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1.
Adv Orthop ; 2015: 501202, 2015.
Article in English | MEDLINE | ID: mdl-25653880

ABSTRACT

Background Context. Products that can reduce development of epidural fibrosis may reduce risk for ongoing pain associated with development of scar tissue and make subsequent epidural reexploration easier. Purpose. To evaluate the use of dehydrated human amnion/chorion membrane (dHACM) on the formation of soft tissue scarring in the epidural space. Study Design. Case series. Patient Sample. Five patients having transforaminal lumbar interbody lumbar fusion (TLIF) with posterior instrumentation and implantation of dHACM in the epidural space and subsequent epidural reexploration. Outcome Measures. Degree of scar tissue adjacent to the epidural space at reexploration. Intraoperative and postoperative complications related to dHACM and patient reported outcomes. Methods. The degree of scar tissue adjacent to the epidural space was assessed during the reexploration surgery. Patients' outcomes were collected using standard validated questionnaires. Results. Four of 5 cases had easily detachable tissue during epidural reexploration. Angiolipoma of 10% was noted in 1 case and 5% in 2 cases. Significant improvements in patient reported outcomes were observed. No intraoperative or postoperative complications occurred. Conclusions. Our findings suggest that dHACM implant during TLIF may have favorable effects on epidural fibrosis and is well tolerated. Further studies with larger cohorts are required to prove our results.

2.
J Neuroimmune Pharmacol ; 8(1): 274-86, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23188522

ABSTRACT

Lumbar spinal stenosis (LSS) is the leading cause of morbidity and mortality worldwide. LSS pathology is associated with secondary injury caused by inflammation, oxidative damage and cell death. Apart from laminectomy, pharmacological therapy targeting secondary injury is limited. Statins are FDA-approved cholesterol-lowering drug. They also show pleiotropic anti-inflammatory, antioxidant and neuroprotective effects. To investigate the therapeutic efficacy of simvastatin in restoring normal locomotor function after cauda equina compression (CEC) in a rat model of LSS, CEC injury was induced in rats by implanting silicone gels into the epidural spaces of L4 and L6. Experimental group was treated with simvastatin (5 mg/kg body weight), while the injured (vehicle) and sham operated (sham) groups received vehicle solution. Locomotor function in terms of latency on rotarod was measured for 49 days and the threshold of pain was determined for 14 days. Rats were sacrificed on day 3 and 14 and the spinal cord and cauda equina fibers were extracted and studied by histology, immunofluorescence, electron microscopy (EM) and TUNEL assay. Simvastatin aided locomotor functional recovery and enhanced the threshold of pain after the CEC. Cellular Infiltration and demyelination decreased in the spinal cord from the simvastatin group. EM revealed enhanced myelination of cauda equina in the simvastatin group. TUNEL assay showed significantly decreased number of apoptotic neurons in spinal cord from the simvastatin group compared to the vehicle group. Simvastatin hastens the locomotor functional recovery and reduces pain after CEC. These outcomes are mediated through the neuroprotective and anti-inflammatory properties of simvastatin. The data indicate that simvastatin may be a promising drug candidate for LSS treatment in humans.


Subject(s)
Cauda Equina/pathology , Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacology , Simvastatin/pharmacology , Spinal Cord Compression/drug therapy , Spinal Cord Compression/pathology , Spinal Stenosis/drug therapy , Spinal Stenosis/pathology , Analgesics/pharmacology , Animals , Anti-Inflammatory Agents/pharmacology , Female , Hyperalgesia/prevention & control , Image Processing, Computer-Assisted , Immunohistochemistry , In Situ Nick-End Labeling , Locomotion/physiology , Magnetic Resonance Imaging , Microscopy, Electron, Transmission , Neuroprotective Agents/pharmacology , Pain Measurement/drug effects , Physical Stimulation , Postural Balance/drug effects , Rats , Rats, Sprague-Dawley
4.
Spine J ; 12(11): e1-4, 2012 Nov.
Article in English | MEDLINE | ID: mdl-23131581

