wand tip in the nucleus pulposus and annulus fibrosus during the procedure. 3) Light microscopic evaluation was performed to examine the histology of the intervertebral disc and neural tissues (T12-Sacrum) from treated spinal segments. RESULTS: 1) Using intermittent C-arm fluoroscopy, the tip of wand can be guided to the posterolateral or posterocentral annulus. 2) The temperature did not exceed 13.2560.84 (?degrees) above initial temperature at any location, indicating that denaturation of adjacent neural tissue did not occur. 3) Histopathologic examination demonstrated decompression of the nucleus pulposus without thermal damage to the surrounding neural tissues. CONCLUSIONS: We successfully developed a percutaneous disc decompression device with a navigatable tip which can access the posterolateral and posterocentral annulus. Using radiofrequency energy, we achieved volumetric removal of the target disc tissue without overt thermal or structural damage to adjacent neural tissues. Further clinical studies are needed to confirm the safety and effectiveness of this promising technology. FDA DEVICE/DRUG STATUS: L’DISQ: Approved for this indication. doi: 10.1016/j.spinee.2009.08.231
191. Single Balloon vs. Double Balloon Kyphoplasty for Treatment of Osteoporotic Vertebral Compression Fractures Jun Zou, MD1, Huilin Yang, MD, PhD2, Stanley Lee, MD3; 1Suzhou, Jiangsu, China; 2The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China; 3University of Michigan, Jackson, MI, USA BACKGROUND CONTEXT: Kyphoplasty allows for balloon reduction of vertebral collapse and is traditionally performed by inserting two balloons, one into each pedicle. The balloons are then simultaneously inflated in order to ensure uniform endplate elevation and vertebral height restoration. However, kyphoplasty can also be performed by using a single balloon that is first inserted on one side, inflated and deflated and then inserted into the contralateral side, inflated and deflated. PURPOSE: The aim of our study is to compare the clinical and radiographic results of a single balloon, sequential kyphoplasty via bipedicular approach versus a traditional two balloon, simultaneous kyphoplasty. STUDY DESIGN/SETTING: A retrospective case controlled study. PATIENT SAMPLE: A total of 38 patients underwent single balloon, sequential kyphoplasty via bipedicular approach from May 2005 to May 2006. During that time 62 patients underwent two balloon, simultaneous kyphoplasty. OUTCOME MEASURES: Radiographic outcome was assessed by the mean change in anterior and middle vertebral body height, and Cobb angle.
Clinical outcome was assessed by change in Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) from preoperatively to postoperatively and at 3, 6, 12 and 18 month follow up. METHODS: 38 patients were treated with single-balloon kyphoplasty. Working channels were introduced into each pedicle simultaneously under fluoroscopy. A single balloon was used to perform balloon kyphoplasty on one side followed by the other. Cement was then injected simultaneously into both working channels. 62 patients underwent double balloon kyphoplaty. Working channels were simultaneously introduced into each pedicle under fluoroscopy. A balloon was introduced in each working channel. The two balloons were simultaneously inflated under fluoroscopy. Cement was then injected simultaneously into both working channels. RESULTS: Significant improvement on the VAS and ODI of all patients was noted between pre-operatively and final follow-up. The change in vertebral height and segmental Cobb angle of both groups also improved. In the single balloon group, the mean height restoration was 76.2; and the mean correction of segmental kyphosis was 9.7 degree. In the double-balloon group the mean height restoration was 63.2 and the mean correction of kyphosis was 8.2. There was no significant difference between two groups. CONCLUSIONS: A single balloon sequential kyphoplasty is an equally effective and safe alternative when compared with the traditional double balloon simultaneous kyphoplasty. By using only one balloon instead of two, equipment cost can be reduced without compromising outcomes. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2009.08.232
192. Evaluation of Leakage Rates for a Cement Directing Kyphoplasty System Robert Pflugmacher, MD1, Johannes Hierholzer, MD2, Gerd Stender, MD3, Renate Hammerstingl, MD4, Eeric Truumees, MD5, Ajay Wakhloo, MD6, Matthew Gounis, PhD6, Thomas Vogl, MD4; 1Charite Universitatsmedizin Berlin, Berlin, Germany; 2Klinikum Ernst-von Bergmann GmbH, Potsdam, Germany; 3Paracelsus-Klinik der Stadt Marl, Marl, Germany; 4Klinikum der Johann Wolfgang Goethe-Universitat Frankfurt, Frankfurt, Germany; 5William Beaumont Hospital, Southfield, MI, USA; 6University of Massachusetts Medical School, Worcester, MA, USA BACKGROUND CONTEXT: Polymethylmethacrylate (PMMA) leakage is a frequent and potentially serious complication of vertebroplasty and kyphoplasty. These leaks can cause compression of neurologic structures or pulmonary embolus. Reported leakage rates are highly variable, ranging from 7 to 90% for vertebroplasty and 0 to 33% for kyphoplasty (Hulme et al., Spine 2006, 31(17):1983). High resolution CT, as compared to radiographs, improves leak detection and higher leak rates are subsequently reported. PURPOSE: To reduce the incidence of leakage, particularly in the posterior aspect, a percutaneous device designed to partially contain and direct PMMA flow was developed. Cement leakage was evaluated and compared for the cement directing kyphoplasty system (CDKS) and traditional vertebroplasty (control) in the treatment of osteoporotic vertebral compression fractures. STUDY DESIGN/SETTING: A multi-center prospective, 2:1 randomized controlled study was conducted. PATIENT SAMPLE: The patient population consisted of adults O 50 years old with osteoporosis and painful vertebral compression fractures. A total of 73 patients and 101 levels were treated, 47 patients (62