Reoperation of decompression alone or decompression plus fusion surgeries for degenerative lumbar diseases: a systematic review.

PURPOSE: The objective of this paper was to compare the reoperation rates, timing and causes between decompression alone and decompression plus fusion surgeries for degenerative lumbar diseases through a systematic review of the published data. METHODS: A search of the literature was conducted on PubMed/MEDLINE, EMBASE and the Cochrane Collaboration Library. Reports that included reoperations after decompression alone and/or decompression plus fusion surgeries were selected using designed eligibility criteria. Comparative analysis of reoperation rates, timing and causes between the two surgeries was conducted. RESULTS: Thirty-two retrospective and three prospective studies were selected from 6401 papers of the literature search. The analysis of data reported in these studies revealed that both surgeries resulted in similar reoperation rates after the primary surgery. However, majority of reoperations following the fusion surgeries were due to adjacent-segment diseases, and following the decompression alone surgeries were due to the same-segment diseases. Reoperation rates were not found to decrease in patients operated more recently than those operated in early times. CONCLUSIONS: Reoperation rates were similar following decompression alone or plus fusion surgeries for degenerative lumbar diseases. However, different underlying major causes exist between the two surgeries. There is no evidence showing that the reoperation rate has a trend to decline with newer surgical techniques used. The exact mechanisms of reoperation after both surgeries are still unclear. Further researches are necessary to investigate the mechanisms of reoperation for improvement of surgical techniques that aim to delay or prevent reoperation after lumbar surgery. These slides can be retrieved under Electronic Supplementary Material.

Persistent radiculopathy after surgical treatment for lumbar disc herniation: causes and treatment options.

PURPOSE: Lumbar disc surgery is a common procedure in the USA. It is frequently performed with good or excellent results in most patients. This article reviews common causes of persistent radiculopathy after surgical intervention. METHODS: We performed an extensive review of the literature as well as applying our own experience. RESULTS: Common causes of persistent leg pain following operative intervention include re-herniation, epidural fibrosis, biochemical/physiologic changes in the nerve root, and psychosocial issues. CONCLUSIONS: Patients with persistent leg pain after surgical treatment of lumbar disc herniation can pose a challenging clinical problem. Summary of these topics and available treatment options are reviewed.

Recent advances in the prevention and management of complications associated with routine lumbar spine surgery.

Lumbar spine surgery is often associated with complications in the perioperative and postoperative periods. Evidence-based literature in the prevention and management of adverse events, including surgical site infection, venous thromboembolism, and positioning-related complications, has advanced the understanding of the etiology of these complications and preventive measures. Cost-effective measures to reduce intraoperative bleeding can lead to a lower incidence of infection, disease transmission, and morbidity in the postoperative period. As the healthcare system receives additional scrutiny with value-based assessments, surgeons, hospitals, and administrators will need to make critical decisions to prevent and manage the complications of lumbar spine surgery.

Current Concepts: Central Cord Syndrome.

Central cord syndrome (CCS) represents a clinical phenomenon characterized by disproportionately greater motor impairment of the upper than of the lower extremities, bladder dysfunction. CSS is the most common form of incomplete traumatic spinal cord injury. The initial description of CSS was reported in 1887 secondary to cervical spinal trauma. However, recent literature describes a heterogenous injury patterns including high-energy and low-energy mechanisms and bimodal patient age distributions. Pathophysiology of clinical symptoms and neurological deficits often is affected by preexisting cervical spondylosis. Urgent clinical diagnosis is dependent on neurological examination and imaging studies. Treatment of CSS is dependent on injury mechanism and compressive lesions, neurological examination, preexisting cervical pathology, and patient-specific comorbidities. This article will review the current concepts in diagnosis, pathophysiology, and treatment of CSS with a highlighted case example.

Efficacy of silicated calcium phosphate graft in posterolateral lumbar fusion in sheep.