ABSTRACT

BACKGROUND CONTEXT: Percutaneous intradiscal therapies are gaining popularity as a regenerative treatment option for spinal disc degeneration. The risks, benefits, and possible complications associated with such procedures have been poorly defined. As these procedures are performed with increasing frequency, the likelihood that clinicians will be faced with significant complications also increases. PURPOSE: The purpose of this study is to describe a significant complication of a percutaneous intradiscal bone marrow and adipose tissue transplantation for symptomatic lumbar disc degeneration. STUDY DESIGN: The study design is a case report. METHODS: Two weeks after an injection of adipose cells, bone marrow aspirate and plasma into his L3-L4 and L5-S1 lumbar discs, a 64-year-old patient presented to the emergency room with cauda equina syndrome, fever, and back pain. Magnetic resonance imaging diagnosed L3-L4 disc extrusion, discitis with osteomyelitis, and epidural abscess, resulting in emergency decompressive surgery. An epidural abscess was drained, extruded disc material was removed, and cultures obtained. Five days later, once afebrile on antibiotics, he underwent a definitive interbody arthrodesis and stabilization. RESULTS: Cauda equina syndrome resolved, osteomyelitis (methicillin-resistant Staphylococcus epidermidis) was treated, and instrumented arthrodesis stabilized the involved segment. CONCLUSIONS: Complications associated with the intradiscal injection of agents, such as stem cells, fibrin glue, adipose tissue, or bone marrow, have been poorly defined. Given the nature of the degenerating disc, serious adverse events, including discitis, osteomyelitis, and extrusion of disc contents, may occur.


Subject(s)
Diskectomy, Percutaneous/adverse effects , Epidural Abscess/etiology , Intervertebral Disc Degeneration/therapy , Polyradiculopathy/etiology , Postoperative Complications , Adipose Tissue/transplantation , Bone Marrow Transplantation/methods , Epidural Abscess/pathology , Humans , Intervertebral Disc Degeneration/pathology , Lumbar Vertebrae , Magnetic Resonance Imaging , Male , Middle Aged , Osteomyelitis/etiology , Osteomyelitis/pathology , Polyradiculopathy/pathology
5.
Neurosci Med ; 3(3): 294-305, 2012 Sep 25.
Article in English | MEDLINE | ID: mdl-23997981

ABSTRACT

Lumbar spinal stenosis (LSS) causes ischemia, inflammation, demyelination and results in dysfunction of the cauda equina (CE), leading to pain and locomotor functional deficits. We investigated whether exogenous administration of S-nitrosoglutathione (GSNO), an endogenous redox modulating anti-neuroinflammatory agent, hastens functional recovery in a CE compression (CEC) rat model. CEC was induced in adult female rats by the surgical implantation of two silicone blocks within the epidural spaces of L4-L6 vertebrae. GSNO (50 µg/kg body weight) was administered by gavage 1 h after the injury, and the treatment was continued daily thereafter. GSNO induced change in the pain threshold was evaluated for four days after the compression. Tissue analyses and locomotor function evaluation were carried out at two weeks and four weeks after the CEC respectively. GSNO significantly improved motor function in CEC rats as evidenced by an increased latency on rotarod compared with vehicle-treated CEC rats. CEC induced hyperalgesia was decreased by GSNO. GSNO also increased the expression of VEGF, reduced cellular infiltration (H&E staining) and apoptotic cell death (TUNEL assay), and hampered demyelination (LFB staining and g-ratio). These data demonstrate that administration of GSNO after CEC decreased inflammation, hyperalgesia and cell death leading to improved locomotor function of CEC rats. The therapeutic potential of GSNO observed in the present study with CEC rats suggests that GSNO is a candidate drug to test in LSS patients.

6.
Adv Orthop ; 2011: 176497, 2011.
Article in English | MEDLINE | ID: mdl-21994890

ABSTRACT

Object. The implantation of interbody fusion cages allows for the restoration of disc height and the enlargement of the neuroforaminal space. The purpose of this study was to compare the extent of subsidence occurring after conventional cage placement compared to a novel wider cage placement technique. Methods. This study is a retrospective evaluation of radiographs of patients who underwent stand-alone single level anterior lumbar interbody fusion with lordotic titanium cages and rhBMP-2. Fifty-three patients were evaluated: 39 patients had wide cage placement (6 mm interdevice distance) and 14 had narrow cage placement (2 mm interdevice distance). Anterior and posterior intervertebral disc space heights were measured post-operatively and at follow-up imaging. Results. The decrease in anterior intervertebral disc space height was 2.05 mm versus 3.92 mm (P < .005) and 1.08 mm versus 3.06 mm in posterior disc space height for the wide cage placement and the narrow cage placement respectively. The proportion of patients with subsidence greater than 2 mm was 41.0% in the wide cage patients and 85.7% for the narrow cage patients (P < .005). Conclusions. The wider cage placement significantly reduced the amount of subsidence while allowing for a greater exposed surface area for interbody fusion.

