34. Unipedicular Balloon Kyphoplasty for the Treatment of Osteoporotic Vertebral Compression Fractures

Proceedings of the NASS 22nd Annual Meeting / The Spine Journal 7 (2007) 1S–163S analyses of surgical outcomes of T-OPLL have been difficult because this disease is rare and the number of patients at a single institute is limited. PURPOSE: The purpose of the study was to evaluate the results of surgery and complications and to find an optimal surgical option for T-OPLL. STUDY DESIGN/SETTING: A multi-institutional retrospective study. PATIENT SAMPLE: The subjects were 154 patients with T-OPLL who were surgically treated at 34 institutions during the 5-year period between 1998 and 2002 and who were followed for at least 1 year (62 males and 92 females; mean age, 56.8 years; mean follow-up period, 3.0 years). The level of the maximum ossification was T1-T4 in 68 patients, T5-T8 in 61, and T9-T12 in 22. OUTCOME MEASURES: Assessments were made on 1) The Japanese Orthopaedic Association (JOA) score (full marks, 11 points), its recovery rate, and Modified Frankel classification, 2) factors related to surgical results, and 3) complications and their sequelae. METHODS: The surgical procedures were laminectomy in 37, laminoplasty in 36, anterior decompression and fusion by the anterior approach in 25, anterior decompression by the posterior approach in 29, and others in 13 patients. Instrumentation was conducted in 52 patients (33%). The ossified lesion was excised in 48, thinned and floated in 25, and left unresected in 81 patients.

Figure 1. RESULTS: 1) The mean JOA score before surgery was 4.662.0 and, 7.162.5 after surgery. The mean recovery rate was 36.8647.4%. In modified Frankel classification, there was improvement by at least one grade in 107 patients (69.5%), no change in 38 (24.7%) and aggravation in 9 (5.8%). 2) The recovery rate was 25% or higher in 104 patients (67.5%). Factors significantly related to the recovery rate of 25% or higher were location of the maximum ossification at the upper thoracic vertebrae (T1-T4) (age- and sex-matched odds ratio: 2.43–4.17) and use of instrumentation (the odds ratio: 3.37). Morbid period, preoperative JOA score, and surgical procedures were not significantly related to the recovery rate. 3) The complications recognized were deterioration of myelopathy immediately after surgery in 18 (11.7%), epidural hematoma in 3 (1.9%), and dural injury in 34 (22.1%) patients. In 12 (66.7%) of 18 patients with aggravation, the paralysis improved spontaneously 5.6 days on average after surgery. CONCLUSIONS: The mean recovery rate of JOA score was worse than that of cervical OPLL reported in the literatures. The factors significantly associated with favorable surgical results were maximum ossification located at the upper thoracic spine and use of instrumentation. The upper

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thoracic spine is close to the lower cervical spine, where lordosis exists and T-OPLL at the upper thoracic spine could be treated by laminectomy or laminoplasty that is relatively safe for neural elements. The use of instrumentation allows correction of kyphosis and stabilization of the spine, thereby, enhancing and maintaining decompression effect, and its use should be taken into consideration particularly when posterior decompression is conducted. The aggravation of paralysis immediately after surgery was observed in more than 10 % of the patients, but spontaneous improvement in paralysis could be expected in more than half of the patients. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2007.07.040

34. Unipedicular Balloon Kyphoplasty for the Treatment of Osteoporotic Vertebral Compression Fractures Elias Papadopoulos, MD1, Folorunsho Edobor-Osula, MPH1, Michael Gardner, MD2, Michael Shindle, MD2, Joseph Lane, MD2; 1New York, NY, USA; 2Hospital for Special Surgery, New York, NY, USA BACKGROUND CONTEXT: Studies have demonstrated that bipedicular kyphoplasty is a safe and effective procedure for the treatment of pain associated with osteoporotic vertebral compression fractures. Biomechanical testing showed that experimental unilateral kyphoplasty had comparable properties to bipedicular kyphoplasty. Thus this technique would be an attractive alternative to the traditional bipedicular kyphoplasty, due to theoretical speed, safety and less expense. However, to date no clinical data are available regarding the efficacy and safety of unilateral balloon kyphoplasty. PURPOSE: To evaluate the clinical and radiographic outcomes of the unipedicular-unilateral balloon kyphoplasty in osteoporotic vertebral compression fractures (VCFs). STUDY DESIGN/SETTING: Prospective observational study. PATIENT SAMPLE: 317 kyphoplasty procedures performed in 142 patients with osteoporotic VCFs, using the unilateral technique. OUTCOME MEASURES: To evaluate improvement in pain and physical function, preoperative and postoperative scores of visual analog scale (VAS), SF-36 and Oswestry disability index (ODI) were compared, at 3 and 12 months postoperatively. Complications were recorded. Height restoration and overall coronal and sagital spinal alignment was assessed pre and post-operatively. METHODS: 317 kyphoplasty procedures were performed in 142 patients with osteoporotic VCFs, using the unilateral technique. This was performed exclusively via extrapedicular cannulation of the vertebral body aiming to the center of the vertebral body. To evaluate improvement in pain and physical function, preoperative and postoperative scores of visual analog scale (VAS), SF-36 and Oswestry disability index (ODI) were compared, at 3 and 12 months postoperatively. Complications related to the procedure and cement extravasation rates were recorded. Height restoration and overall coronal and sagital spinal alignment was assessed pre and post-operatively. RESULTS: Mean midvertebral height restoration was found 48.9%; when vertebral levels treated were stratified into two groups, with or without height restoration (90.1% and 9.9% of all levels respectively), corrected mean midvertebral height restoration was found 54%. No lateral wedging or changes in the coronal alignment were observed. Significant improvement on the VAS, SF-36 scores and ODI was noted postoperatively; nevertheless at the 12-month follow-up only 30 patients completed the SF-36 questionnaire, whereas the VAS/ ODI was completed by only 19 patients. No complication was recorded; 34 cases (10.73%) of cement extravagation were all asymptomatic. CONCLUSIONS: Unipedicular-unilateral extrapedicular kyphoplasty is both a safe and efficacious alternative to the traditional bipedicular kyphoplasty for the treatment of painful osteoporotic VCFs. As technique, it is faster, less expensive and involves less radiation exposure for the surgical suite personnel.

