Proceedings of the NASS 21st Annual Meeting / The Spine Journal 6 (2006) 1S–161S posterior spinal fusion with titanium pedicle screw instrumentation. Intraand postoperatively, all were evaluated for clinical evidence of screw malposition, with particular attention placed on identifying any new radiculopathy. Before discharge from the hospital, all patients underwent CT scanning of the lumbar spine to evaluate the position of each pedicle screw. The results of these investigations were then collected retrospectively. RESULTS: 19 consecutive patients were evaluated: 11 women, and 8 men. Mean age was 57 years (range 42–76). Mean preoperative Cobb angle measured 34 degrees (range 15–64 degrees). A total of 151 pedicle screws were inserted. One patient had developed new radiculopathy after surgery; CT scan confirmed a screw with medial pedicle perforation of approximately 5 mm. This patient underwent screw removal within the same hospital admission, with immediate and complete resolution of her radiculopathy. There were no other cases with clinical evidence of screw malposition, and no cases with postoperative neurologic deficit, dural tear, or vascular injury. Postoperative CT scans showed an additional 11 screws with suboptimal position: 3 screws violated the medial pedicle wall, both by !2 mm; 3 screws violated the lateral pedicle wall (2 by!2mm, one by between 2–4mm); 2 screws violated the inferior pedicle wall, both by !2mm; 3 screws penetrated the anterior cortex of the vertebral body, both by !2mm, with no proximity to vascular structures or other viscera. CONCLUSIONS: Pedicle screw fixation in lumbar degenerative scoliosis can be challenging, with 1 of 19 patients (5.3%) developing radicular symptoms as a result of screw malposition. However, prompt attention to this development can satisfactorily resolve these issues, and there were no cases of neurologic deficits or other injuries. Overall, 12 of 151 screws (7.9%) were in a suboptimal position, with only one screw (representing 0.7% of all screws placed) causing any symptoms. FDA DEVICE/DRUG STATUS: Pedicle screw: Not approved for this indication. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2006.06.368
P158. Comparison of Radiographic Parameters Pre and Postoperative Between Cervical Total Disc Arthroplasty (TDA) with Anterior Cervical Discectomy and Fusion (ACDF) Anthony Petrizzo, DO, John A. Bendo, MD, Jeffrey M. Spivak, MD, Jeffrey A. Goldstein, MD; Hospital for Joint Diseases, New York, NY, USA BACKGROUND CONTEXT: Long-term benefits of TDA focus on restoring motion to prevent adjacent level degeneration. PURPOSE: The purpose of the current study is to compare Prodisc C TDA to ACDF with respect to sagittal alignment, lateral bending, and total range of motion. STUDY DESIGN/SETTING: A clinical, multi center, prospective trail is underway. Surgeons at a single center preformed a total of 23 surgeries. The groups were randomized between TDA and ACDF procedures (11 and 12, respectively). PATIENT SAMPLE: Surgeons at a single center preformed a total of 23 surgeries. The groups were randomized between TDA and ACDF procedures (11 and 12, respectively). OUTCOME MEASURES: Outcomes measured include prepoerative and postoperative local and global sagittal alignment, range of motion at the operative leval and globally. METHODS: Range of motion was assessed by measuring Cobb angles on AP, lateral, flexion and extension radiographs. Cobb angles were measured at the operative level and from C2 to C7 on all lateral radiographs. Preoperative radiographs were compared with the most current postoperative follow-up radiographs. RESULTS: Preoperativly, TDA patients had an average sagittal alignment of.1 lordosis from C2-C7 and .3 of lordosis at the operative level. This was improved postoperatively to 7.2 and 5.3 at the operative level. ACDF patients had 4.6 and 1.0 of cervical lordosis preoperative which improved to 6.2 from C2-C7 and 5.2 at the operative level. Patients whom
159S
underwent TDA had 20.8 of motion with flexion-extension from C2 to C7 and 9.8 at the operative level preoperatively which changed to 42.3 C2C7 and 9.0 at the operative level Average preoperative motion was 42 of motion from C2-C7 on our ACDF patients and 9.1 of motion at the operative level which was decreased to 42 from C2-C7 and only 1 at the operative level. Patients who had undergone ACDF had a significant decrease in postoperative flexion (p!.05). Preoperative side bending was 30.1 from C2-C7, and 3 at the operative level of patients whom underwent ACDF. This was decreased postoperatively to 26.7 and.4 at the operative level. Preoperative TDA patients had 37 from C2-C7, and 3 at the preoperative level, which changed to 25.4 and 4.4 at the operative level. CONCLUSIONS: At current follow-up TDA demonstrates improvement in sagittal alignment as well as range of motion in the sagittal and coronal plane compared with ACDF. FDA DEVICE/DRUG STATUS: Prodisc C: Investigational/not approved. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2006.06.369
