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correlations (r 5 0.29 to 0.59) were found to be statistically significant between the BPI and ODI and performance-based tests at all postoperative time points (corrected p ! .05). For the SF-12 PCS, low-to-moderate correlations were noted with the 5 Chair Stand test at 3 months and all performance-based tests at 6 months (r 5 0.34 to 0.51; corrected p ! .05). The 5 Chair Stand test demonstrated the strongest relationship with the patient-reported measures. CONCLUSIONS: All of the measures significantly improved following surgery, with the patient-reported measures having greater responsiveness than the performance-based tests. Little to no correlation was found between patient-reported and performance-based tests preoperatively and low-to-moderate correlations were noted at all postoperative time points. Results highlight the importance of including both patient-reported outcomes and performance-based measures when evaluating physical recovery after spine surgery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2014.08.135
105. Measure Your Own Medical Outcome Profile (MYMOP): Validation of a Patient Generated Outcome Questionnaire by Comparison to the Roland Morris Disability Questionnaire (RMDQ) Patrick Hourigan, PT1, Andrew Clarke, FRCS1, Sarah L. Whitehouse, PhD2, Helen M. Challinor3; 1Peninsula Spinal Unit, Exeter, UK; 2 Queensland University of Technology, Brisbane, Australia; 3Royal Devon and Exeter NHS Hospital, Exeter, UK BACKGROUND CONTEXT: Demand is increasing for outcome measures after spinal procedures that are sensitive to the patient’s concerns. We have become increasingly dissatisfied with measures such as the Roland Morris Disability Questionnaire that are insensitive to our patients’ needs. PURPOSE: To validate the use of a patient generated questionnaire (Measure Your Own Medical Outcome Profile-MYMOP) in patients receiving trans-foraminal epidural steroid injection (TFESI) for lumbar nerve root pain, secondary to MRI proven disc prolapse. Validity was assessed by comparison to the recognised outcome tooldThe Roland Morris Disability Questionnaire (RMDQ). MYMOP is a simple questionnaire that allows the patient to choose 2 symptoms and a functional activity that matter most to them, and a score for their well-being, for the measurement of outcome after a therapeutic intervention. STUDY DESIGN/SETTING: Prospective, longitudinal study undertaken in a day case surgery unit of a University affiliated teaching hospital. PATIENT SAMPLE: 76 patients at our institution undergoing TFESI as a day case procedure for lumbar nerve root pain, secondary to MRI proven disc prolapse. OUTCOME MEASURES: The Roland Morris Disability Questionnaire (RMDQ), Measure Your Own Medical Outcome Profile (MYMOP). METHODS: 76 consecutive patients receiving TFESI at our institution completed MYMOP and RMDQ questionnaires prior to and 6 weeks after the injection procedure. Data were analysed for criteria and convergent validity, reliability (measured by internal consistency) and responsiveness, ie, the ability to detect true changes in clinical states as measured by standardised response means (SRM). RESULTS: MYMOP was shown to be a valid measurement tool with a significant correlation to RMDQ at both time intervals. Preinjection Spearman’s rho is 0.538, p!0.001. Six-week postinjection Spearman’s rho is 0.849, p!0.001 MYMOP internal consistency was measured by Cronbach’s alpha at 0.673 preinjection and 0.873 post injection. For responsiveness, the SRM value for MYMOP was 1.1211 This shows adequate
responsiveness to change and is better than the SRM for RMDQ, leg pain Visual Analog Scale (VAS) and back pain VAS (1.0469, 0.8858 and 0.4989 respectively). CONCLUSIONS: The MYMOP questionnaire is a valid tool for the evaluation of symptoms of nerve root pain pre and post TFESI. It performs well in comparison to the widely used RMDQ. As a measure of responsiveness to change MYMOP is more sensitive than RMDQ and back and leg pain VAS score. MYMOP allows the patient to choose the outcomes that matter most to them, for example, pain, functional ability or well-being factors and is recommended for use in this group of patients. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2014.08.136
