66. Symptomatic retained lumbar hardware

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Proceedings of the NASS 19 th Annual Meeting / The Spine Journal 4 (2004) 3S–119S 35S or lifting heavy objects, which was within normal activity of daily living (odds ratio [OR]: 26.7, p0.010); those in more aged population (OR/10 years: 12.0, p0.012); and those with middle column involvement (OR: 9.7, p0.038). The other factors such as severity of initial injuries were proved to be insignificant. Predicted probability [p] of vertebral pseud- arthrosis was calculated by following equation: pexp λ/(1exp λ) [λ2.801×10.129×21.771×3- 13.145: ×1injury events, ×2ages at initial injury, ×3middle column involvement]. An example of vertebral fractures with extremely high-risk ([p] is around 90%) for pseudarthrosis was those with middle column involvement in 80 year-old patients who sustained injuries by twisting their trunks. CONCLUSIONS: Osteoporotic vertebral pseudarthrosis is becoming a serious problem of today’s aging society because that causes painful kypho- sis with or without neurological involvement. Although this condition fre- quently needs spinal reconstruction, many patients are intolerable for such major surgery because of poor medical status and severe osteoporosis. Therefore, prevention is essential for successful management of osteopo- rotic vertebral fractures. Estimate of high-risk fracture allows early selection of the candidate for adequate and less invasive initial treatment such as kyphoplasty for osteoporotic vertebral fractures. DISCLOSURES: No disclosures. CONFLICT OF INTEREST: No Conflicts. doi: 10.1016/j.spinee.2004.05.066 4:36 66. Symptomatic retained lumbar hardware Benjamin Cunningham, Robert Henderson; Dallas Spine Care, Dallas, TX, USA BACKGROUND CONTEXT: Spinal internal fixation is a common ad- junct to facilitate lumbar fusion. Low back pain can persist even in a radiographically solid fusion. Symptomatic retained hardware is a possi- ble etiology. PURPOSE: The study was intended to investigate if segmental instrumen- tation placed during lumbar fusion surgery can produce late symptoms presenting as low back pain; and if subsequent removal of the instrumenta- tion diminishes recurrent low back pain. STUDY DESIGN/SETTING: A retrospective review of patients who underwent circumferential lumbar fusion surgery. PATIENT SAMPLE: 25 patients who developed recurrent low back pain after a successful asymptomatic circumferential spine fusion with adjunct segmental posterior spinal instrumentation. OUTCOME MEASURES: Visual Analog Pain Scale, NASS satisfac- tion survey. METHODS: A retrospective analysis of 25 patients with a solid radio- graphic circumferential fusion who initially had an excellent clinical re- sponse to surgery presented with return of low back pain. Tenderness was localized over the retained hardware. In some cases haloing was seen around the screw-bone interface. After other etiologies were excluded painful retained hardware was entertained. Removal of the hardware and assessment of the fusion was performed. Patients were followed up clinically and radiographically. RESULTS: Average date from initial surgery to return of symptoms was 11 months. All patients had radiographic solid fusion. The hardware was removed and operative assessment of fusion was performed. Intertrans- verse pseudarthrosis was found in one patient who was treated with bone grafting. A non-infectious fluid collection was noted in 10 patients. Aver- age reduction in pain was 71.6%. Twenty three patients described the surgery as helpful in reduction of symptoms and 96% in retrospect would have the surgery performed again. Patient follow up averaged 4.7 years. CONCLUSIONS: Symptomatic retained hardware after a successful fusion procedure has not been described in the literature. After removal of the instrumentation the majority improved in function and diminished pain. Patients presenting recurrence of low back symptoms or failed back surgery, if appropriate, should undergo removal of symptomatic instrumentation. Research in the reactive properties and etiologies of this phenomenon need future research. DISCLOSURES: No disclosures. CONFLICT OF INTEREST: No Conflicts. doi: 10.1016/j.spinee.2004.05.067 Thursday, October 28, 2004 4:20–4:50 PM Concurrent Focused Reviews 2B: Lumbar Fusion Outcomes 4:20 67. A large randomized clinical evaluation of rhBMP-2 versus iliac crest bone graft combined with cortical allograft in lumbar spine fusion J. Kenneth Burkus 1 , Matthew Gornet 2 , Michael Longley 3 ; 1 Hughston Clinic, Columbus, GA, USA; 2 Orthopedic Center of St. Louis, St. Louis, MO, USA; 3 Nebraska Spine Center, Omaha, NE, USA BACKGROUND CONTEXT: Recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge (rhBMP-2/ACS) has been shown in a small series of patients1 to promote new bone formation and incorporation of the allograft device in patients undergoing anterior lumbar interbody fusions (ALIF) with threaded cortical allografts, but a larger series with longer follow up is needed. PURPOSE: To compare the efficacy and safety of rhBMP-2/ACS with iliac crest autograft when used with cortical allograft bone dowels in single- level, stand-alone ALIFs. STUDY DESIGN/SETTING: Prospective, randomized, nonblinded study at 13 investigational sites. PATIENT SAMPLE: Patients had symptomatic, one level lumbar degen- erative disc disease with less than Grade I spondylosis and underwent stand-alone ALIF using threaded cortical allografts (MD II Bone Dowels, Regeneration Technologies) at either the L4–5 or L5-S1 disc space. There were no statistical differences between the demographics of the two groups with regard to age, weight, sex, workers’ compensation, spinal litigation, tobacco use, or previous surgeries. OUTCOME MEASURES: Clinical outcomes were assessed using the Osw- estry Disability Index, SF-36, work status, and back and leg pain question- naires. Plain radiographs and thin-slice CT scans were used to evaluate fusion. METHODS: As part of an FDA IDE trial, 85 patients were randomly assigned to 1 of 2 groups: a control group (30 patients) who received autogenous iliac crest bone graft or an investigational group (55 patients) who received rhBMP-2/ACS (INFUSE Bone Graft, Medtronic Sofamor Danek) at a final concentration of 1.5 mg/ml. Clinical and radiographic assessments were done preoperatively, and at 1.5, 3, 6, 12, and 24 months after surgery. Fusion assessment with CT scans was done at 6, 12 and 24 months. RESULTS: Average operative time (1.2 hours; P.001) and blood loss (71.4 mL; P.001) in rhBMP-2 patients were less than in the controls (1.7 hrs and 140.5 mL, respectively). Average hospital stay was also reduced but not statistically significant in the investigational group (2.7 vs 3.1 days). Mean Oswestry scores in the rhBMP-2 patients improved 33.1 points; control patients improved 31.5 points, and there were greater improvements in SF-36 evaluations in the rhBMP-2 group. Average back pain scores im- proved by 8.5 and 8.4 points (20 point scale) at 24 months for rhBMP-2 and control patients, respectively. Average leg pain scores improved by 6.9 and 6.2 points (20 point scale) at 24 months for rhBMP-2 and control patients, respectively. There was no donor site pain in the rhBMP-2 patients, but this pain persisted in the control group at 24 months. Of the rhBMP- 2 patients, 70.8% returned to work by 24 months compared with 65.5% who were working before surgery. Of control patients, 63.6% were working at 24 months compared with 53.3% before surgery. In the rhBMP-2 group,

