An Innovative, Cost-Effective, Negative Pressure Device for Management of Bedsores in Traumatic Paraplegia

An Innovative, Cost-Effective, Negative Pressure Device for Management of Bedsores in Traumatic Paraplegia

86S Proceedings of the NASS 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S PURPOSE: To assess patients’ clinical and functional outcome a...

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86S

Proceedings of the NASS 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S

PURPOSE: To assess patients’ clinical and functional outcome after MLL. STUDY DESIGN/SETTING: Retrospective review of patients’ hospital and office medical records. PATIENT SAMPLE: 97 consecutive patient with lumbar canal stenosis who underwent MLL. OUTCOME MEASURES: VAS, ODI, SF-12. METHODS: 97 patients underwent bilateral decompression of lumbar stenosis at 172 levels; L1-2 three, L2-3 26, L3-4 52, L4-5 72, L5-S1 19 levels. All patients had symptomatic lumbar spinal canal stenosis and had failed conservative treatment. A unilateral laminotomy was used to decompress the central canal, ipsilateral and contra-lateral subarticular recess under microscope magnification. Peri-operative data and complications were recorded. Spine outcome measures were recorded pre-operatively and at subsequent follow-ups. 12 patients had associated degenerative scoliosis, 43 had listhesis, 4 had adjacent level degeneration next to the previously instrumented fusion levels, and 45 had associated disc herniation requiring microdiscectomy. RESULTS: There were 56 males and 41 females. Mean follow-up was 6.064.6 months (6 weeks-17 months). The values for pre-operative and post-operative outcome scores are given in Table-1. Mean estimated blood loss was 1826131 cc. 85 percent patients had resolution of the leg pain, and 38 percent patients had improvement in back pain. 18 patients had simultaneous non-instrumented fusion and 13 had instrumented fusion. There were six dural tears, one post-operative epidural hematoma requiring surgical evacuation, two post-operative deep infections, and three recurrent disc herniations requiring further decompression. CONCLUSIONS: MLL is a viable option for lumbar decompression, especially in patients with degenerative scoliosis and listhesis. The procedure is technically demanding, however, the complication rate is acceptably low. Posterior osseo-musculo-ligamentous structures are preserved relative to laminectomy. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2010.07.229

Friday, October 8, 2010 4:10–5:10 PM Focused Paper Presentations 3: Cutting Edge

1. A). We compared the fusion rates between the new system and a historical cohort of standalone cage. STUDY DESIGN/SETTING: Prospective clinical study with historical controls. PATIENT SAMPLE: From Jan. 2006 to Sept. 2008, the device was used in one or two-level fusion (from L2-3 to L5-S1) in consecutive 46 patients (mean age, 64.1) with low-grade olistheses (n520), painful disc (n524), and pseudarthrosis (n52); a total of 69 levels were fused and with a mean follow-up (FU) of 15.2 months (mo) (range, 12-30). The historical cohort was of consecutive 52 patients (mean age, 58.2) with identical indications underwent standalone cage between 2004 and 2006, with 72 levels fused, and with a mean FU of 38.4 mo (range, 26–52). Both groups were operated by the same surgeon, using the same approach and cage. OUTCOME MEASURES: Fusion was defined as bridging trabeculae assessed by reformatted CT sagittal images taken at postoperative 12 mo or later (Fig 2. C). Outcome data: VAS score (0 to 10), Roland-Morris questionnaire (RM), and self-rated satisfactory level, were collected every 3 mo for 1 year then every 6 mo thereafter, and analyzed using Student’s t-test. METHODS: After posterior decompression (optional) and graft harvesting, using lateral retroperitoneal access and dissecting the psoas muscle backward, lateral disc was exposed and prepared; bone graft and then a rectangular titanium cage were inserted; a vertical bone cut was made through a slot of the cage, then the plate (a modified cervical plate: 32-mm long, 16-mm wide) was hammered inside the adjacent vertebrae. (Fig 1. B, C) RESULTS: The study group achieved statistically significant (p!0.001) higher fusion rate (94.2%) than the control (81.9%). The preoperative mean VAS and RM scores: 9.13 and 18.58, were improved to 2.33 and 5.43 at final FU (p!0.001). Outcome ratings were: excellent/good: 87% (n540), fair: 8.7%, poor: 4.3% (n52). The mean operating time and blood loss for one and two-level fusion were: 55 and 92 minutes; 120 and 220 cc. There was no major complication, device dislodgement, or vertebral damage by the plate. CONCLUSIONS: The improved fusion rate implies segmental stiffness has been increased by adding the plate. The results support the theory of lateral intravertebral plate. This simple device seems to be a viable fixator for short segment fusion. Fig 1, A: The force vectors of extension (arrow 1), rotation (curved arrow 2), and shear (arrow 3) are perpendicular to the plate and neutralized; lateral bending is resisted by the cage. B, C: Postoperative radiograms. Fig 2, A: 59 years old male with L3-4 pseudarthrosis. B: The defect was filled with 20 cc of autograft and fixed using the new device. C: Reformatted CT sagittal image shows solid union at 18 months follow-up. FDA DEVICE/DRUG STATUS: rectangular titanium lumbar fusion cage, modified titanium anterior cervical plate: Not approved for this indication. doi: 10.1016/j.spinee.2010.07.231