7.
J Inflamm (Lond) ; 7: 17, 2010 Apr 19.
Article in English | MEDLINE | ID: mdl-20403180

ABSTRACT

BACKGROUND: Urinary bladder and renal dysfunction are secondary events associated with spinal cord injury (SCI) in humans. These secondary events not only compromise quality of life but also delay overall recovery from SCI pathophysiology. Furthermore, in experimental models the effects of SCI therapy on bladder and renal functions are generally not evaluated. In this study, we tested whether simvastatin improves bladder and renal functions in a rat model of experimental SCI. METHODS: SCI was induced by controlled contusion of T9-T10 in adult female rats. Simvastatin (5 mg/Kg body weight) was administered at two hours after SCI and repeated every 24 hours until the end point. Simvastatin-treated SCI animals (simvastatin group) were compared with vehicle-treated SCI animals (vehicle group) in terms of the Basso Beattie Bresnahan score, tissue morphology, cell death, and bladder/renal functions. RESULTS: The urinary bladder of vehicle animals showed a 4.3-fold increase in size and a 9-fold increase in wet weight compared to sham animals. Following SCI, the urine to plasma osmolality ratio increased initially but decreased 1 week after SCI. Hematoxylin and eosin staining of bladder tissue showed transitional epithelial hyperplasia, degeneration of lamina propria, and enlargement of tunica adventia in addition to detrusor muscle hypertrophy. Rats treated with simvastatin for 14 days displayed remarkable recovery by showing decreased bladder size and maintenance of a normal urine/plasma osmolality ratio, in addition to improved locomotion. The muscularis layer of the bladder also regained its compact nature in simvastatin animals. Moreover, SCI-induced renal caspase-3 activity was significantly decreased in the simvastatin group indicating the ability of simvastatin to reduce the renal tubular apoptosis. CONCLUSION: Post-injury administration of simvastatin ameliorates bladder and renal dysfunction associated with SCI in rats.

8.
Spine J ; 10(4): 291-6, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20171937

ABSTRACT

BACKGROUND CONTEXT: Outcomes of spinal treatments are evaluated by clinical relevance: the proportion of patients who reach a minimum clinically important outcome change. Outcomes are evaluated through multiple measurements, and the inconsistency of outcome change across measurements is not known. PURPOSE: The primary purpose of this study was to illustrate outcome inconsistencies after spinal surgery. Secondary goals of this study were to develop an index of overall change that incorporates outcome inconsistencies, to relate the index of overall change to patients' global assessment and satisfaction with treatment, to relate the index of global change to an intuitively understandable outcome: the level of tolerable pain. STUDY DESIGN: This study is a review of prospectively collected patient-reported outcomes data. PATIENT SAMPLE: Four hundred sixty patients from a large multicenter database were chosen. Those patients were included in the sample because they had undergone lumbar surgery and had baseline and 1-year follow-up scores. Baseline and 1-year follow-up scores for Oswestry Disability Index (ODI), physical component summary (PCS) of the Medical Outcome Study Short Form-36 (SF-36), numerical back and leg pain scales, and 1-year scores for satisfaction with results were included in the study. OUTCOME MEASURES: The outcome measures of the study were preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item of the SF-36, and satisfaction with results scales. METHODS: Oswestry Disability Index, SF-36, and pain scales were administered before and 1 year after spinal surgery. Satisfaction with results questionnaires were administered 1 year after surgery. The following threshold values were previously established and were used to evaluate outcome changes: minimum clinically important difference (MCID), substantial clinical benefit (SCB), and standard error of the mean. The following proportions of patients were determined according to outcome changes: "deteriorated," "no change," "below MCID," "above MCID," and "above SCB." The consistency of outcome change was determined amongst the four outcome measures. An index of overall change was developed and related to patients' answers to the health transition item of the SF-36 and to the satisfaction with results scale. The overall change index was also compared with the tolerable pain level. RESULTS: Only 40.5% of patients report consistent outcome changes on all four measures. The overall change index was significantly correlated to the global change and satisfaction scale (rho=.67, p less than .001). The overall change index was clearly associated with the tolerable pain level. CONCLUSIONS: Efforts should be made to take into account the inconsistency of outcomes and to make clinical relevance more readily understandable by patients and clinicians.