BACKGROUND CONTEXT: Conditions requiring posterior lumbar spinal fusion remain a clinical challenge. Achieving arthrodesis using autogenous bone graft is inconsistent when rigid internal fixation such as transpedicular instrumentation is applied. Synthetic materials, particularly calcium phosphate-based ceramics, have shown promise for spine fusion applications, especially when combined with autograft. Silicate substitution has been shown to enhance the bioactivity of calcium phosphates and may obviate the need for autologous supplementation. PURPOSE: Determine efficacy of silicated calcium phosphate (Si-CaP) compared with autograft to generate solid lumbar fusion. STUDY DESIGN: Comparison of healing of instrumented posterolateral lumbar fusion in ewes at 2 and 6 months using Si-CaP or iliac crest autograft. METHODS: Eighteen skeletally mature ewes underwent implantation of either autograft or Si-CaP in the space spanning the L4-L5 transverse process. In vivo quantitative computed tomography (CT) scans were made at 2-month intervals and after euthanasia. Harvested spine segments were radiographed and biomechanically tested in bending at 6 months. Histological assessments were made at 2 and 6 months. RESULTS: Animals receiving Si-CaP graft were biomechanically and radiographically equivalent to those receiving autograft. Fusion mass density and volume were higher for the Si-CaP group throughout the healing period. Si-CaP regenerated normal bone tissue morphology, cellularity, and maturation with no inflammatory responses despite the fact that no autograft, bone marrow aspirate, or blood was mixed with the material. Histomorphometrically, fusion mass was higher for Si-CaP and bony bridging was equivalent when compared with autograft treatment. CONCLUSIONS: Si-CaP was biomechanically, radiographically, and histologically equivalent to autograft in generating a solid, bony, intertransverse process fusion in an ovine model. Both treatment groups achieved 100% bridging fusion after 6 months of healing.

Effect of plate position on clinical outcome after anterior cervical spine surgery.

BACKGROUND CONTEXT: Anterior cervical plates are commonly used to provide immediate stabilization after a variety of cervical spine procedures. It has been assumed that the ideal position for anterior cervical spine plates is centered in the horizontal plane without significant angulation and without overlap of adjacent unfused levels. Nevertheless, postoperative radiographs often demonstrate actual plate position to be lateralized, rotated, or encroaching on the adjacent disc space. There have been no reported systematic studies examining the effect of variations in plate position in a large clinical population. PURPOSE: To evaluate the association between plate position and short-term clinical outcomes after anterior cervical discectomy and instrumented fusion (ACDF). STUDY DESIGN/SETTING: Review of prospectively collected clinical outcomes measures and radiographs. PATIENT SAMPLE: Patients undergoing ACDF surgery by a group of spine surgical specialists at a single institution. OUTCOME MEASURES: Direct and calculated plain radiographic measurements, visual analog scores for neck and arm pain, and SF-36 scores. METHODS: The study population included 200 patients undergoing a one-, two-, or three-level ACDF with instrumentation. Thirteen separate direct measurements and two calculated values of plate position on immediate postoperative radiographs, including lateralization, rotation, and proximity to adjacent disc spaces, were performed in blinded fashion by 3 independent reviewers. Statistical correlation with prospectively collected patient outcomes measures, including VAS for neck and arm pain and SF-36 scores, was performed. RESULTS: In the study population, average plate position was 3.3 mm from the cephalad disc space, 6.4 mm from the caudal disc space, 3.9 degrees angulation in the frontal plate, and 26% laterally displaced from the midline. At average 18.6 months of follow-up, no significant association was identified between any plate position measure and clinical outcomes. CONCLUSIONS: The use of anterior cervical plating by experienced spine surgeons is associated with variation in terms of plate position on postoperative radiographs. Within the range of positions analyzed in this study, no significant association was found between lateralized or rotated plates or plates placed in proximity to adjacent disc spaces and worse short-term clinical outcomes. It should be emphasized that these results and conclusions are based on relatively short-term clinical follow-up and that the long-term effects of variation in implant position remain unknown.

Understanding Financial Statements in Clinical Practice: A Primer.

The purpose of this article is to describe the different types of financial statements and the information they contain regarding the current and long-term financial health of a business practice. These statements are essential to guiding strategic decision making for physicians and executives.

Morphometric Analysis of the Retroperitoneal Vessels With Respect to Lateral Access Surgery in Adult Scoliosis.