186. Intravertebral Plate and Cage System via Lateral Trajectory for Lumbar Interbody Fusion- A Novel Fixation Device Jin-Fu Lin, MD1, Riccardo Iundusi, MD2, Umberto Tarantino, MD3, Myung-Sang Moon, MD4; 1Dept. of Spinal Surgery, Taipei Hospital, D.O.H., Sin-Chuan, Taiwan; 2Dept. of Orthopedic and Traumatology, University of Rome, ‘‘Tor Vergata’’, Rome, Italy; 3Dept. of Orthopedic and Traumatology, University of Rome, Rome, Italy; 4Dept. of Orthopedic Surgery, Halla General Hospital, Jeju, Republic of Korea

187. An Innovative, Cost-Effective, Negative Pressure Device for Management of Bedsores in Traumatic Paraplegia Rajeshwar N. Srivastava, MD; King Georges Medical College, CSM Medical University, Lucknow, India

BACKGROUND CONTEXT: Lumbar standalone cage has been shown that it may resist intervertebral motions of flexion and lateral bending, but not extension and rotation. A supplemental screw-based fixator is required to obtain stability, but also raises device related issue. Furthermore, the ideal rigidity for fusion is unknown. PURPOSE: To improve stability of standalone cage, we theorized that by adding a laterally implanted intravertebral plate, residual segmental motions might be neutralized and enhance fusion. The theoretical biomechanics was: using the vertebrae as the fulcrums, the plate was parallel to the coronal plane of spinal column, the force vectors of extension, axial rotation, and shear were perpendicular to the plate, and therefore resisted (Fig

BACKGROUND CONTEXT: This study evaluates the effect of negative pressure and its application in bedsore management by an easy to apply negative pressure device. PURPOSE: Management of bedsores in traumatic paraplegia has been a challenge. Conventional serial debridement & daily dressing require prolong hospitalization, newer complications and economic burden. Negative pressure to promote wound healing is under evolution. An innovative method to attain negative pressure in the base of bedsore has been studied for the outcome. STUDY DESIGN/SETTING: A prospective longitudinal interventional study.

All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.

Proceedings of the NASS 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S PATIENT SAMPLE: Spinal cord injury patients admitted in SCI Unit of KG Medical College, Lucknow-India. OUTCOME MEASURES: Size and depth of bedsore, slough and discharge, wound culture and sensitivity, frequency of dressing and cost. METHODS: Negative pressure device (NPD) included sterilized piece of foam, a low power continuous suction apparatus (Romovac) and transparent polyurethane adhesive dressing (Opsite). NPD was exclusively a bedside procedure. Perforated end of drainage tube was placed on wound surface and other exiting 10cms away from wound margin connected to Romovac. Sterilized foam was trimmed to size and geometry of wound as cover. Opsite closed the wound with an airtight seal. The bellow of Romovac charged to attain negative pressure. Recharging was done in 5–6 hrs. Wound inspected and dressing changed every 5–7 days. Fifty patients with moderate to large sacral sores were included. 25 with NPD as cases and 25 by conventional dressing as controls. RESULTS: NPD converts an open wound into close controlled wound. By drawing away fluid from wound it prevents collection, decreases purulence. Negative pressure increases vascularity, enhances granulation, reduces the size and depth of wound. Airtight sealing prevents soiling, minimizes odor. In 3weeks NPD dressing frequency was 4–5, O20 in controls; presence of slough 6.25% vs. 60% in controls; serous, odorless discharge in all (100%) vs. 40% in controls. With NPD Mean decrease in wound area was 13% after 10 days, 33%at 3 weeks. In control 8%,15%. Mean decrease in wound depth 32% at 10 days,98%at 3 weeks. In controls 10% &36%. In NPD 90%wounds were fit for SSG at 3weeks, none in controls. Bacterial culture sterile in 10days, none in controls. CONCLUSIONS: NPD in bedsore management is an OPD procedure, easy to apply, well tolerated with minimal side effects. It reduces the frequency of dressing, hastens recovery, and does not require hospitalization. The device can be self monitored at home with followup in OPD at 2–3 week interval. The NPD apparatus suggested is innovative, cost-effective. FDA DEVICE/DRUG STATUS: ROMOVAC: Not approved for this indication. doi: 10.1016/j.spinee.2010.07.232

