- Email: [email protected]
48. Clinical Outcomes of Multi-level Lumbar Fusions to L5 versus Multi-level Lumbar Fusions to the Sacrum
24S
Proceedings of the NASS 22nd Annual Meeting / The Spine Journal 7 (2007) 1S–163S
underwent L2-3 ALIF. No patient volunteered experiencing sexual dysfunction after ALIF; however, upon further questioning, 1 patient admitted to diminished (but not absent) genital sensation, which she described as ‘‘minor’’, and 1 woman admitted to diminution in intensity (but not absence) of orgasm, that she described as ‘‘mild’’; both patients had L4-S1 ALIF. All patients denied dyspareunia. CONCLUSIONS: Sexual dysfunction after the anterior approach to the lumbar spine can occur in women, with 6.7% of women reporting some change in sexual function after the surgery. However, all women initially responded that they experienced no change in sexual function, and only 2 of 30 revealed alterations after closer questioning; all indicated that they found these alterations to be relatively modest, and easily tolerated. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2007.07.055
Wednesday, October 24, 2007 5:25–6:25 PM Special Interest Poster Presentation 4: Fusion 48. Clinical Outcomes of Multi-level Lumbar Fusions to L5 versus Multi-level Lumbar Fusions to the Sacrum John Johnson, MD1, Kelly Bratcher, RN2, Steven Glassman, MD3, Leah Carreon, MD, MSC4; 1University of Louisville, Louisville, KY, USA; 2 Leatherman Spine Center, Louisville, KY, USA; 3University of Louisville, KY, USA; 4Louisville, KY, USA BACKGROUND CONTEXT: Controversy still exists as to whether lumbar fusions involving 3 to 6 levels require fusion to the sacrum. Some surgeons argue that the L5-S1 motion segment should be spared, to allow for some motion at the lumbosacral junction. Other surgeons believe that leaving the L5-S1 motion segment unfused, leads to predictable adjacent level degeneration and thus, should be fused whenever fusion extends over 3 to 5 levels. PURPOSE: The purpose of this study is to compare the clinical outcomes, complication and revision rate of patients with multi-level lumbar fusions fused to L5 to patients fused to S1. STUDY DESIGN/SETTING: Retrospective cohort study in a single spine specialty clinic. PATIENT SAMPLE: Patients who underwent posterolateral lumbar fusion involving 3 to 6 levels. OUTCOME MEASURES: MOS SF-36, ODI, back and leg pain numeric rating scales, peri-operative complication rates and revision rates. METHODS: Patients who underwent a posterolateral lumbar fusion involving 3 to 6 levels with at least two year follow-up and available preoperative and two-year post-operative clinical outcome measures were identified. Standard demographic, operative and radiographic data, complication and revision rates were collected from review of charts and medical records. Clinical outcome measures collected included MOS SF-36, ODI, back and leg pain numeric rating scales. RESULTS: There were 27 patients in the L5 group and 19 in the S1 group. There was no statistically significant difference in the age and gender distribution, number of smokers, length of follow-up or diagnosis between the two groups. There was also no statistically significant difference in the operative time, blood loss or length of stay between the two groups. The complication rate was similar in both groups (L5–59.26%, S1–63.16%, p50.999). Four patients in the L5 group required revisions: 2 for nonunion and 2 for L5-S1 segment degeneration. One patient in the S1 group required a revision for L1-L2 segment degeneration, no patient required a revision for nonunion. Patients in both groups demonstrated significant improvements in SF-36 PCS, ODI and back and leg pain NRS (p!0.001) at two year followup compared with pre-operative. Both groups achieved similar improvements in SF-36 PCS, ODI and back and leg pain NRS.