STUDY DESIGN: Cross-sectional study reviewing 62 magnetic resonance imaging or computed tomography scans from consecutive adult patients with scoliotic spinal deformity in the thoracolumbar spine. OBJECTIVE: To investigate the variation in anatomic position of retroperitoneal vessels in relationship to curve direction, location, magnitude, and axial rotation of curves in adult scoliosis. SUMMARY OF BACKGROUND DATA: The minimally invasive lateral approach to the thoracolumbar spine avoids manipulation of abdominal and retroperitoneal structures and decreases risk of injury to paraspinal musculature. In adult patients with scoliosis, the varying anatomic relationship between retroperitoneal vessels and intervertebral disk spaces can increase the risk of vascular injury. MATERIALS AND METHODS: Axial images were used to measure the anterior-posterior diameter of the inferior vertebral endplate with respect to the disk space perpendicular to the widest length of the disk. The overlap of the retroperitoneal vessels with the endplate were measured at the cephalad end vertebra, apex, and caudad end vertebra of each curve. Overlap and accessible disk space for individual disk spaces were also measured. RESULTS: There was a significant difference in percentage overlap of the apex and cephalad vertebral endplate and inferior vena cava in right versus left-sided curves (P=0.002). Overlap between the inferior vertebral endplate and inferior vena cava at the cephalad, apex, and caudad end of the curve was significantly different between thoracolumbar and lumbar curves (P<0.05). Axial rotation significantly affected vessel overlap at multiple curve locations. There was a statistically significant difference in accessible disk space when approaching the curve from the concavity versus convexity. CONCLUSIONS: Overlap between retroperitoneal vessels and inferior vertebral endplates at the disk level in scoliotic spines varies significantly with direction of the curvature, level of the deformity, and degree of axial rotation. There is decreased accessible disk space and increased vessel overlap on the concavity of the curve. Surgeons, as usual, will take an individualized case by case approach to avoid approach-related vascular complications, but the general relationships reported in this study can guide side of approach.

A prospective study of Autologous Growth Factors (AGF) in lumbar interbody fusion.

BACKGROUND: Numerous preclinical and clinical studies have reported on the use of platelet concentrates to promote tissue healing. The results in spinal fusion applications are limited and controversial. PURPOSE: The purpose of the current prospective clinical cohort study is to assess the effect of Autologous Growth Factors (AGF) on lumbar interbody fusion with specific attention paid to determination of clinical and radiographic outcomes. STUDY DESIGN/SETTING: Prospective clinical study PATIENT SAMPLE: Candidates for anterior-posterior lumbar fusion with diagnosis of degenerative disc disease and/or up to grade I spondylolytic spondylolisthesis based on positive provocative discography. OUTCOME MEASURES: Clinical (visual analogue pain scale/functional outcome assessment) and radiographic outcomes (fusion on computed tomography at 6 months and plain radiographs at 12 and 24 months). METHODS: Thirty-seven patients were assigned to standard anterior-posterior interbody fusion L2-S1 (single or two-level) using iliac crest bone graft (autograft group: 22 patients with 32 levels operated) or allograft combined with autogenous growth factors (AGF group: 15 patients with 25 levels operated). Radiographic outcomes were collected at 6 months postsurgery with computed tomography and at 12 and 24 months with plain radiographs. Pre- and postoperative clinical outcome measures included visual analog scores (VAS) for back and leg pain (0-10), SF-36 scores, and Oswestry disability determination. Average clinical and radiographic follow-up for the autograft group was 24.3+/-5.6 months (12-36 months) and AGF was 25.7+/-7.5 (6-40 months). RESULTS: Fusion incorporation at each end plate was determined at 56% in both autograft and AGF (p=NS) patients based on computed tomography at 6 months with minimal subsidence noted and no direct correlation between the incidence or degree of cage subsidence and bone graft technique. The 12- and 24-month radiographic results confirmed an 85% arthrodesis rate for the autograft patients, whereas the AGF patients had an 89% fusion rate (p=NS). Clinical outcomes were similar for both groups and no significant differences were noted for pain or functional outcome improvements. CONCLUSIONS: AGF combined with an allograft carrier is equivalent in radiographic and clinical outcomes to autograft in one- or two-level lumbar interbody fusion with supplemental posterior fixation and, thus, eliminates any morbidity from iliac crest bone graft harvesting. AGF combined with an appropriate carrier is a reasonable alternative to autograft and expensive bone induction technologies. Further research is still required to examine the optimum carriers, preparation and formulation, and platelet concentrations for this technology.

Is There an Association of Epidural Corticosteroid Injection With Postoperative Surgical Site Infection After Surgery for Lumbar Degenerative Spine Disease?