Transcript of 66. Symptomatic retained lumbar hardware

Proceedings of the NASS 19th Annual Meeting / The Spine Journal 4 (2004) 3S–119S 35S

or lifting heavy objects, which was within normal activity of daily living(odds ratio [OR]: 26.7, p�0.010); those in more aged population (OR/10years: 12.0, p�0.012); and those with middle column involvement (OR:9.7, p�0.038). The other factors such as severity of initial injuries wereproved to be insignificant. Predicted probability [p] of vertebral pseud-arthrosis was calculated by following equation: p�exp λ/(1�exp λ)[λ�2.801×1�0.129×2�1.771×3- 13.145: ×1�injury events, ×2�ages atinitial injury, ×3�middle column involvement]. An example of vertebralfractures with extremely high-risk ([p] is around 90%) for pseudarthrosiswas those with middle column involvement in 80 year-old patients whosustained injuries by twisting their trunks.CONCLUSIONS: Osteoporotic vertebral pseudarthrosis is becoming aserious problem of today’s aging society because that causes painful kypho-sis with or without neurological involvement. Although this condition fre-quently needs spinal reconstruction, many patients are intolerable for suchmajor surgery because of poor medical status and severe osteoporosis.Therefore, prevention is essential for successful management of osteopo-rotic vertebral fractures. Estimate of high-risk fracture allows early selectionof the candidate for adequate and less invasive initial treatment such askyphoplasty for osteoporotic vertebral fractures.DISCLOSURES: No disclosures.CONFLICT OF INTEREST: No Conflicts.

doi: 10.1016/j.spinee.2004.05.066

Thursday, October 28, 20044:20–4:50 PM

Concurrent Focused Reviews 2B: LumbarFusion Outcomes

4:2067. A large randomized clinical evaluation of rhBMP-2 versus iliaccrest bone graft combined with cortical allograft in lumbar spinefusionJ. Kenneth Burkus1, Matthew Gornet2, Michael Longley3; 1HughstonClinic, Columbus, GA, USA; 2Orthopedic Center of St. Louis, St. Louis,MO, USA; 3Nebraska Spine Center, Omaha, NE, USA