CONCLUSIONS: There is no significant difference in operative time, blood loss, length of stay, complication rate or revision rate for adjacent level degeneration in patients with long lumbar fusions to S1 compared to those fused to L5. Patients fused to either L5 or S1 demonstrated significant improvements in clinical outcomes at two year follow-up compared with pre-operative and achieved similar improvements in SF-36 PCS, ODI and back and leg pain NRS. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2007.07.057
49. Two-year Outcomes of Lumbar Decompression and Uninstrumented Fusion with Iliac Crest Bone Graft: A Multicenter Prospective Study with Independent Assessments Tushar Ch. Patel, MD1, Alexander Vaccaro, MD2, Michael Fehlings, MD, PhD, FRCSC, FACS3, Jeffrey Fischgrund, MD4; 1 Commonwealth Orthopedics and Rehabilitation, Fairfax, VA, USA; 2 Thomas Jefferson University, Philadelphia, PA, USA; 3 University of Toronto, Toronto, Ontario, Canada; 4 William Beaumont Hospital, Royal Oak, MI, Southfield, MI, USA BACKGROUND CONTEXT: Uninstrumented PLF is an important surgical technique for patients that may have contraindications to instrumented fusions due to poor bone quality or general health concerns necessitating minimizing anesthesia time and operative morbidity. PURPOSE: To present 2 year efficacy and safety results from a cohort of patients undergoing uninstrumented posterolateral fusion (PLF) with autogenous iliac crest bone graft (ICBG). STUDY DESIGN/SETTING: : A prospective, randomized, controlled, multicenter pivotal clinical study to compare the safety and clinical and radiographic outcomes of patients randomized in a 2:1 ratio to either BMP-7or ICBG. PATIENT SAMPLE: Patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis undergoing decompression and uninstrumented PLF with ICBG. OUTCOME MEASURES: Fusion success was determined radiographi¨ 5 degrees of angulation, cally using plain films and was defined as ¡U ¨ 3 mm translational movement and evidence of new bone formation. ¡U Clinical success was determined through use of Oswestry Disability Index (ODI) scores (20% improvement from baseline) and lack of a surgical retreatment at the operative level. Safety was primarily assessed by spontaneous adverse event reporting. METHODS: Eighty-six patients were enrolled, underwent uninstrumented PLF with ICBG, and returned for follow-up at 24 clinical sites in the US and Canada. Patients were evaluated postoperatively at 6 weeks, and 3, 6, 9, 12, and 24 months Sixty-seven patients (78%) returned for a 2 year follow-up visit. RESULTS: The mean age was 69 years (std. dev. 8.3) and the male to female ratio was 30:70. Over 90% of the patients had Grade I spondylolisthesis and L4-L5 was the treated level in 86% of the patients. At 24 months, 85.5% of evaluable patients had O20 point ODI improvement. At baseline the mean ODI was 48.8 which decreased to 22.8 at 24 months. Fusion success at 24 months was achieved by 74.6% of patients. Eight patients (9.2%) required additional surgery to add posterior instrumentation within 24 months for lack of fusion, 2 of the 8 patients also had concomitant interbody fusion. Adverse events potentially attributable to ICBG harvest included: anaemia (13 patients, 14.9%) and donor site complications (8 patients, 9.2%). CONCLUSIONS: These data suggest that uninstrumented PLF with ICBG is associated with significant improvements in clinical outcomes with acceptable rates of fusion success. Appropriate patient selection is important as ICBG harvest and uninstrumented PLF expose patients to a higher risk of complications and pseudarthrosis, respectively than uninstrumented PLF with bone graft substitutes.
Proceedings of the NASS 22nd Annual Meeting / The Spine Journal 7 (2007) 1S–163S
underwent L2-3 ALIF. No patient volunteered experiencing sexual dysfunction after ALIF; however, upon further questioning, 1 patient admitted to diminished (but not absent) genital sensation, which she described as ‘‘minor’’, and 1 woman admitted to diminution in intensity (but not absence) of orgasm, that she described as ‘‘mild’’; both patients had L4-S1 ALIF. All patients denied dyspareunia. CONCLUSIONS: Sexual dysfunction after the anterior approach to the lumbar spine can occur in women, with 6.7% of women reporting some change in sexual function after the surgery. However, all women initially responded that they experienced no change in sexual function, and only 2 of 30 revealed alterations after closer questioning; all indicated that they found these alterations to be relatively modest, and easily tolerated. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2007.07.055
Wednesday, October 24, 2007 5:25–6:25 PM Special Interest Poster Presentation 4: Fusion 48. Clinical Outcomes of Multi-level Lumbar Fusions to L5 versus Multi-level Lumbar Fusions to the Sacrum John Johnson, MD1, Kelly Bratcher, RN2, Steven Glassman, MD3, Leah Carreon, MD, MSC4; 1University of Louisville, Louisville, KY, USA; 2 Leatherman Spine Center, Louisville, KY, USA; 3University of Louisville, KY, USA; 4Louisville, KY, USA BACKGROUND CONTEXT: Controversy still exists as to whether lumbar fusions involving 3 to 6 levels require fusion to the sacrum. Some surgeons argue that the L5-S1 motion segment should be spared, to allow for some motion at the lumbosacral junction. Other surgeons believe that leaving the L5-S1 motion segment unfused, leads to predictable adjacent level degeneration and thus, should be fused whenever fusion extends over 3 to 5 levels. PURPOSE: The purpose of this study is to compare the clinical outcomes, complication and revision rate of patients with multi-level lumbar fusions fused to L5 to patients fused to S1. STUDY DESIGN/SETTING: Retrospective cohort study in a single spine specialty clinic. PATIENT SAMPLE: Patients who underwent posterolateral lumbar fusion involving 3 to 6 levels. OUTCOME MEASURES: MOS SF-36, ODI, back and leg pain numeric rating scales, peri-operative complication rates and revision rates. METHODS: Patients who underwent a posterolateral lumbar fusion involving 3 to 6 levels with at least two year follow-up and available preoperative and two-year post-operative clinical outcome measures were identified. Standard demographic, operative and radiographic data, complication and revision rates were collected from review of charts and medical records. Clinical outcome measures collected included MOS SF-36, ODI, back and leg pain numeric rating scales. RESULTS: There were 27 patients in the L5 group and 19 in the S1 group. There was no statistically significant difference in the age and gender distribution, number of smokers, length of follow-up or diagnosis between the two groups. There was also no statistically significant difference in the operative time, blood loss or length of stay between the two groups. The complication rate was similar in both groups (L5–59.26%, S1–63.16%, p50.999). Four patients in the L5 group required revisions: 2 for nonunion and 2 for L5-S1 segment degeneration. One patient in the S1 group required a revision for L1-L2 segment degeneration, no patient required a revision for nonunion. Patients in both groups demonstrated significant improvements in SF-36 PCS, ODI and back and leg pain NRS (p!0.001) at two year followup compared with pre-operative. Both groups achieved similar improvements in SF-36 PCS, ODI and back and leg pain NRS.