Subject(s)
Back Pain/surgery , Outcome Assessment, Health Care , Patient Satisfaction , Spinal Diseases/surgery , Spinal Fusion , Data Interpretation, Statistical , Databases, Factual , Disability Evaluation , Female , Health Status , Humans , Lumbar Vertebrae/surgery , Male , Middle Aged , Pain Measurement , Pain, Postoperative , Quality of Life , Treatment Outcome
9.
Spine J ; 10(2): e5-9, 2010 Feb.
Article in English | MEDLINE | ID: mdl-20036621

ABSTRACT

BACKGROUND CONTEXT: Chondromyxoid fibroma (CMF) and aneurysmal bone cysts (ABCs) are rare bone tumors and even rarer in the spine. To date, no report has been made of CMF with secondary ABC in the cervical spine. PURPOSE: The purpose of this study was to describe the diagnosis and surgical treatment of a case of CMF with secondary ABC of C6, a rare occurrence in an uncommon location. STUDY DESIGN: The study design is a case report. METHODS: A 27-year-old woman presented with numbness with paresthesias of the right upper extremity. Diagnostic imaging revealed diffuse enlargement of the right C6 lamina extending into the pedicle and medial facet joint. Surgical treatment consisted of complete C6 laminectomy, total resection of the extradural cervical mass, posterior lateral fusion at C5-C7, and posterior segmental instrumentation from C5 to C7. Histopathology was consistent with CMF with secondary ABC. RESULTS: Laminectomy and instrumented segmental fusion provided an excellent clinical outcome. The instrumented fusion maintained the sagittal balance of the spine and stabilized across a complete facetectomy. The excision will likely avoid recurrence of the lesion. CONCLUSIONS: Treatment of CMF and ABC is challenging in the spine because of the proximity to neural structures. Aggressive surgical treatment makes recurrence less likely but creates the risk of spinal instability. Adequate surgical treatment needs to provide spinal stability.


Subject(s)
Bone Cysts, Aneurysmal/complications , Chondroma/complications , Fibroma/complications , Spinal Diseases/complications , Spinal Neoplasms/complications , Adult , Bone Cysts, Aneurysmal/pathology , Bone Cysts, Aneurysmal/surgery , Cervical Vertebrae/pathology , Cervical Vertebrae/surgery , Chondroma/pathology , Chondroma/surgery , Female , Fibroma/pathology , Fibroma/surgery , Humans , Magnetic Resonance Imaging , Spinal Diseases/pathology , Spinal Diseases/surgery , Spinal Fusion , Spinal Neoplasms/pathology , Spinal Neoplasms/surgery , Treatment Outcome
10.
Spine (Phila Pa 1976) ; 34(2): 161-6, 2009 Jan 15.
Article in English | MEDLINE | ID: mdl-19139666

ABSTRACT

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Perform a multivariate analysis to identify important predictors of poor outcome following anterior cervical discectomy and fusion. SUMMARY OF BACKGROUND DATA: Identifying prognostic factors is important to aid surgical decision-making and counseling of patients. Recent randomized control trials of disc arthroplasty devices have established a large cohort of patients treated with fusion and 2-year outcomes that allow analysis of prognostic factors. METHODS: The patient cohort was the fusion control patients (n = 488) from 2 randomized controlled studies of disc replacements. Surgical indications were recalcitrant single-level subaxial radiculopathy or myelopathy. The surgery included anterior discectomy and fusion with allograft and plate. Patients were assessed by neck and arm pain, neck disability index (NDI), SF-36, neurologic examination, and return to work. Overall clinical success was defined based on meeting all 4 of these criteria: >15-point improvement in NDI; maintained or improved neurologic examination; no serious adverse event related to the procedure; and no revision of the plate or graft. Patient's outcomes were recorded, at 3, 6, 12, and 24 months, with 77% follow-up at 24 months.The outcome variables for this analysis were overall clinical success and >15-point improvement in NDI. We studied the relationship between each of the outcome variables and 26 potential important variables including demographics, medical conditions, socioeconomic factors, and disease state. Two statistical models were used to explore the association between outcome variables and baseline measures: multivariate logistical regression of the full model with every prognostic variable included and the model with the variables selected by the stepwise selection procedure. RESULTS: In the full-model logistic analysis for overall success, worker's compensation and weak narcotic use were negative predictors while higher preoperative NDI score and normal sensory function were positive predictors. For NDI success, only the preoperative NDI scores (higher disability predictive of improvement) appeared to have strong influence on the outcome.In the stepwise regression model, preoperative normal sensory function was a positive predictor and worker's compensation a negative predictors of overall clinical success. Greater age, higher preoperative NDI score, and gainful employment were positive predictors and spinal litigation was a negative predictor of NDI success. CONCLUSION: We found that important predictors of outcome were work status, sensory function, involvement in litigation, and higher disability scores.