BACKGROUND CONTEXT: Recombinant human bone morphogeneticprotein-2 on an absorbable collagen sponge (rhBMP-2/ACS) has beenshown in a small series of patients1 to promote new bone formation andincorporation of the allograft device in patients undergoing anterior lumbarinterbody fusions (ALIF) with threaded cortical allografts, but a larger serieswith longer follow up is needed.PURPOSE: To compare the efficacy and safety of rhBMP-2/ACS withiliac crest autograft when used with cortical allograft bone dowels in single-level, stand-alone ALIFs.STUDY DESIGN/SETTING: Prospective, randomized, nonblinded studyat 13 investigational sites.PATIENT SAMPLE: Patients had symptomatic, one level lumbar degen-erative disc disease with less than Grade I spondylosis and underwentstand-alone ALIF using threaded cortical allografts (MD II Bone Dowels,Regeneration Technologies) at either the L4–5 or L5-S1 disc space. Therewere no statistical differences between the demographics of the two groupswith regard to age, weight, sex, workers’ compensation, spinal litigation,tobacco use, or previous surgeries.OUTCOME MEASURES: Clinical outcomes were assessed using the Osw-estry Disability Index, SF-36, work status, and back and leg pain question-naires. Plain radiographs and thin-slice CT scans were used to evaluate fusion.METHODS: As part of an FDA IDE trial, 85 patients were randomlyassigned to 1 of 2 groups: a control group (30 patients) who receivedautogenous iliac crest bone graft or an investigational group (55 patients)who received rhBMP-2/ACS (INFUSE Bone Graft, Medtronic SofamorDanek) at a final concentration of 1.5 mg/ml. Clinical and radiographicassessments weredonepreoperatively, andat1.5, 3,6,12, and24 monthsaftersurgery. Fusion assessment with CT scans was done at 6, 12 and 24 months.RESULTS: Average operative time (1.2 hours; P�.001) and blood loss(71.4 mL; P�.001) in rhBMP-2 patients were less than in the controls (1.7hrs and 140.5 mL, respectively). Average hospital stay was also reducedbut not statistically significant in the investigational group (2.7 vs 3.1 days).Mean Oswestry scores in the rhBMP-2 patients improved 33.1 points; controlpatients improved 31.5 points, and there were greater improvements inSF-36 evaluations in the rhBMP-2 group. Average back pain scores im-proved by 8.5 and 8.4 points (20 point scale) at 24 months for rhBMP-2and control patients, respectively. Average leg pain scores improved by6.9 and 6.2 points (20 point scale) at 24 months for rhBMP-2 and controlpatients, respectively. There was no donor site pain in the rhBMP-2 patients,but this pain persisted in the control group at 24 months. Of the rhBMP-2 patients, 70.8% returned to work by 24 months compared with 65.5%who were working before surgery. Of control patients, 63.6% were workingat 24 months compared with 53.3% before surgery. In the rhBMP-2 group,

4:3666. Symptomatic retained lumbar hardwareBenjamin Cunningham, Robert Henderson; Dallas Spine Care, Dallas,TX, USA

BACKGROUND CONTEXT: Spinal internal fixation is a common ad-junct to facilitate lumbar fusion. Low back pain can persist even in aradiographically solid fusion. Symptomatic retained hardware is a possi-ble etiology.PURPOSE: The study was intended to investigate if segmental instrumen-tation placed during lumbar fusion surgery can produce late symptomspresenting as low back pain; and if subsequent removal of the instrumenta-tion diminishes recurrent low back pain.STUDY DESIGN/SETTING: A retrospective review of patients whounderwent circumferential lumbar fusion surgery.PATIENT SAMPLE: 25 patients who developed recurrent low back painafter a successful asymptomatic circumferential spine fusion with adjunctsegmental posterior spinal instrumentation.OUTCOME MEASURES: Visual Analog Pain Scale, NASS satisfac-tion survey.METHODS: A retrospective analysis of 25 patients with a solid radio-graphic circumferential fusion who initially had an excellent clinical re-sponse to surgery presented with return of low back pain. Tenderness waslocalized over the retained hardware. In some cases haloing was seen aroundthe screw-bone interface. After other etiologies were excluded painfulretained hardware was entertained. Removal of the hardware and assessmentof the fusion was performed. Patients were followed up clinically andradiographically.RESULTS: Average date from initial surgery to return of symptoms was11 months. All patients had radiographic solid fusion. The hardwarewas removed and operative assessment of fusion was performed. Intertrans-verse pseudarthrosis was found in one patient who was treated with bonegrafting. A non-infectious fluid collection was noted in 10 patients. Aver-age reduction in pain was 71.6%. Twenty three patients described thesurgery as helpful in reduction of symptoms and 96% in retrospect wouldhave the surgery performed again. Patient follow up averaged 4.7 years.CONCLUSIONS: Symptomatic retained hardware after a successful fusionprocedure has not been described in the literature. After removal of theinstrumentation the majority improved in function and diminished pain.Patients presenting recurrence of low back symptoms or failed back surgery,if appropriate, should undergo removal of symptomatic instrumentation.

Research in the reactive properties and etiologies of this phenomenon needfuture research.DISCLOSURES: No disclosures.CONFLICT OF INTEREST: No Conflicts.

doi: 10.1016/j.spinee.2004.05.067