44. Prospective outcome evaluation of total disc replacement: a 12- to 24-month follow-up study

44. Prospective outcome evaluation of total disc replacement: a 12- to 24-month follow-up study

Proceedings of the NASS 18th Annual Meeting / The Spine Journal 3 (2003) 67S–171S disc angle, ROM, facet angle, degrees of disc degeneration on MRI we...

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Proceedings of the NASS 18th Annual Meeting / The Spine Journal 3 (2003) 67S–171S disc angle, ROM, facet angle, degrees of disc degeneration on MRI were selected as independent variables. RESULTS: The average follow-up was 7 years ranging from 5 to 9 years. Despite overall clinical results were acceptable, recurrent disc herniation at the same level occurred in 15 patients. From multivariate logistic regression analysis, preoperative % posterior slip at extension (odds ratio [OR]: 6.52 per 5 %, p⬍0.01) and disc angle at flexion (OR: 4.48 per 5 degrees kyphosis, p⬍0.01) were the most important risk factors of the recurrence. In other wards, preoperative retro-listhesis at extension and segmental kyphosis at flexion are most important risk factors of recurrence. Calculated with the multivariate logistic regression model, the high risks of recurrence are preoperative local kyphosis at flexion over 10 degrees and/ or preoperative % posterior slip at extension over 10%. DISCUSSION: Standard discectomy of Love’s procedure provided satisfactory long-term clinical results in surgical treatment of lumbar disc herniation. However, the recurrent lumbar disc herniation occurred in some specific conditions. From this study, it became clear that the most important risk factors were retro-listhesis and segmental kyphosis. According to the statistics, recurrence of lumbar disc herniation can be predicted with preoperative flexion-extension films, furthermore percent posterior slip at extension over 10% and/or segmental kyphosis at flexion over 10 degrees are the limitations of standard discectomy. In such cases, additional spinal fusion should be selected at the first surgery. CONCLUSIONS: Recurrence of lumbar disc herniation can be predicted with preoperative flexion-extension films. Percent posterior slip at extension over 10% or segmental kyphosis at flexion over 10 degrees is the indication for spinal fusion at the first surgery. DISCLOSURES: No disclosures. CONFLICT OF INTEREST: No conflicts.

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There were 34 patients in group I and 52 patients were in group II. There was no statistical difference in pre- and postoperative VAS and Oswestry scores in patients in group II. Fifty patients (96%) had either undergone or were considering a lumbar fusion after IDET. In group I, there was a statistically significant improvement in VAS scores (0.55 points, p=0.05) but no significant improvement in Oswestry scores. Twenty eight (82%) had either undergone or were considering a lumbar fusion after IDET. Fisher exact test demonstrated the proportion of patients in group II who had undergone or were still considering lumbar fusion was significantly greater than the proportion in group I. The value of R was calculated to be 0.23. Thus for IDET to be a costeffective alternative it must achieve a success rate, defined as avoidance of spinal fusion, of no less than 23%. DISCUSSION: Intradiscal electrothermal therapy (IDET) has become increasingly popular as a minimally invasive alternative to spinal fusion for single level discogenic pain. Previous short term studies have demonstrated a favorable success rate for relief of pain but have not focused on long term functional outcomes or overall cost-effectiveness of the procedure. CONCLUSIONS: We found no significant improvement in functional outcomes or pain scores after IDET in patients with any one of the following risk factors: smoking, obesity, age ⬎40 years, multilevel disk disease, and poor confirmation on discography. Ideal candidates showed significant improvement in pain scores but not in functional outcomes. In the ideal candidate using IDET as an initial treatment is of equivocal cost effectiveness. In all other patients, IDET is not cost or clinically effective and should be avoided. DISCLOSURES: Device or drug: IDET. Status: approved. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/S1529-9430(03)00223-7

doi: 10.1016/S1529-9430(03)00222-5 4:01 43. Pain and functional outcomes after intradiscal electrothermal therapy: a retrospective review with cost-effectiveness analysis Nicholas Ahn, MD1,3, Uri Ahn, MD2, Cody Harlan, MD3, Harpreet Basran, MD3, William Reed, MD1, William Hopkins1, Glenn Amundson, MD1; 1Heartland Hand and Spine Orthopaedic Center, Overland Park, KS, USA; 2New Hampshire Spine Institute, Bedford, NH, USA; 3 University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA HYPOTHESIS: The purpose of this study is to determine if pain and functional outcomes are improved after IDET for patients with discogenic low back pain and which groups are most likely to respond. We also performed a cost-effectiveness analysis to determine if IDET presents a large burden to society. METHODS: Eighty-six patients who underwent IDET were prospectively studied over 2 years. Preoperative data was collected and included age, sex, smoking, obesity, workman’s compensation, number of degenerative levels, and discogenic confirmation. Patients were divided into two groups. Patients in group I were ideal candidates. These patients were nonsmokers, not obese, younger than 40, and not on workman’s compensation with single level discogenic disease which was confirmed by discography. group II consisted of all other patients. Visual analog scale (VAS) pain scores and Oswestry functional outcome scores were obtained both before and after the procedure. Paired t-test was used to compare preoperative and postoperative pain scores in both groups. In addition all patients were asked if they had undergone or would still consider a fusion after the IDET. A financial analysis was then performed to calculate R, where R equals the percent success rate IDET must achieve be cost effective: Cost of IDET plus (1-R)(cost of spinal fusion) equals cost of spinal fusion. We assumed surgical treatment for discogenic low back pain consisted of posterior spinal fusion with instrumentation. RESULTS: As a whole, we did not find significant improvement in VAS or Oswestry scores in our cohort. Seventy-eight patients (91%) had either undergone or were considering a lumbar fusion after the procedure.