STUDY DESIGN: Retrospective study. OBJECTIVE: To assess the relation between exposure to epidural steroid injection (ESI) before surgery and occurrence of surgical site infection (SSI) for degenerative lumbar spine conditions. SUMMARY OF BACKGROUND DATA: The effect of local ESI on the occurrence of SSI is controversial. METHODS: Patients who underwent surgery for degenerative lumbar spine conditions at two centers between 2005 and 2015 were identified. Primary outcome measure was SSI within 90 days requiring surgical intervention. RESULTS: A total of 5311 patients (age 57 ±â€Š16 years) were analyzed of which 945 (18%) had at least one ESI within 90 days of surgery. One hundred thirty-four (2.5%) patients developed an SSI requiring reoperation. No association of exposure or dose-response relationship was identified between ESI and SSI for any of the time periods (90-, 30-, and 30-90-day). Five (1.7%) of the 290 patients who had at least one ESI within 30 days before surgery had a postoperative infection compared to 129 (2.6%) of the 5021 in the non-ESI group (unadjusted odds ratio: 0.67, 95% CI: 0.27-1.64, P = 0.376). Fifteen (2.0%) of the 761 patients who had at least one ESI within 30 to 90 days before surgery had a postoperative infection, compared to 119 (2.6%) of the 4550 in the non-ESI group (unadjusted odds ratio: 0.75, 95% CI: 0.44-1.29, P = 0.296). CONCLUSION: In this retrospective study we investigated whether an ESI and its timing influences the postoperative risk of an SSI. We found no association-exposure or dose-response relationship-between ESI and postoperative infection, even after adjusting for potential confounders, for any of the time periods (90-, 30-, and 30-90-day ESI). In addition, we did find that longer hospital stay, greater EBL, posterior approach, and drain placement were associated with higher infection rates.Level of Evidence: 3.

Carrier materials for spinal fusion.

BACKGROUND CONTEXT: The rise in spinal fusion procedures has led to an increase in the available number and variety of bone graft substitutes. As our understanding of the biologic processes that influence bony fusion has improved, appreciation for the role of the carrier material involved in bone grafts has also increased. PURPOSE: The abundance of products available leaves a surgeon with many choices. Knowledge of the current advances will allow for more critical review of the literature and improved decision making when choosing bone graft materials. STUDY DESIGN/SETTING: Review of the English-language literature. METHODS: A critical review of basic science, animal and human studies that investigate the types and role of carrier materials used in spine surgery. RESULTS: The myriad of carrier material available to the spine surgeon is related to the many options in bone graft material. Allograft is an important osteoconductive agent but has its disadvantages especially in regard to disease transmission and immunogenicity. Collagen in various forms is an effective carrier for bone morphogenic protein and autogenous stem cells and can be easily combined with other bone graft materials. Synthetic options include hydroxyapatite and calcium phosphate ceramic materials with different formulations; all are osteoconductive only but can be combined with osteoinductive and/or osteogenic components. Bioabsorbable carriers are effective for use with bone morphogenic protein and can also be used in multiple forms and settings. CONCLUSIONS: Many bone graft carriers exist, and multiple studies have shown their efficacy. It appears that no one carrier is ideal but each situation might influence the choice of one carrier over another.

Rheumatoid arthritis: evaluation and surgical management of the cervical spine.

BACKGROUND CONTEXT: Rheumatoid arthritis is a debilitating polyarthropathic degenerative condition. Eighty-six percent of patients with rheumatoid arthritis have cervical spine involvement. Often these lesions are clinically asymptomatic or symptoms are erroneously attributed to peripheral manifestation of the patient's rheumatoid disease. Because these lesions are common and missed diagnosis can result in death, early recognition is vital. PURPOSE: The purpose of this literature review is to identify common lesions present in the rheumatoid neck and review diagnostic methods as well as treatment options for those requiring surgical intervention. STUDY DESIGN: A review of the English medical literature with focus on more recent studies on the presentation, diagnosis, management, surgical treatment and clinical outcomes of rheumatoid arthritis of the cervical spine. METHODS: A comprehensive literature review of the English medical literature obtained through Medline up to November 2003 was performed identifying relevant and more recent articles that addressed the presentation, evaluation, surgical management and outcomes of rheumatoid patients with cervical spine involvement. RESULTS: If left untreated, a large percentage of rheumatoid patients with cervical spine involvement progress toward complex instability patterns resulting in significant morbidity and mortality. Once myelopathy occurs, prognosis for neurologic recovery and long-term survival is poor. In properly selected patients, anterior and/or posterior cervical procedures can prevent neurologic injuries and preserve remaining function. CONCLUSION: Cervical spine involvement in the rheumatoid patient is common and progressive. Early diagnosis and treatment is imperative; however, surgical intervention should be considered carefully because associated morbidity and mortality is high.