P159. Identifying Maximum Medical Improvement for Back Injury Rehabilitation Utilizing Sports Performance Based Work Conditioning/Hardening Following Physical Therapy Jamie Stark, PhD, CSCS, HFI1, Matthew Kruger, MS, CSCS2, Mike Zbreski, MS3, Dylan Bates, MS4, Gregory Steil, EP5; 1ATI Physical Therapy, Chicago, IL, USA; 2Athletic and Therapeutic Institute, Romeoville, IL, USA; 3ATI Physical Therapy, Romeoville, IL, USA; 4 Athletic and Therapeutic Institute, Joliet, IL, USA; 5ATI Physical Therapy, Willowbrook, IL, USA BACKGROUND CONTEXT: The current shift towards evidence based medicine has dictated that physical medicine providers become more objectively accountable for their protocols. The establishment of national benchmarks is largely the result of analyzing ‘usual and customary’ trends in the industry and therefore may not provide an accurate index of maximum medical improvement. PURPOSE: The purpose of this study was to model the resistance training progression program for back injury rehabilitation in a sports performance based work conditioning/hardening (SPWC/H) following standard physical therapy. STUDY DESIGN/SETTING: A six-month multi-center (outpatient rehabilitation) study utilized concurrent monitoring of patient programs to assess weekly functional capabilities of subjects during SPWC/H. PATIENT SAMPLE: Between July and December 2005, a total of 46 male subjects being rehabilitated for a back injury were monitored. Subjects were discharged from traditional physical therapy programs before entering the program. Diagnoses as listed in patient charts were lumbar rupture (4), lumbar herniation (23), degenerative disc disease (5), spondylolysis (1), low back pain (2), lumbar strain (9), discogenic pain (1), and hardware removal post fusion (1). Twenty-four subjects were post surgery (14 fusion, 10 discectomy). Subjects completed a minimum of 4 weeks in SPWC/H, attended at least 75% of scheduled sessions, and were allowed full program progression. OUTCOME MEASURES: Physical demand level (PDL). METHODS: Physical demand level (PDL) was measured weekly for up to 12 weeks by assessing performance in a floor-to-waist lift. In 36 patients a functional capacity assessment (FCA; Key Method) was performed at program completion to determine the absolute PDL. PDL was classified by occasional occupational lifting requirements: LIGHT (20lbs), LIGHTMEDIUM (35lbs), MEDIUM (50 lbs), MEDIUM-HEAVY (75lbs), HEAVY (100lbs), VERY HEAVY (O100lbs). For analysis, PDL was assigned a numerical value: LIGHT51, LIGHT-MEDIUM52, MEDIUM53, MEDIUM-HEAVY54, HEAVY55, VERY-HEAVY56. Student’s t tests and a one-way ANOVA were used to measure differences between groups. Significance was set at p!.05. Fisher’s Exact test was utilized for post hoc analysis. Data are mean6SEM.
160S
Proceedings of the NASS 21st Annual Meeting / The Spine Journal 6 (2006) 1S–161S
RESULTS: Mean sessions before discharge were 3562 (mean attendance 921%.). PDL increased significantly from 1.6560.12 at program start to 3.5160.16 at completion (p!.05). PDL as determined by FCA was significantly greater than approximated by floor-to-waist lifting (4.1661.15 vs. 3.5160.16 respectively; p!.05). PDL as approximated by floor-to-waist lift changed significantly between weeks 1–2, 2–3, 3–4, 4–5, 5–7, 6–8, 7–10 (p!.05 for each pair). There were no significant differences between Week 8 and any later time point thru Week 12. CONCLUSIONS: These results demonstrate that functional improvements occur rapid (weekly) in the early phase of SPWC/H as evidenced by the significant weekly differences thru Week 5. Additional functional improvements occurred at a decreased rate (every two weeks) thru Week 8. A small but significant increase occurred between Week 7 and 10. Correcting for the difference between floor-to-waist approximated and FCA measured PDL, the difference in PDL between weeks 4 (MEDIUM), 8 (MEDIUM-HEAVY), and 10 (MEDIUM-HEAVY) suggests that maximum medical improvement was typically reached during the 8th week of rehabilitation. These results provide an evidence based mechanism to identify maximum medical improvement in patients enrolled in SPWC/H. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2006.06.370
P160. Tuberculosis Spine: Management Strategies in a Developing Country Dwarakanath Srinivas1, Venkataramana Neelamkrishna1, Swaroop Gopal2, Satish Rangappa3; 1Manipal Hospital, Bangalore, India; 2 Manipal Institute for Neurological Disorders, Manipal Hospital, Bangalore, Bangalore, India; 3Manipal Institute for Neurological Disorders, Bangalore, India BACKGROUND CONTEXT: Tuberculosis is one of the most common infectious diseases in India especially in the lower socioeconomic strata. Spinal tuberculosis is a major cause of morbidity and can have devastating neurological sequelae if improperly managed. PURPOSE: In this retrospective study we review the various presentations and surgical management strategies in spinal tuberculosis. We also review the data on the patients with multi-drug-resistant (MDR) tuberculosis. STUDY DESIGN/SETTING: This retrospective study included all patients who were operated for spinal tuberculosis at our institute between 1994 and 2005. The data