Subject(s)
Cervical Vertebrae/surgery , Diskectomy , Intervertebral Disc Displacement/surgery , Outcome Assessment, Health Care/methods , Spinal Fusion , Adult , Bone Plates , Cervical Vertebrae/diagnostic imaging , Cervical Vertebrae/pathology , Cohort Studies , Diskectomy/statistics & numerical data , Female , Humans , Intervertebral Disc Displacement/diagnostic imaging , Intervertebral Disc Displacement/pathology , Male , Middle Aged , Multivariate Analysis , Neck Pain/etiology , Neck Pain/physiopathology , Neck Pain/surgery , Prospective Studies , Radiculopathy/etiology , Radiculopathy/physiopathology , Radiculopathy/surgery , Radiography , Sensation/physiology , Spinal Fusion/statistics & numerical data , Transplantation, Homologous , Treatment Outcome , Workers' Compensation/statistics & numerical data
11.
J Bone Joint Surg Am ; 90(9): 1839-47, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18762642

ABSTRACT

BACKGROUND: Validated health-related quality-of-life measures have become important standards in the evaluation of the outcomes of lumbar spine surgery. However, there are few well-defined criteria for clinical success based on these measures. The minimum clinically important difference is an important demarcation, but it could be considered a floor value rather than a goal in defining clinical success. Therefore, we sought to define thresholds of substantial clinical benefit for commonly used health-related quality-of-life measures following lumbar spine arthrodesis. METHODS: Prospectively collected preoperative and one-year postoperative health-related quality-of-life measures from 357 patients who were managed with lumbar spine arthrodesis for the treatment of degenerative conditions were identified. Candidate substantial clinical benefit thresholds for the Short Form-36 physical component score, Oswestry Disability Index, and back and leg pain numeric rating scales were identified with use of receiver operating characteristic curve analysis. Receiver operating characteristic curves were used to discriminate between patients who reported being "much better" or "about the same" with use of the validated Short Form-36 health transition item and between those who reported being "mostly satisfied" or "unsure" with use of a nonvalidated but more surgery-specific satisfaction-with-results survey. For each health-related quality-of-life measure, three response parameters were used: net change, percent change, and raw score at the time of the one-year follow-up. RESULTS: Substantial clinical benefit thresholds for the Short Form-36 physical component score were a 6.2-point net improvement, a 19.4% improvement, or a final raw score of > or = 35.1 points. Substantial clinical benefit thresholds for the Oswestry Disability Index were an 18.8-point net improvement, a 36.8% improvement, or a final raw score of < 31.3 points. Substantial clinical benefit thresholds for the back pain and leg pain numeric rating scales were a 2.5-point net improvement or a final raw score of < 3.5 points. Substantial clinical benefit thresholds for percent change were 41.4% for the back pain numeric rating scale and 38.8% for the leg pain numeric rating scale. CONCLUSIONS: We believe that thresholds of substantial clinical benefit for commonly used health-related quality-of-life measures following lumbar spine arthrodesis are important as they describe a magnitude of change that the patient recognizes as a major improvement.