The effect of osteogenic protein-1 in instrumented and noninstrumented posterolateral fusion in rabbits.

BACKGROUND CONTEXT: The use of rigid instrumentation combined with bone graft makes intuitive sense given the requirements for vascular ingrowth, bone formation and a stable environment for the cellular events of healing to develop. However, with the advances of potent osteoinductive growth factors, the role of internal fixation may come into question. Whether bone morphogenic proteins (BMPs) would benefit from a more "stable" spinal segment for bone production and modeling remains unknown. In addition, it is unknown whether BMP and rigid fixation may have an additive effect on fusion healing. PURPOSE: This study is proposed to test the hypothesis that rigid fixation in the lumbar spine would be advantageous to achieve fusion for autogenous bone grafting, but fusion would occur regardless of fixation with the use of osteogenic protein (OP)-1. STUDY DESIGN/SETTING: A histologic and radiographic analysis of BMP in a rabbit lumbar fusion model. METHODS: Thirty-two rabbits were randomized into four groups: 1) control animals: in situ posterolateral L5-L6 arthrodesis using autogenous iliac crest bone graft; 2) fixation group: posterolateral arthrodesis L5-L6 with autogenous bone graft and interspinous fixation; 3) OP-1 group: in situ posterolateral L5-L6 arthrodesis using OP-1 and 4) combined OP-1 and fixation group. Radiographic fusion analysis was performed with computed tomography scans at 3 and 12 weeks after surgery. Decalcified histology was performed to assess tissue morphology and cellularity. RESULTS: Minimal evidence of fusion was noted at 3 weeks with autograft or OP-1. By 12 weeks, all OP-1-treated animals had solid fusion, whereas no fusion was noted in autograft animals. The addition of fixation slightly increased radiographic fusion at 3 weeks in autograft and OP-1 groups but did not affect OP-1 animals at 12 weeks where all were fused. Decalcified histologic results confirmed the proliferative bone formation noted with OP-1 and the variable cellular response with autograft. CONCLUSIONS: The results of the present study suggest that the osteoinductive effect of OP-1 may be only minimally enhanced early in the bone healing process but does not appear to be affected in the long term by spinal fixation in the rabbit intertransverse fusion model. Fixation appeared to enhance early fusion in the autograft group.

The association between preoperative spinal cord rotation and postoperative C5 nerve palsy.

BACKGROUND: C5 nerve palsy is a known complication of cervical spine surgery. The development and etiology of this complication are not completely understood. The purpose of the present study was to determine whether rotation of the cervical spinal cord predicts the development of a C5 palsy. METHODS: We performed a retrospective review of prospectively collected spine registry data as well as magnetic resonance images. We reviewed the records for 176 patients with degenerative disorders of the cervical spine who underwent anterior cervical decompression or corpectomy within the C4 to C6 levels. Our measurements included area for the spinal cord, space available for the cord, and rotation of the cord with respect to the vertebral body. RESULTS: There was a 6.8% prevalence of postoperative C5 nerve palsy as defined by deltoid motor strength of ≤ 3 of 5. The average rotation of the spinal cord (and standard deviation) was 2.8° ± 3.0°. A significant association was detected between the degree of rotation (0° to 5° versus 6° to 10° versus ≥ 11°) and palsy (point-biserial correlation = 0.94; p < 0.001). A diagnostic criterion of 6° of rotation could identify patients who had a C5 palsy (sensitivity = 1.00 [95% confidence interval, 0.70 to 1.00], specificity = 0.97 [95% confidence interval, 0.93 to 0.99], positive predictive value = 0.71 [95% confidence interval, 0.44 to 0.89], negative predictive value = 1.00 [95% confidence interval, 0.97 to 1.00]). CONCLUSIONS: Our evidence suggests that spinal cord rotation is a strong and significant predictor of C5 palsy postoperatively. Patients can be classified into three types, with Type 1 representing mild rotation (0° to 5°), Type 2 representing moderate rotation (6° to 10°), and Type 3 representing severe rotation (≥ 11°). The rate of C5 palsy was zero of 159 in the Type-1 group, eight of thirteen in the Type-2 group, and four of four in the Type-3 group. This information may be valuable for surgeons and patients considering anterior surgery in the C4 to C6 levels.