4:05 44. Prospective outcome evaluation of total disc replacement: a 12to 24-month follow-up study Richard Guyer, MD1, Stephen Hochschuler, MD1, Donna Ohnmeiss, PhD2, Scott Blumenthal, MD1; 1Texas Back Institute, Plano, TX, USA; 2 Texas Health Research Institute, Plano, TX, USA HYPOTHESIS: Total disc replacement in the lumbar spine results in improved pain and self-reported disability evaluated in a prospective study. METHODS: This study is based on the consecutive series of the first 57 patients (26 males, 31 females; mean age 39.9 years) receiving the SB Charite´ (Link) prosthesis at a single center. The study was conducted as part of an FDA approved study to investigate the safety and efficacy of these devices. Indications included symptomatic disc degeneration, failure of at least 6 months of non-operative treatment, and no previous surgery at the operated segment. Data were collected prospectively pre-operatively and at 6 weeks, 3, 6, 12, and 24 months post-operatively (the first 23 patients had reached the 24 month follow-up period at the time data was analyzed for this abstract). Primary outcome measures included Oswestry Low Back Pain Disability Questionnaire, visual analog scale, and SF-36. All procedures were single-level replacements at the L4-5 or L5-S1 level. RESULTS: The mean operative time to perform the disc replacement surgery was 78.7 minutes and the blood loss was 134.3 cc. Operating time and blood loss were significantly less for surgeries at the L5-S1 level than for those at L4-5 (p⬍0.05). The mean pre-operative VAS score was 69.4, which improved to 34.1 at 6 week follow-up (p⬍0.001; paired t-test). This improvement remained stable during the 24 month follow-up (Figure 1). Oswestry disability scores improved 40.1% at the 6 week follow-up (p⬍0.025; paired t-test) with slight continued improvement (to 50.0% of pre-operative values) during the 24 month follow-up (p⬍0.025). SF-36 scores also improved. There were no cases of device failure, displacement, or migration. Complications were comparable to those encountered with anterior interbody fusion. DISCUSSION: The results of this prospective study, using patient selfreport questionnaires, demonstrated significant improvement at 6 weeks

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Proceedings of the NASS 18th Annual Meeting / The Spine Journal 3 (2003) 67S–171S

Fig. 1. Mean VAS pain scores improved significantly by the 6 week followup (p⬍0.01) and improvement was maintained during 24 month follow-up.

and the improvement was maintained during the 24 month follow-up period. The disc prosthesis can be implanted safely, with complications similar to those encountered with anterior lumbar interbody fusion. CONCLUSIONS: Total disc replacement appears to be a viable treatment for symptomatic disc degeneration. DISCLOSURES: Device or drug: Link SB Charite artificial disc. Status: not applicable. CONFLICT OF INTEREST: Richard Guyer, MD, Donna Ohnmeiss, PhD, grant research support: has not directly received any funding, but is affiliated with a non-profit foundation that has received funding to support FDA IDE study. Richard Guyer, MD, Stephen Hochschuler, MD, Scott Blumenthal, MD, other support: has received funding to cover cost of travel to lecture about artificial discs. doi: 10.1016/S1529-9430(03)00224-9