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Proceedings of the NASS 22nd Annual Meeting / The Spine Journal 7 (2007) 1S–163S

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2007.07.041

35. En Bloc Spondylectomy in the Treatment of Spine Tuberculosis with Fixed, Sharply Angulated Kyphotic Deformity Youwen Deng, MD1, Guohua Lv, MD1, Howard An, MD2; 1Changsha, Hunan, China; 2Chicago, IL, USA BACKGROUND CONTEXT: Spine tuberculosis may be associated with fixed angulated kyphotic deformity, particularly if neglected or treated late. The conventional treatment of angular kyphosis is a combined anterior and posterior decompression, fusion and stabilization. En bloc spondylectomy via posterior approach alone for the treatment of advanced spinal tuberculosis with fixed, sharply angulated kyphotic deformity is not well established in the literature. PURPOSE: To evaluate clinical outcomes of posterior en bloc spondylectomy in patients with spinal tuberculosis with fixed, sharply angulated kyphotic deformity. STUDY DESIGN/SETTING: A retrospective analysis of 35 consecutive patients with advanced spinal tuberculosis with fixed angulated kyphotic deformity is performed. PATIENT SAMPLE: There were 35 patients with 21 males and 14 females, age ranging from 16 to 55 years with a mean of 24.9 years. All patients had firm diagnosis of spinal tuberculosis and failed medical treatment or delayed treatment, resulting in progressive angular kyphosis. The level of tuberculosis and kyphosis was T9 in 2 patients, T10 in 5, T11 in 13, T12 in 14, and L1 in 11. OUTCOME MEASURES: The outcome measures included: (1) Clinical results as excellent, good, fair or poor, (2) Neurological improvement by ASIA Frankel grade system, (3) Correction of kyphotic deformity, (4) Fusion rate, and (5) Perioperative and follow-up complications. METHODS: From 1998 to 2005, the patients underwent posterior one-stage en bloc spondylectomy by shortening the posterior column thereby reducing tension on the spinal cord. The anterior column with diseased tuberculosis was thoroughly removed by en bloc spondylectomy and titanium mesh, cage, or strut autograft was used to restore the anterior column stability. Posterior pedicle screw fixation and fusion was typically performed. The patients were mobilized with thoracolumbar orthosis, which was worn for 6 months. Follow-up clinical examination and radiographs were obtained at 6 months intevals. RESULTS: All patients survived the operation without perioperative mortality. The average duration of surgery was 208 min (ranging 145–385min) and hospitalization was 12.7 days (ranging 10–29) days. At follow-up, 9(25.7%) patients rated their results as excellent, 24(68.6%) good, and 1(2.8%) fair and 1 (2.8%) poor. Kyphotic cobb angle improved from preoperative average of 56.7 (range 21 to 85 ) to 11.2 . There were 19 patients with preoperative neurological deficits (Frankle C is in 8, Frankel D in 11 cases). Seventeen patients or 90% showed a postoperative improvement in Frankel grade after operation. The immediate postoperative complication rate was 6.9% including pneumonias and superficial infection, screw loosening. Twenty-five (71.4%) showed radiographic evidence of solid fusion at follow-up examinations while remainders had questionable fusion or pseudarthrosis although re-operation was not necessary. CONCLUSIONS: En bloc spondylectomy for the treatment of spinal tuberculosis with fixed, sharply angulated kyphotic deformity can be safe and effective technique. Advantages include one stage operation rather than a combined anterior and posterior procedure, thorough debridement or removal of infected bone, less tension on the spinal cord, and stabilization. However, this procedure is highly technical, and the surgeon must be thoroughly familiar with the pathoanatomy and operation must be executed in a meticulous manner. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2007.07.042