Efficacy of silicate-substituted calcium phosphate ceramic in posterolateral instrumented lumbar fusion.

STUDY DESIGN/SETTING: Retrospective review of a consecutive, nonrandomized series operated on by 2 surgeons. OBJECTIVE: To evaluate the clinical and radiographic effectiveness of a silicated hydroxyapatite ceramic as a bone graft substitute in a series of patients undergoing posterolateral instrumented lumbar fusion. SUMMARY OF BACKGROUND DATA: Newer-generation synthetic ceramics have been refined to maximize their host-graft interaction and stimulation of new tissue formation, including silicate-substitution. METHODS: An independent radiologist interpreted the computed tomography images at 6, 12, and 24 months after surgery. Forty-two patients with 1- or 2-level lumbar degenerative disorders underwent posterior laminectomy (when indicated) and posterolateral fusion with instrumentation. Surgical levels included 15 patients who underwent 2-level and 27 single-level fusion procedures (57 levels operated on in total). RESULTS: The average back pain scores improved from 5.6 ± 2.5 preoperative to 2.1 ± 2.5 at follow-up (P < 0.05). Similar results were seen with leg pain improvement from 5.8 ± 2.5 to 1.4 ± 1.9 (P < 0.05). At 6 months, 35% of levels revealed fusion, which increased to 76.2% and 76.5% at 12 and 24 months, respectively. No evidence of ectopic bone formation or osteolysis was noted. CONCLUSION: In this study, a silicated calcium phosphate-based ceramic has been shown to be effective as a graft substitute and eliminate the need for autogenous iliac crest bone graft. The results confirm radiographic healing in posterolateral instrumented lumbar fusion at 24-months follow-up. The clinical outcomes also substantiate significant pain improvement consistent with published data in the literature compared with other bone graft alternatives.

Association of catechol-O-methyltransferase genetic variants with outcome in patients undergoing surgical treatment for lumbar degenerative disc disease.

BACKGROUND CONTEXT: Surgical treatment for lumbar degenerative disc disease (DDD) has been associated with highly variable results in terms of postoperative pain relief and functional improvement. Many experts believe that DDD should be considered a chronic pain disorder as opposed to a degenerative disease. Genetic variation of the catechol-O-methyltransferase (COMT) gene has been associated with variation in human pain sensitivity and response to analgesics in previous studies. PURPOSE: To determine whether genetic variation of COMT is associated with clinical outcome after surgical treatment for DDD. STUDY DESIGN: Prospective genetic association study. PATIENT SAMPLE: Sixty-nine patients undergoing surgical treatment for lumbar DDD. Diagnosis was based on documentation of chronic disabling low back pain (LBP) present for a minimum of 6 months and unresponsive to supervised nonoperative treatment, including activity modification, medication, physical therapy, and/or injection therapy. Plain radiographs and magnetic resonance imaging revealed intervertebral disc desiccation, tears, and/or collapse without focal herniation, nerve root compression, stenosis, spondylolisthesis, spondylolysis, or alternative diagnoses. OUTCOME MEASURES: Oswestry Disability Index (ODI) and visual analog score (VAS) for LBP. METHODS: Surgical treatment included 65 instrumented fusions and four disc arthroplasty procedures. All patients completed preoperative and 1-year postoperative ODI questionnaires. DNA was extracted from a sample of venous blood, and genotype analysis was performed for five common COMT single nucleotide polymorphisms (SNPs). Potential genetic association between these COMT SNPs and the primary outcome variable, 1-year change in ODI, was investigated using both single-marker and haplotype association analyses. Association with VAS scores for LBP was analyzed as a secondary outcome variable. RESULTS: Single-marker analysis revealed that the COMT SNP rs4633 was significantly associated with greater improvement in ODI score 1 year after surgery (p=.03), with individuals homozygous for the less common "T" allele demonstrating the largest improvement in ODI. Haplotype analysis of four COMT SNPs, rs6269, rs4633, rs4818, and rs4680, also identified a common haplotype "ATCA" (haplotype frequency of 39.3% in the study population) associated with greater improvement in ODI (p=.046). The greatest mean improvement in ODI was observed in patients homozygous for the "ATCA"COMT haplotype. A nonsignificant trend was observed between SNP rs4633 and greater improvement in VAS score for LBP. CONCLUSIONS: This is the first study to report an association between surgical treatment success in DDD patients and genetic variation in the putative pain sensitivity gene COMT. These findings require replication in other DDD populations but suggest that genetic testing for pain-relevant genetic markers such as COMT may provide useful clinical information in terms of predicting outcome after surgery for patients diagnosed with DDD.