CONCLUSIONS: There is no significant difference in operative time, blood loss, length of stay, complication rate or revision rate for adjacent level degeneration in patients with long lumbar fusions to S1 compared to those fused to L5. Patients fused to either L5 or S1 demonstrated significant improvements in clinical outcomes at two year follow-up compared with pre-operative and achieved similar improvements in SF-36 PCS, ODI and back and leg pain NRS. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2007.07.057
49. Two-year Outcomes of Lumbar Decompression and Uninstrumented Fusion with Iliac Crest Bone Graft: A Multicenter Prospective Study with Independent Assessments Tushar Ch. Patel, MD1, Alexander Vaccaro, MD2, Michael Fehlings, MD, PhD, FRCSC, FACS3, Jeffrey Fischgrund, MD4; 1 Commonwealth Orthopedics and Rehabilitation, Fairfax, VA, USA; 2 Thomas Jefferson University, Philadelphia, PA, USA; 3 University of Toronto, Toronto, Ontario, Canada; 4 William Beaumont Hospital, Royal Oak, MI, Southfield, MI, USA BACKGROUND CONTEXT: Uninstrumented PLF is an important surgical technique for patients that may have contraindications to instrumented fusions due to poor bone quality or general health concerns necessitating minimizing anesthesia time and operative morbidity. PURPOSE: To present 2 year efficacy and safety results from a cohort of patients undergoing uninstrumented posterolateral fusion (PLF) with autogenous iliac crest bone graft (ICBG). STUDY DESIGN/SETTING: : A prospective, randomized, controlled, multicenter pivotal clinical study to compare the safety and clinical and radiographic outcomes of patients randomized in a 2:1 ratio to either BMP-7or ICBG. PATIENT SAMPLE: Patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis undergoing decompression and uninstrumented PLF with ICBG. OUTCOME MEASURES: Fusion success was determined radiographi¨ 5 degrees of angulation, cally using plain films and was defined as ¡U ¨ 3 mm translational movement and evidence of new bone formation. ¡U Clinical success was determined through use of Oswestry Disability Index (ODI) scores (20% improvement from baseline) and lack of a surgical retreatment at the operative level. Safety was primarily assessed by spontaneous adverse event reporting. METHODS: Eighty-six patients were enrolled, underwent uninstrumented PLF with ICBG, and returned for follow-up at 24 clinical sites in the US and Canada. Patients were evaluated postoperatively at 6 weeks, and 3, 6, 9, 12, and 24 months Sixty-seven patients (78%) returned for a 2 year follow-up visit. RESULTS: The mean age was 69 years (std. dev. 8.3) and the male to female ratio was 30:70. Over 90% of the patients had Grade I spondylolisthesis and L4-L5 was the treated level in 86% of the patients. At 24 months, 85.5% of evaluable patients had O20 point ODI improvement. At baseline the mean ODI was 48.8 which decreased to 22.8 at 24 months. Fusion success at 24 months was achieved by 74.6% of patients. Eight patients (9.2%) required additional surgery to add posterior instrumentation within 24 months for lack of fusion, 2 of the 8 patients also had concomitant interbody fusion. Adverse events potentially attributable to ICBG harvest included: anaemia (13 patients, 14.9%) and donor site complications (8 patients, 9.2%). CONCLUSIONS: These data suggest that uninstrumented PLF with ICBG is associated with significant improvements in clinical outcomes with acceptable rates of fusion success. Appropriate patient selection is important as ICBG harvest and uninstrumented PLF expose patients to a higher risk of complications and pseudarthrosis, respectively than uninstrumented PLF with bone graft substitutes.