Thursday, November 13, 2014 2:10 – 3:10 p.m. Comparative Effectiveness in Spine Surgery 106. Comparison between Instrumented and Uninstrumented Posterolateral Fusion for Lumbar Spinal Stenosis and Spondylolisthesis Alexander Richter, MD, MS1, Steliois A. Koutsoumbelis, MD2, David A. Essig, MD3, Jeff S. Silber, MD, DC4; 1Manhasset, NY, US; 2Glen Oaks, NY, US; 3Hospital for Special Surgery, New York, NY, US; 4West Harrison, NY, US BACKGROUND CONTEXT: Lumbar spinal stenosis (LSS) is a source of significant morbidity and economic burden with an estimated prevalence of 8%-27%, resulting in over 37,000 Medicare surgeries per year. Often, a concomitant spinal fusion is performed with or without instrumentation. While instrumentation has been shown to generate higher fusion rates, its impact on improved patient reported outcomes is unclear. Furthermore, significant cost is associated with its use as well as an increased rate of complications. PURPOSE: The purpose of this study is to compare outcomes of instrumented or uninstrumented fusions for the treatment of lumbar stenosis with concomitant spondylolisthesis with regards to the reduction of back and leg pain, functional status, medication usage and need for further surgery. STUDY DESIGN/SETTING: A single center follow-up survey study was conducted at a tertiary-care teaching hospital. PATIENT SAMPLE: A single surgeon’s database identified all LSS with spondylolisthesis patients who underwent surgical treatment between 2002 and 2010. Adult patients with ICD 9 codes for lumbar spinal stenosis and spondylolisthesis were included in the analysis. Patients’ under the age of 18, revision surgeries, and those with a less than two-year follow-up period were excluded. OUTCOME MEASURES: Oswestry Disability Index (ODI), VAS for back and leg pain, and medication usage profiles. METHODS: Questionnaires consisting of demographic information, Oswestry Disability Index (ODI), VAS for back and leg pain, and medication usage profiles were mailed to patients meeting inclusion criteria. A second mailing and telephone administration targeted nonrespondents. RESULTS: Of the 243 patients who met the inclusion criteria, 109 responded to the survey. 59 were instrumented fusions and 50 were uninstrumented fusions. Length of follow-up was 6.2 and 6.0 (p50.67) for the instrumented fusion and uninstrumented fusion groups. Age was significantly different in the instrumented fusion and uninstrumented
Refer to onsite Annual Meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosures and FDA device/drug status at time of abstract submission.
Proceedings of the NASS 29th Annual Meeting / The Spine Journal 14 (2014) 1S–183S fusion groups (58.1 and 67.9; p!0.001). There was no significant difference in the pre- or postoperative back or leg pain VAS between the two groups. However, each group demonstrated significant improvements in both back and leg pain VAS. ODI at final follow-up trended to be better in the instrumented fusion group but no significant difference was found. Medication usage was similar between the groups (42.4% in the instrumented fusion group and 48% in the uninstrumented fusion group). CONCLUSIONS: In both the instrumented fusion and uninstrumented fusion groups, there was a significant reduction in both back and leg pain at final follow-up. Less than 5% of patients required further surgery. These results suggest similar outcomes can be achieved with regard to the reduction of back and leg pain with either instrumented or uninstrumented fusions for the treatment of lumbar stenosis with concomitant spondylolisthesis in carefully selected patients. Use of uninstrumented fusions may reduce overall medical costs and complication rates. Further studies are needed to determine which patients may best benefit from the use of instrumentation. FDA DEVICE/DRUG STATUS: Pedicle Screw Instrumentation (Approved for this indication)
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the pre- or postoperative back or leg pain VAS between the two groups. Each group demonstrated significant improvements in both back and leg pain VAS. ODI at final follow-up was significantly better in the laminectomy group. Medication usage was similar between the groups (39.7% in the laminectomy group and 50% in the intraspinous device group). CONCLUSIONS: In both the laminectomy and intraspinous device groups, there was a significant reduction in both back and leg pain at final follow-up. However, laminectomy patients had a significantly better ODI. Four percent of laminectomy patients required further surgery compared to 8% of intraspinous device patients. These results suggest that both procedures lead to reduction of back and leg pain. However, laminectomy appears to result in improved ODI scores and decreased rate of reoperation. Further studies are needed to determine which patients may best benefit from laminectomy versus interspinous device insertion. FDA DEVICE/DRUG STATUS: Interspinous Device (Approved for this indication) http://dx.doi.org/10.1016/j.spinee.2014.08.139
http://dx.doi.org/10.1016/j.spinee.2014.08.138
107. Comparison between Laminectomy and Interspinous Devices for Treatment of Lumbar Spinal Stenosis Alexander Richter, MD, MS1, Steliois A. Koutsoumbelis, MD2, David A. Essig, MD3, Jeff S. Silber, MD, DC4; 1Manhasset, NY, US; 2Glen Oaks, NY, US; 3Hospital for Special Surgery, New York, NY, US; 4West Harrison, NY, US