Subject(s)
Arthrodesis , Lumbar Vertebrae/surgery , Outcome Assessment, Health Care , Spinal Diseases/surgery , Adult , Aged , Aged, 80 and over , Disability Evaluation , Female , Humans , Male , Middle Aged , Pain Measurement , Patient Satisfaction , Prospective Studies , Quality of Life , ROC Curve , Surveys and Questionnaires
12.
Spine J ; 8(6): 998-1002, 2008.
Article in English | MEDLINE | ID: mdl-18280214

ABSTRACT

BACKGROUND CONTEXT: Computed tomography (CT) scan has been shown to be more accurate than radiographs in evaluating anterior interbody fusion but may still over-read the extent of fusion. PURPOSE: To assess the reliability and accuracy of fine-cut CT scans with reconstructions in evaluating anterior lumbar interbody fusion (ALIF) with metallic cages using surgical exploration as the reference standard. STUDY DESIGN: Accuracy of a diagnostic test referenced to the gold standard. PATIENT SAMPLE: A total of 49 patients and 69 surgical levels. OUTCOME MEASURES: Evaluation of fine-cut CT scans for evidence of fusion with subsequent surgical exploration as the reference standard. METHODS: Forty-nine patients who underwent ALIF with metallic cages over 69 levels, who had a fine-cut CT scan before revision were included. Five spine surgeons unaware of the findings on surgical exploration evaluated pre-revision CT scans, classified these as fused or not; and determined the presence of a "sentinel sign" and a "posterior sentinel sign." Kappa coefficients for interobserver reliability, sensitivity, and specificity to detect fusion were determined. RESULTS: There were 26 males and 23 females with a mean age of 43 years. There were 27 smokers. Average time from index to revision surgery was 22 months. Interobserver kappa for classification as fused or not was 0.25 with 70% to 97% sensitivity and 28% to 85% specificity. The interobserver kappa for the sentinel sign was 0.34 with 13% to 33% sensitivity and 77% to 92% specificity. The interobserver kappa for the posterior sentinel sign was 0.23 with 33% to 87% sensitivity and 56% to 90% specificity. CONCLUSIONS: Raters generally overstated fusion with low specificities across raters and low consensus specificity. Overall accuracy of the posterior sentinel sign (74%) was higher than the sentinel sign (61%). The low kappa value indicates fair reliability. In patients with metallic interbody devices, surgeons should be cautious about interpreting the findings on fine-cut CT scans whether using a general assessment of the fusion, the sentinel sign, or the posterior sentinel sign.


Subject(s)
Spinal Diseases/diagnostic imaging , Spinal Diseases/surgery , Spinal Fusion , Tomography, X-Ray Computed/standards , Adult , Aged , Diffusion Chambers, Culture , Female , Humans , Lumbar Vertebrae/diagnostic imaging , Lumbar Vertebrae/surgery , Male , Middle Aged , Observer Variation , Reference Standards , Reproducibility of Results , Sensitivity and Specificity , Tomography, X-Ray Computed/statistics & numerical data , Young Adult
13.
Spine J ; 8(6): 968-74, 2008.
Article in English | MEDLINE | ID: mdl-18201937

ABSTRACT

BACKGROUND CONTEXT: The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures: Oswestry Disability Index (ODI), the physical component summary (PCS) of the Short Form of the Medical Outcomes Study (SF-36), and pain scales. A minimum clinically important difference (MCID) is a threshold used to measure the effect of clinical treatments. Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method. PURPOSE: This study has three purposes. First, to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID. Second, to determine a statistically sound and clinically meaningful MCID for ODI, PCS, back pain scale, and leg pain scale in lumbar spine surgery patients. Third, to compare the discriminative ability of two anchors: a global health assessment and a rating of satisfaction with the results of the surgery. STUDY DESIGN: This study is a review of prospectively collected patient-reported outcomes data. PATIENT SAMPLE: A total of 454 patients from a large database of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study. OUTCOME MEASURES: Preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item (HTI) of the SF-36, and Satisfaction with Results scales. METHODS: ODI, SF-36, and pain scales were administered before and 1 year after spinal surgery. Several candidate MCID calculation methods were applied to the data and the resulting values were compared. The HTI of the SF-36 was used as the anchor and compared with a second anchor (Satisfaction with Results scale). RESULTS: Potential MCID calculations yielded a range of values: fivefold for ODI, PCS, and leg pain, 10-fold for back pain. Threshold values obtained with the two anchors were very similar. CONCLUSIONS: The minimum detectable change (MDC) appears as a statistically and clinically appropriate MCID value. MCID values in this sample were 12.8 points for ODI, 4.9 points for PCS, 1.2 points for back pain, and 1.6 points for leg pain.