188. An RCT between Transforaminal Lumbar Interbody Fusion and Posterolateral Fusion in the Degenerative Lumbar Spine Rune L. Hedlund, MD1, Pavel Neumann, MD1, Christer Johansson1, Kourosh Jalalpour, PhD2; 1Dep. of Orthopedics, Gothenburg, Sweden; 2 CLINTEC, Dep. of Orthopedics, Karolinska Institutet, Stockholm, Sweden BACKGROUND CONTEXT: On theoretical grounds, interbody fusion has been suggested to result in an improved outcome compared with posterolateral fusion (PLF). Data to support this view, however, are scarce. PURPOSE: To determine whether Transforaminal Lumbar Interbody Fusion (TLIF) results in an improved outcome compared to PLF in surgical treatment of the degenerative lumbar spine. STUDY DESIGN/SETTING: A randomized controlled trial. PATIENT SAMPLE: A total of 135 patients, 74 men and 61 women, (age range 25–65 years, mean 45 years) with degenerative disc disease and central disc hernia or post discectomy syndrome. OUTCOME MEASURES: Before surgery and at the 2-year follow-up, pain (VAS) and functional disability were quantified by the Disability Rating Index (DRI, 0–100) and the Oswestry Disability Index (ODI). The global outcome was assessed by the patient as much better, better, unchanged, or worse. METHODS: The patients were randomized to non-instrumented PLF (n567) with iliac bone autograft or TLIF (n568) with pedicle screw fixation. The TLIF was performed with a porous tantalum interbody implant. Autograft was packed in front of the cage and posterolaterally. RESULTS: The 2 year follow-up rate was 98%. Both groups improved significantly from preop to 2 years follow up. At two years follow up

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the TLIF group was significantly better than the PLF group in pain index (27 vs. 40, p50.007) and DRI (25 vs. 36, p50.003). The ODI was non-significantly better in the TLIF group (23 vs. 28, p50.110). Similarly, the percent much better/better was higher in the TLIF group compared to the PLF group (91% vs. 69%, p50.012). The percent much better after TLIF was 63% in the TLIF group and 47% in the PLF group. CONCLUSIONS: The study shows that the outcome of the TLIF procedure in central disc hernia and status post discectomy syndrome is better than that of non-instrumented PLF. The percent much better after TLIF was notably high (63%), compared to PLF (47%) as well as to previous studies. The overall results strongly suggest interbody fusion to be considered a primary choice in the degenerative lumbar spine. FDA DEVICE/DRUG STATUS: Intervertebral fusion cage, TM300: Investigational/Not approved. doi: 10.1016/j.spinee.2010.07.233

189. Motor Segmental Recovery in Spinal Cord Injury - A Blessing in Disguise! Rajeshwar N. Srivastava, MD; King Georges Medical College, CSM Medical University, Lucknow, India BACKGROUND CONTEXT: Management of traumatic paraplegia remains controversial. At one end of the spectrum are the group of extremists who advocate early surgical intervention in all, whilst diametrically opposite are those who insist that conservative management is still the best. There is strong evidence that the majority of patients will make some neurological recovery, although the potential is much greater in those with incomplete injuries. PURPOSE: Our knowledge regarding neurological recovery following spinal cord injury is like a tip of an iceberg. Spinal cord does not regenerate once damaged but nerve roots do so if an optimum environment is provided. Although distal neurological recovery is unlikely in ASIA Impairment Scale A (complete lesions), root recovery at the site of injury can occur. ASIA has recognized Zone of partial preservation & Zonal segmental recovery below the neurological level. Such a recovery in motor functions may make all the difference in final outcome of ambulation & functional status of the patient. STUDY DESIGN/SETTING: A prospective longitudnal study of posterior instrumentation with or without laminectomy in neurological recovery of thoracolumbar spine injury. PATIENT SAMPLE: Acute complete (ASIA A) thoraco lumbar injuries admitted in spinal cord injury unit of KG Medical College, Lucknow. OUTCOME MEASURES: At 2 year follow up; Distal neurological recovery ‘‘DNR’’ (below Zone of PP); Motor segmental recovery ‘‘MSR’’ (in Zone of PP); Ambulation time & Ambulation mode. METHODS: 100 Thoracolumbar injuries in ASIA A underwent surgery. In 60, posterior instrumentation alone (Gp1), and in 40 posterior instrumentation with laminectomy (Gp2) was done. Results of these were compared with randomly picked up 100 similar cases treated conservatively (Gp3). RESULTS: Merits of surgery (Gp1&Gp2) over conservative (Gp3) were many in terms of reduction & stability, pain-function scores, total hospital stay, ambulation mode and time. There was no significant difference in distal neurological recovery of spinal cord in conservative and surgical groups. ASIA A remained ASIA A in 80% in group-I; 77.7% in groupII; 88% in group-III. When ASIA A recovered to ASIA D/E then distal neurological recovery was said to be functional (FDNR). FDNR was almost similar in all three groupsd11.67% in group-I; 12.5% in group-II and 7.0% in Group-III. Motor segmental recovery (MSR) in zone of partial preservation was found to be more in surgical group than conservative group- 68.33% in group-I; 92% in group-II and 40.0% in Group-III. MSR was said to be significant ‘‘MSR-Sig’’ only when at least 2 key

All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.