4:09 45. Comparison of ALIF versus 360 fusion for the treatment of lumbar discogenic pain Mitchell Hardenbrook, MD1, Louis Jenis, MD1, Scott Tromanhauser, MD1, Robert Banco, MD1, Brian Agganis1; 1New England Baptist Hospital, Boston, MA, USA HYPOTHESIS: Appropriately selected patients can improve both function and pain with discectomy and fusion for the treatment of lumbar discogenic pain. However, it is unknown whether paients can improve with ALIF alone or is 360 degree fusion required. This study evaluates the early radiographic and clinical outcome of anterior lumbar interbody fusion (ALIF) compared to ALIF plus posterior instrumentation and fusion (360) for the treatment of back pain resulting from single-level or multiple-level degenerative discs. METHODS: Patients who were treated with either ALIF or 360 fusion for discogenic back pain were retrospectively reviewed. All surgeries were performed at the same hospital. Inclusion criteria included pre-operative and at least one-year post-operative SF36, VAS and Oswestry clinical scores and two-year post-operative radiographic imaging. Pre-operative evaluation included radiographs, MRI and discography. Indications for surgery were presence of degenerative disc on MRI with concordant pain on discography in patients who failed non-operative treatment and had no other spine pathology (i.e. spondylolisthesis, nonunion, failed back syndrome). ALIF’s were performed with a cylindrical threaded device and autologous bone graft. 360’s were performed with cortical allograft and autologous bone graft anteriorly and pedicle screw and rod fixation with autologous bone graft posteriorly. Fusion was determined with dynamic flexion-extension radiographs and CT scan. Revision surgery for ALIF nonunion was performed through posterior approach using pedicle screws and rods with autologous bone graft. Revision surgery for 360 was performed through posterior exploration and re-instrumentation with autologous bone graft if nonunion was discovered. If solid union was present, removal of hardware was

performed. Statistical analysis was performed using ANOVA and paired t-test. RESULTS: Fifty-four patients (30 ALIF and 24 360) matched inclusion criteria. 18 patients had one-level fusion and 12 patients had two-level fusion in ALIF group. 5 patients had one-level, 16 patients had two-level and 3 patients had three-level fusion in 360 group. Patients showed a statistically significant improvement post-operatively in all outcomes measured regardless of treatment group compared to pre-surgery (p⬍0.001). Overall, there was no significant difference in clinical outcome comparing ALIF versus 360. However, patients undergoing single level ALIF had an improvement of Oswestry scores compared to 360 fusions (p⫽0.007). No difference was noted in clinical outcomes for 2-level fusions. Six patients in the ALIF (2 one-, 4 two-level) group required revision posterior fusions for nonunion compared to one in the 360 group (three-level). Two additional patients in the 360 group (1 two-,1 three-level) returned to the OR for removal of instrumentation. DISCUSSION: The improvement in Oswestry scores was significantly more in the ALIF group than with 360 fusion for the treatment of one level lumbar discogenic pain. The addition of posterior instrumentation and fusion did not increase the functional outcome in these patients, but decreased the occurence of nonunions requiring an additional surgery. CONCLUSIONS: Fusion surgery for the treatment of discogenic back pain results in statistically significant improvement in clinical outcome measures. Patients treated with ALIF had a better clinical outcome compared to 360 for single level fusions. However, patients treated with ALIF had a higher rate of revision surgery for nonunion. DISCLOSURES: Device or drug: pedicle screws. Status: not approved. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/S1529-9430(03)00225-0

4:13 46. A prospective controlled study of limited versus subtotal posterior discectomy: two-year outcomes in patients with herniated lumbar intervertebral discs and large posterior anular defects Eugene Carragee, MD1, *Steven Paragioudakis, MD2, Todd Alamin, MD1; 1Stanford University, Stanford, CA, USA; 2Private Practice, Shrewsbury, NJ, USA HYPOTHESIS: Large posterior anular defects found at the time of posterior discectomy have been associated with more frequent reherniation when treated by limited discectomy (removing only the extruded or loose intervertebral fragments). A trial of more aggressive discectomy was undertaken to determine of the rate of reherniation could be decreased with this technique. METHODS: Thirty patients with large posterior anular defects encountered during a posterior lumbar discectomy for lumbar disc herniation were treated with an aggressive resection of intervertebral disc material after removal of the extruded or protrused fragment. This group was compared against a historical cohort (46 patients) with large anular defects treated with limited discectomy alone. Reherniation rates and clinical outcomes were determined by independent evaluation at 6, 12, and 24 months after surgery. RESULTS: The reherniation rate in the limited discectomy group was 18% versus 9% in the subtotal discectomy group at followup (p⫽0.09). The back pain (VAS) (p⫽0.2) and Oswestry scores (p⫽0.06) were worse in the subtotal discectomy group at 6, and 12 months follow-up. Time to return to work was longer in the sub-total discectomy group and medication usage was higher at 6 and 12 months. Despite a higher reherniation rate the patient satisfaction a 2 year follow-up was higher in the limited discectomy group. DISCUSSION: Subtotal discectomy is associated with more pain and disability after surgery than limited discectomy alone. The reherniation rate may be better addressed in this subset of patients by some type of anular repair or reconstruction. CONCLUSIONS: More aggressive removal of remaining intervertebral disc material may decrease the risk of reherniation but the overall outcome appears to be less satisfactory especially during the first year after surgery.