Subject(s)
Back Pain/diagnosis , Back Pain/surgery , Disability Evaluation , Lumbar Vertebrae/surgery , Surveys and Questionnaires , Databases, Factual , Female , Follow-Up Studies , Humans , Leg , Male , Middle Aged , Pain Measurement , Patient Satisfaction , Treatment Outcome
14.
Spine J ; 7(5): 541-6, 2007.
Article in English | MEDLINE | ID: mdl-17448732

ABSTRACT

BACKGROUND CONTEXT: The effectiveness of spinal surgery as a treatment option is currently evaluated through the assessment of patient-reported outcomes (PROs). The minimum clinically important difference (MCID) represents the smallest improvement considered worthwhile by a patient. The concept of an MCID is offered as the new standard for determining effectiveness of a given treatment and describing patient satisfaction in reference to that treatment. PURPOSE: Our goal is to review the various definitions of MCID and the methods available to determine MCID. STUDY DESIGN: The primary means of determining the MCID for a specific treatment are divided into anchor-based and distribution-based methods. Each method is further subdivided and examined in detail. METHODS: The overall limitations of the MCID concept are first identified. The basic assumptions, statistical biases, and shortcomings of each method are examined in detail. RESULTS: Each method of determining the MCID has specific shortcomings. Three general limitations in the accurate determination of an MCID have been identified: the multiplicity of MCID determinations, the loss of the patient's perspective, and the relationship between pretreatment baseline and posttreatment change scores. CONCLUSIONS: An ideal means of determining the MCID for a given intervention is yet to be determined. It is possible to develop a useful method provided that the assumptions and methodology are initially declared. Our efforts toward the establishment of a MCID will rely on the establishment of specific external criteria based on the symptoms of the patient and treatment intervention being evaluated.


Subject(s)
Bias , Clinical Trials as Topic/methods , Data Interpretation, Statistical , Spinal Diseases/therapy , Humans , Sensitivity and Specificity , Treatment Outcome
15.
J Spinal Disord Tech ; 18(5): 396-401, 2005 Oct.
Article in English | MEDLINE | ID: mdl-16189449

ABSTRACT

OBJECTIVE: To determine whether preoperative disc space height (DSH) influences the clinical outcomes of patients diagnosed with single-level symptomatic discogenic disease and treated with a stand-alone anterior lumbar interbody fusion with two tapered threaded fusion cages, we performed a retrospective analysis of 392 patients. METHODS: Preoperative radiographs were used to establish four study groups based on the patients' DSH: the tall disc group: DSH >15 mm; the intermediate tall group: DSH ranging from 10 to 15 mm; the intermediate collapsed group: DSH ranging from 5 to 10 mm; and the collapsed disc group: DSH <5 mm. RESULTS: All of the patient groups exhibited improvement in their clinical outcomes. However, patients in the collapsed disc group (DSH of <5 mm) tended to have earlier and greater improvement in Oswestry Disability Index scores, Physical Component Summary scores of the Short Form-36, and Visual Analog Scale scores for low back pain. CONCLUSION: Symptomatic disc degeneration can be readily identified with plain radiographic findings, and patients' symptoms can often be relieved predictably with a stand-alone interbody fusion procedure.


Subject(s)
Intervertebral Disc/diagnostic imaging , Lumbar Vertebrae/surgery , Spinal Diseases/diagnostic imaging , Spinal Diseases/surgery , Spinal Fusion , Adult , Female , Humans , Intervertebral Disc/surgery , Low Back Pain/diagnostic imaging , Low Back Pain/etiology , Low Back Pain/surgery , Lumbar Vertebrae/diagnostic imaging , Male , Middle Aged , Pain Measurement , Radiography , Retrospective Studies , Spinal Diseases/complications , Treatment Outcome
16.
J Spinal Disord Tech ; 17(5): 372-9, 2004 Oct.
Article in English | MEDLINE | ID: mdl-15385876