on all these patients were analyzed from the inpatient files. PATIENT SAMPLE: Ninety-eight cases of spinal tuberculosis were operated between 1994 and 2004 at our institute. The important surgical issues were relief of compressive myelopathy, reduction or prevention of instability, and histopathological diagnosis of the lesions. OUTCOME MEASURES: The outcome measure was the clinical response to therapy. METHODS: The follow-up was collected from the outpatient files. The antitubercular drugs used, and duration of therapy with special reference to multidrug resistance was analyzed. A complete neurological evaluation was performed at every OPD visist to assess the response. A follow-up radiological evaluation with X-rays and MRI (where indicated) was performed at the end of drug therapy or if patient deteriorated on treatment. RESULTS: The commonest age group of presentation was between the second and third decade. Pain (92%), progressive myelopathy (80%), bladder disturbance (28%), and skeletal deformities (16%) were the common modes of presentation. Radiological evaluation revealed that the thoracic spine was the most common site of infection. 22% of the patients had instability and required instrumentation. Cold abscess was seen in 28% of patients. The surgical approach (anterior, lateral, or posterior) was based on the location of the lesion. The neurological outcome depended on the preexisting motor deficits and the location of the lesion. Lumbar
tuberculosis had good outcome, whereas dorsal tuberculosis had a relatively higher morbidity followed by cervical tuberculosis. 19% of these patients had drug resistance and needed second-line drug therapy. Two patients who underwent instrumentation needed implant revision due to progression of disease. Both the patients had MDR TB. CONCLUSIONS: Aggressive surgical management along with antitubercular drug therapy is necessary for optimal management and preventing further deterioration. Instrumentation when indicated allows early ambulation and prevents spinal deformities. MDR tuberculosis needs to be recognized early and managed with second-line ATT for good results. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2006.06.371
P161. A Novel, Minimally Invasive Access Technique for StandAlone Lumbar Interbody Fusion in Spondylolisthesis: Preliminary 13-Month Results on the Deployable Optimesh Graft Device Sandi Lam, MD1, Giancarlo Guizzardi, MD2, Ricardo Morichi, MD2, Alessandro Vagaggini, MD2, Larry Khoo, MD3; 1University of California, Los Angeles, Los Angeles, CA, USA; 2Careggi Hospital, Florence, Tuscany, Italy; 3Los Angeles, CA, USA BACKGROUND CONTEXT: Optimesh (Spineology, Stillwater, Minnesota) is a novel deployable interbody device used here for lumbar interbody fusion in spondylolisthesis by a minimally invasive access technique. It is inserted through a fixed 8-mm cannula, expands in situ when filled with allograft, and minimizes the degree of extensive facet removal and neural retraction typically required for exchange of working tools and insertion of fixed cages in posterior interbody procedures. PURPOSE: This study characterizes the preliminary experience with Optimesh for in situ interbody fusion for lumbar spondylolisthesis. STUDY DESIGN/SETTING: This is a retrospective case series of 18 patients with adult spondylolisthesis who underwent lumbar fusion with the Optimesh system. PATIENT SAMPLE: n518. OUTCOME MEASURES: Data were collected through personal interview, clinical examination, radiographic analysis, and medical record review. Radiographic parameters, Visual Analog Scale for pain pre- and postoperatively, time for return to activity, length of hospital stay, length of surgical time, and estimated blood loss were recorded. METHODS: 18 patients from 33 to 76 years of age (average 58 years), 10 female and 8 male, with spondylolisthesis at L3-4, L4-5, or L5-S1 were treated with minimally invasive decompression and interbody fusion with Optimesh. Postoperative follow-up ranged from 8 to 24 months (average 13 months). RESULTS: Operative times ranged from 110 to 240 minutes (mean 177 minutes). Blood loss was uniformly less than 100 cc. There were no durotomies, neural injuries, transient or permanent paresthesias, or blood transfusions. Two superficial wound infections resolved with antibiotic therapy, and irrigation and debridement without removal of instrumentation. Clinical follow-up revealed a preoperative Visual Analog Scale mean of 8.7, VAS mean of 2.7 one week after surgery, and return to activity in a mean of 49 days (range 10 to 240 days). Radiographic follow-up with Xray, CT, and MRI showed the Optimesh engaged between vertebral body end plates in a lock-and-key type configuration, no increase in spondylolisthesis, and no instability on lumbar flexion/extension X-rays at 3 to 12 months. CONCLUSIONS: Preliminary 13-month results of the Optimesh system used in lumbar interbody fusion for spondylolisthesis demonstrate it to be a viable interbody fusion device with minimal risk for intraoperative complications characteristically associated with fixed-sized grafts and cages.