Scott Tromanhauser

Publications (14) View all

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

  Feng Dai, Inna Belfer, Carolyn E Schwartz, Robert Banco, Julia F Martha, Hocine Tighioughart, Scott G Tromanhauser, Louis G Jenis, David H Kim
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  ABSTRACT: 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. To determine whether genetic variation of COMT is associated with clinical outcome after surgical treatment for DDD. Prospective genetic association study. 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. Oswestry Disability Index (ODI) and visual analog score (VAS) for LBP. 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. 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. 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.
  The spine journal: official journal of the North American Spine Society 11/2010; 10(11):949-57. · 2.90 Impact Factor
• Article: Polymorphic variation of the guanosine triphosphate cyclohydrolase 1 gene predicts outcome in patients undergoing surgical treatment for lumbar degenerative disc disease.

  David H Kim, Feng Dai, Inna Belfer, Robert J Banco, Julia F Martha, Hocine Tighiouart, Scott G Tromanhauser, Louis G Jenis, David J Hunter, Carolyn E Schwartz
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  ABSTRACT: Prospective observational study. 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). 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. 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). 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.
  Spine 10/2010; 35(21):1909-14. · 2.08 Impact Factor
• Source

  Available from: Fred H Geisler

  Article: 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.

  Richard D Guyer, Paul C McAfee, Robert J Banco, Fabian D Bitan, Andrew Cappuccino, Fred H Geisler, Stephen H Hochschuler, Richard T Holt, Louis G Jenis, Mohamed E Majd, John J Regan, Scott G Tromanhauser, Douglas C Wong, Scott L Blumenthal
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  ABSTRACT: 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. 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. Randomized controlled trial-five-year follow-up. Ninety CHARITE patients and 43 BAK patients. 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. 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. 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. 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.
  The spine journal: official journal of the North American Spine Society 09/2008; 9(5):374-86. · 2.90 Impact Factor
• Article: The spine service line: optimizing patient-centered spine care.

  Brian Kwon, Scott G Tromanhauser, Robert J Banco
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  ABSTRACT: Literature review and expert opinion on the delivery of spine care. Our objective was to describe the goals of a spine service line and encourage the implementation of a systems-based approach to spine care. The benefits to patients and institutions are discussed. Spine care delivery and its associated costs are rising rapidly. There exists tremendous variability in the rate at which it is delivered. With so many options for spine care, patients are subject to decisions of providers with disparate backgrounds and expertise. This leads to inefficiencies in diagnosis and delivery of care. All these factors lead to increased costs of care of uncertain benefit and increased burden to society. The literature on systems-based approaches to spine care was reviewed. Those relating to health care policy and recent clinical trials were emphasized. How these data work in a systems-based approach was described. Additionally, the authors' experiences working in and within a structured spine care system were related and included. We describe 3 spine care episodes and where each possesses particular inefficiencies that lead to increased costs without added value to the delivery of spine care. The primary episode is the start of the patient's painful incident. We propose a more uniform guidelines-based approach using appropriate (and similar) diagnostic testing and education. The secondary phase of care can be costly as more sophisticated diagnostic and treatment methods are instituted. Within an institution or spine care practice, matching the level of providers with the patients at this phase of care would lead to better utilization of resources. Additionally, benefits to the institution would be greater if managed properly. The third phase of care focuses on intervention with long-term benefits. We discuss the use of registry like data and analysis of outcomes on these patients. Agreement within a group or institution on operative indications would allow for more uniform analysis of these outcomes. Alternative revenue streams are also discussed. The patient with spinal disease is in need of high-quality, proven, and efficient care. Using a systems-based approach, we can minimize escalating costs associated with inefficient health care and delivery. Cooperation between physicians and institutions is critical to this process.
  Spine 06/2007; 32(11 Suppl):S44-8. · 2.08 Impact Factor
• Article: Computed tomography evaluation of superior-segment facet-joint violation after pedicle instrumentation of the lumbar spine with a midline surgical approach.

  Ali Moshirfar, Louis G Jenis, Leo R Spector, Patrick J Burke, Elena Losina, Jeffrey N Katz, Frank F Rand, Scott G Tromanhauser, Robert J Banco
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  ABSTRACT: Retrospective study. To determine the frequency of pedicle screw violation of superior nonfused facet joints adjacent to the most cephalad pedicle screws after a midline approach for lumbar fusion. Facet-joint violations have been evaluated in patients undergoing lumbar pedicle screw instrumentation and fusion with a Wiltse muscle-splitting approach, but not via the more common midline approach. Between 1995 and 2003, 204 patients underwent this procedure. Computed tomography scans (within 1 year postsurgery) were evaluated independently for superior facet-joint violation. chi tests were used to examine bivariate associations of superior level facet-joint violation, patient age, construct level, diagnosis, and revision status for significance (P < or = 0.05). Superior-level facet-joint violation occurred in 24% of patients and 15% of screws, twice as often on the left side (P = 0.0396) than on the right, more frequently in single than in multiple-level procedures (P < 0.0001), and most frequently with the most cephalad screws at L5 (48%). We found no significant associations between violation rates and other designated parameters. The left side, single-level fusion, and most cephalad pedicle screws at L5 are targets for interventions to reduce pedicle violations in this procedure.
  Spine 11/2006; 31(22):2624-9. · 2.08 Impact Factor