108. Comparative Effectiveness of Open versus Minimally Invasive Sacroiliac Joint Fusion Charles Gerald T. Ledonio, MD1, David W. Polly, Jr., MD2, Marc Swiontkowski, MD3, John T. Cummings, MD4; 1Minneapolis, MN, US; 2University of Minnesota Physicians, Minneapolis, MN, US; 3 University of Minnesota Department of Orthopaedic Surgery, Minneapolis, MN, US; 4Indiana Center for Neurosurgery, Indianapolis, IN, US
BACKGROUND CONTEXT: Lumbar spinal stenosis (LSS) is a source of significant morbidity and economic burden with an estimated prevalence of 8%-27%, resulting in over 37,000 Medicare surgeries per year. Laminectomy is often performed to treat LSS but interspinous device insertion is a less invasive option with potentially decreased operative times and patient risk but with the potential for device removal and laminectomy in the future. Studies comparing long-term outcomes have been scarce. PURPOSE: The purpose of this study is to compare long-term outcomes of patients who underwent laminectomy and intraspinous devices with regard to pain, functional status, medication usage and need for further surgery. STUDY DESIGN/SETTING: A single center follow-up survey study was conducted at a tertiary-care teaching hospital. PATIENT SAMPLE: A single surgeon’s database identified all LSS patients who underwent surgical treatment between 2002 and 2010. Adult patients with ICD 9 codes for lumbar spinal stenosis were included in the analysis. Patients’ under the age of 18, revision surgeries, and those with a less than two-year follow-up period were excluded. OUTCOME MEASURES: Oswestry Disability Index (ODI), VAS for back and leg pain, and medication usage profiles. METHODS: Questionnaires consisting of demographic information, Oswestry Disability Index (ODI), VAS for back and leg pain, and medication usage profiles were mailed to patients meeting inclusion criteria. A second mailing and telephone administration targeted nonrespondents. RESULTS: Of the 223 patients who met the inclusion criteria, 113 responded to the survey. 63 were laminectomies and 50 were intraspinous devices. Length of follow-up was 5.5 and 4.8 (p50.019) for the laminectomy and intraspinous device groups. Age was significantly different in the laminectomy and intraspinous device groups (57 and 72.7; p!0.001). Preoperative leg pain was significantly worse in the laminectomy group but there were no other significant differences in
BACKGROUND CONTEXT: The sacroiliac joint has been implicated as one of the causes of chronic low back pain. The mainstay of sacroiliac joint (SIJ) disruption/sacroiliitis therapy has been nonoperative management. When this fails, SIJ fusion has been the standard treatment. Open and minimally invasive (MIS) techniques are typical procedures. It is important to compare the safety and effectiveness of surgical interventions to help both surgeons and patients make more informed decisions about treatment for SI joint disorders. PURPOSE: This study aims to compare the Oswestry Disability Index (ODI) outcomes and perioperative process measures associated with both open and MIS techniques. STUDY DESIGN/SETTING: Comparative retrospective chart review of SIJ fusion patients with minimum 1-year follow-up. PATIENT SAMPLE: From 2006-2012, 49 patients from two institutions underwent SIJ fusions. Ten were excluded for incomplete data resulting in 39 patients. OUTCOME MEASURES: Oswestry Disability Index (ODI) outcomes and perioperative process measures. METHODS: Comparative retrospective chart review of SIJ fusion patients with minimum 1-year follow-up. Surgical time, hospital stay, estimated blood loss and ODI scores were compared using Student’s t-test. RESULTS: 22 patients underwent open and 17 underwent MIS SIJ fusion. All patients had sacroiliitis confirmed by SIJ anesthetic injection and physical exam. Females outnumbered males in both groups. MIS group subjects were significantly older than the open group subjects (64 vs 51 years). The open group had significantly fewer patients with a history of spine surgery (50% vs 82%). Preoperative ODI did not differ significantly between the two groups. Postoperative improvement in ODI was statistically significant within and between groups (p!0.001) with MIS resulting in nearly 3 times greater improvement (38 vs 14 pt improvement, respectively). Surgical time (28 vs 128 mins) and hospital stay (1 vs 3 days) were significantly shorter in MIS than the open group. Limitations include: small sample size, retrospective nature of study, short follow-up period and variability
Refer to onsite Annual Meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosures and FDA device/drug status at time of abstract submission.