36. An International Multicenter Randomized Comparison of Balloon Kyphoplasty and Non-surgical Management in Patients with Acute Vertebral Body Compression Fractures Douglas Wardlaw, MB,CHB, CHM, FRCSED1, Steven Boonen2, Leonard Bastian, MD3, Jan Van Meirhaeghe, MD4, Steve Cummings5; 1 NHS Grmpian, Woodend Hospital, Aberdeen, Scotland, United Kingdom; 2 UZ Gasthuisberg, Leuven, Belgium; 3Medizinische Hochschule Hannover, Hannover, Germany; 4AZ St Jan, Brugge, Belgium; 5University of California San Francisco, San Fransisco, CA, USA BACKGROUND CONTEXT: Vertebral body compression fractures (VCFs) impair quality of life (QOL) and increase patient morbidity and mortality. Balloon kyphoplasty (BKP) is a minimally invasive surgical option for the treatment of osteoporotic and cancer-related VCFs. PURPOSE: The international, multicenter, randomized, controlled Fracture Reduction Evaluation (FREE) trial was initiated to compare effectiveness and safety of BKP to non-surgical management (NSM) for the treatment of acute painful VCFs. We describe the primary endpoint of the ongoing 2-year study. ¨3 STUDY DESIGN/SETTING: Patients with 1-3 non-traumatic VCFs (¡U months old) were randomly assigned to either BKP or NSM. PATIENT SAMPLE: Patients with VCFs due to primary osteoporosis, corticosteroid-induced osteoporosis, and cancer-related fractures. OUTCOME MEASURES: The primary endpoint, the change in QOL as measured by the SF-36 Health Survey Physical Component Summary (PCS) at one month, and device/procedure-related safety were analyzed in the intent-to-treat population. Secondary endpoints (at one month) were analyzed in a per protocol population and included SF-36 subscales, the global health measure EQ-5D, self-reported back pain and back function using the Roland Morris Disability Questionnaire (RMDQ). All patients were referred for appropriate osteoporosis medical therapy. METHODS: The study was conducted in 28 sites in 8 European countries and 300 patients recruited, and randomised. RESULTS: Among the BKP (N5149) and NSM (N5151) cohorts, mean patient age was 73 years and 77% were female.Most patients had VCFs due to primary osteoporosis; 8 patients due to corticosteroid-induced osteoporosis, and 4 had cancer-related fractures. Thirty-nine BKP (26%) and 36 NSM (24%) patients had O1 VCF treated. For PCS, the mean (SE) ` 1.46 for BKP and 25.7¡A ` 1.47 for NSM; at baseline scores were 26.1¡A ` 1.46 for BKP and one month follow-up, the means scores were 33.6¡A ` 1.49 for NSM. The difference in change was 5.73 points (95% con27.4¡A fidence interval, 3.72-7.75) in favor of BKP over NSM (p!0.0001). All physical component SF-36 subscales and the total EQ-5D score were significantly improved for BKP compared to NSM. Mean (SD) improvements ` 2.6 (7 days) and 3.3¡A ` 2.6 (1 month) for BKP, and in back pain were 3.2¡A ` 1.7 (7 days) and 1.4¡A ` 2.2 (1 month) for NSM (p!0.0001 for differ1.0¡A ence at both time points). Mean (SD) improvement in RMDQ was ` 6.2 for BKP and 2.0¡A ` 4.1 for NSM (p!0.0001 for difference). There 5.9¡A was one device-related serious adverse event (a soft tissue hematoma) and one procedure-related serious adverse event (a postoperative urinary tract infection). There were no bone cement-related serious adverse events. CONCLUSIONS: Compared to non-surgical management, balloon kyphoplasty demonstrated superior short-term pain, function and quality of life outcomes with no difference in serious adverse events for the treatment of acute, painful vertebral compression fractures. Follow-up to two years will document whether these superior outcomes are sustained and whether BKP affects the natural history of osteoporotic vertebral compression fractures. (Clinicaltrials.gov number, NCT00211211). FDA DEVICE/DRUG STATUS: Balloon Kyphoplasty: Approved for this indication. doi: 10.1016/j.spinee.2007.07.043

37. Comparison of Long Fusion to L5 and the Sacrum for Degenerative Lumbar Scoliosis Kyu Jung Cho, MD1, Se-Il Suk, MD2, Seung-Rim Park3, Young-Hyun Yun, MD3; 1Inha University Hospital, Incheon, Incheon,