Polymorphic variation of the guanosine triphosphate cyclohydrolase 1 gene predicts outcome in patients undergoing surgical treatment for lumbar degenerative disc disease.

STUDY DESIGN: Prospective observational study. OBJECTIVE: To determine whether polymorphic variations of the guanosine triphosphate (GTP) cyclohydrolase 1 gene (GCH1) are associated with different outcomes in patients undergoing surgical treatment for lumbar degenerative disc disease (DDD). SUMMARY OF BACKGROUND DATA: GCH1, the gene encoding the rate-limiting enzyme in tetrahydrobiopterin synthesis, has been strongly implicated as a determinant of pain experience in previous animal and human studies. METHODS.: A total of 69 patients undergoing surgical treatment for lumbar DDD were prospectively enrolled. Genomic DNA was extracted from a venous blood sample, and DNA sequence analysis was performed of GCH1. Surgery included 65 instrumented fusions and 4 disc arthroplasty procedures. Patients were observed prospectively for 1 year following surgery. Allelic and genotype frequencies were calculated for each of 14 single nucleotide polymorphisms (SNPs). One-year postoperative Oswestry Disability Index (ODI) scores were compared to preoperative scores and the absolute change in ODI score was used to perform genetic association analyses on the basis of both individual SNP markers as well as commonly observed haplotypes for the entire gene sequence. RESULTS: Single marker analysis revealed 1 SNP (rs998259; minor allele T) that was significantly associated with improvement in both absolute ODI score (P = 0.030) and Numerical Rating Scale back pain scores (P = 0.033) following surgery. Haplotype analysis identified a common GCH1 haplotype ("CACTTGTTTGAC") with a sample frequency of 12.3%, which was highly associated with improvement in absolute ODI score (P = 0.04). This haplotype frequency reflects the existence of both heterozygous and homozygous individuals in the study population. The presence of 1 unit of this haplotype was associated with an improvement in postoperative ODI score of 15.34 relative to the absence of this haplotype (P = 0.04). CONCLUSION: Preliminary results from this pilot genetic study of patients undergoing surgery for DDD suggests that the T allele at rs998259 of GCH1 may be associated with improved outcomes 1 year following surgery.

Prospective study of iliac crest bone graft harvest site pain and morbidity.

BACKGROUND CONTEXT: Morbidity associated with autologous bone graft harvest is an important factor in determining the utility of expensive alternatives such as recombinant bone morphogenic protein. The most frequently reported complication associated with graft harvest is chronic pain. PURPOSE: To prospectively determine the degree of pain and morbidity associated with autologous iliac crest bone graft harvest and its effect on activities of daily living. STUDY DESIGN: Prospective observational cohort study. PATIENT SAMPLE: One hundred ten adult patients undergoing elective posterior lumbar spinal fusion surgery involving autologous iliac crest bone graft harvest. OUTCOME MEASURES: Patient self-reported Visual Analog Scale (VAS) scores for pain and a study-specific questionnaire regarding activities of daily living. METHODS: One hundred ten patients were prospectively enrolled. Postoperative VAS scores (0-100) for harvest site pain were obtained at 6-week, 6- and 12-month follow-up. Patients completed a 12-month questionnaire regarding the persistence of specific symptoms and resulting limitation of specific activities. RESULTS: One hundred four patients were available for 1-year follow-up. Mean VAS pain scores (scale 0-100) at 6 weeks, 6 and 12 months were 22.7 (standard deviation [SD], 25.9), 15.9 (SD, 21.5), and 16.1 (SD, 24.6), respectively. At 12 months, 16.5% reported more severe pain from the harvest site than the primary surgical site, 29.1% reported numbness, and 11.3% found the degree of numbness bothersome, whereas 3.9% were bothered by scar appearance. With respect to activity limitations resulting from harvest site pain at 1 year, 15.1% reported some difficulty walking, 5.2% with employment, 12.9% with recreation, 14.1% with household chores, 7.6% with sexual activity, and 5.9% irritation from clothing. CONCLUSIONS: There is a significant rate of persistent pain and morbidity from iliac crest bone graft harvest when associated with elective spine surgery. Mean pain scores progressively decline over the first postoperative year. Nevertheless, harvest site pain remains functionally limiting in a significant percentage of patients 1 year after surgery. Rates of functional limitation are higher than previously reported and may be because of increased sensitivity of the prospective study design and targeted investigation of these specific symptoms. Validity of these findings is necessarily limited by patient ability to discriminate harvest site pain from alternative sources of back and buttock pain.

Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up.

BACKGROUND CONTEXT: The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date. PURPOSE: The purpose of this study was to compare the safety and effectiveness at the five-year follow-up time point of lumbar total disc replacement using the CHARITE artificial disc (DePuy Spine, Raynham, MA) with that of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disc disease from L4 to S1, unresponsive to nonoperative treatment. STUDY DESIGN/SETTING: Randomized controlled trial-five-year follow-up. PATIENT SAMPLE: Ninety CHARITE patients and 43 BAK patients. OUTCOME MEASURES: Self-reported measures: visual analog scale (VAS); validated Oswestry disability index (ODI version 1.0); Short-Form 36 Questionnaire, and patient satisfaction. Physiologic measures: radiographic range of motion, disc height, and segmental translation. Functional measures: work status. METHODS: Of the 375 subjects enrolled in the CHARITE IDE trial, 277 were eligible for the five-year study and 160 patients thereof completed the five-year follow-up. The completers included 133 randomized patients. Overall success was defined as improvement> or =15 pts in ODI vs. baseline, no device failure, absence of major complications, and maintenance or improvement of neurological status. Additional clinical outcomes included an ODI questionnaire as well as VAS, SF-36, and patient satisfaction surveys. Work status was tracked for all patients. Safety assessments included occurrence and severity of adverse events and device failures. Radiographic analyses such as index- and adjacent-level range of motion, segmental translation, disc height, and longitudinal ossification were also carried out. RESULTS: Overall success was 57.8% in the CHARITE group vs. 51.2% in the BAK group (Blackwelder's test: p=0.0359, Delta=0.10). In addition, mean changes from baseline for ODI (CHARITE: -24.0 pts vs. BAK: -27.5 pts), VAS pain scores (CHARITE: -38.7 vs. BAK: -40.0), and SF-36 questionnaires (SF-36 Physical Component Scores [PCS]: CHARITE: 12.6 pts vs. BAK: 12.3 pts) were similar across groups. In patient satisfaction surveys, 78% of CHARITE patients were satisfied vs. 72% of BAK patients. A total of 65.6% patients in the CHARITE group vs. 46.5% patients in the BAK group were employed full-time. This difference was statistically significant (p=0.0403). Long-term disability was recorded for 8.0% of CHARITE patients and 20.9% of BAK patients, a difference that was also statistically significant (p=0.0441). Additional index-level surgery was performed in 7.7% of CHARITE patients and 16.3% of BAK patients. Radiographic findings included operative and adjacent-level range of motion (ROM), intervertebral disc height and segmental translation. At the five-year follow-up, the mean ROM at the index level was 6.0 degrees for CHARITE patients and 1.0 degrees for BAK patients. Changes in disc height were also similar for both CHARITE and BAK patients (0.7 mm for both groups, p=0.9827). Segmental translation was 0.4 and 0.8mm in patients implanted with CHARITE at L4-L5 vs. L5-S1, respectively, and 0.1mm in BAK patients. CONCLUSIONS: The results of this five-year, prospective, randomized multicenter study are consistent with the two-year reports of noninferiority of CHARITE artificial disc vs. ALIF with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, CHARITE patients reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK patients. Radiographically, the ROMs at index- and adjacent levels were not statistically different from those observed at two-years postsurgery.