ABSTRACT

OBJECTIVES: Obliteration of end-plate landmarks by interbody fusion has made the traditional measurement of segmental lumbar lordosis nearly impossible. Because the L4-L5 and L5-S1 levels are most likely to be subjected to fusion procedures or arthroplasty and contribute to more than half of normal lumbar lordosis, it is crucial to identify a reproducible and accurate means of measuring segmental lordosis at these levels. METHODS: Twelve spinal surgeons measured lordosis at L4-L5 and L5-S1 on 10 separate radiographs using three techniques for L4-L5 and four techniques for L5-S1. With use of identical radiographs, measurements first were made using a manual method and then were repeated with a computer-assisted method. Measurements were analyzed for both intraobserver and interobserver error. RESULTS: The individual data demonstrated an intraobserver variance of 9.56 and a standard deviation of 3.092 for computerized measurements compared with 7.742 and 2.782 for manual measurements. The interobserver variance was 4.107 with a standard deviation of 2.027 for the computerized group compared with 4.221 and 2.055 for manual measurements. When analyzed as a group to evaluate interobserver error, the pooled data yielded variance of 19.235 for the computerized group and 19.117 for the manual measurements. CONCLUSIONS: Variance calculations identified the Cobb technique and the posterior vertebral body technique as the least variable measurement techniques for the L4-L5 and L5-S1 levels, respectively; however, there was no statistical significance. In direct comparison, the manual and computer-assisted techniques were found to be statistically equivalent with similar degrees of variance. We believe that the anterior vertebral technique, which did not demonstrate a significant difference from other techniques, will prove to be the most reliable method of assessing segmental lumbar lordosis in patients before surgery, after interbody fusion, and after motion-sparing disc arthroplasty.


Subject(s)
Image Processing, Computer-Assisted/methods , Lordosis/diagnostic imaging , Lumbar Vertebrae/diagnostic imaging , Radiography/methods , Artifacts , Humans , Image Processing, Computer-Assisted/standards , Image Processing, Computer-Assisted/statistics & numerical data , Intervertebral Disc Displacement/surgery , Lordosis/pathology , Lordosis/surgery , Lumbar Vertebrae/pathology , Lumbar Vertebrae/surgery , Observer Variation , Predictive Value of Tests , Radiographic Image Interpretation, Computer-Assisted/methods , Radiography/standards , Radiography/statistics & numerical data , Reproducibility of Results , Sacrum/anatomy & histology , Sacrum/diagnostic imaging , Spinal Fusion/standards
17.
J Neurosurg ; 97(3 Suppl): 277-80, 2002 Oct.
Article in English | MEDLINE | ID: mdl-12408379

ABSTRACT

OBJECT: Pedicle screw fixation with transverse process fusion has gained widespread acceptance since its inception. Improved rates of arthrodesis have been demonstrated when this technique is used. The authors present one of the largest series of patients to undergo this procedure at a single center; one of the goals was to correlate construct length and spinal disease with rates of successful arthrodesis by conducting a prospective analysis of lumbar fusion in which pedicle screws were placed. METHODS: During a 7-year period, the senior author performed pedicle screw fixation with posterolateral fusion in 457 patients; the mean follow-up period was 28.4 months. Indications for fusion included metastatic tumor, single-level degenerative disc disease (DDD), trauma, degenerative scoliosis, and translational vertebral instability. Successful fusion was based on the radiographic demonstration of a bilateral contiguous osseous bridge over the transverse processes and absence of movement on dynamic x-ray films. Fusion rates were lowest in cases of tumors (54%) and highest in cases of trauma (96%). In patients with single-level DDD the rate was 91%, and in those with translational instability it was 89%. Fusion rates, however, declined steeply in relation to each additional motion segment in the translational instability group. In this group a strong linear trend for proportion was demonstrated (p < 0.001). The overall fusion rate in patients with degenerative scoliosis was 70%. The overall fusion rate for the entire group was 86%. CONCLUSIONS: The data in this study can be used as a benchmark with which to compare newer technologies. Although overall pedicle screw-assisted fusion rate in cases of trauma or selected degenerative lesions approached 90%, the arthrodesis rates are not uniform for the different diagnoses. This appears to be related to the underlying spinal disease and the number of segments included in the fusion.


Subject(s)
Bone Screws , Lumbar Vertebrae/surgery , Spinal Diseases/surgery , Spinal Fusion/methods , Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Prospective Studies , Spinal Fusion/adverse effects , Spinal Injuries/surgery
18.
J Neurosurg ; 97(4 Suppl): 468-72, 2002 Nov.
Article in English | MEDLINE | ID: mdl-12449203

ABSTRACT

Polyhydroxy acids are a promising class of resorbable materials with potential applications in spinal surgery. One such polymer, MacroPore (MacroPore Biosurgery, Inc.), offers a balance of strength, predictable degradation, lack of stimulus of foreign body reaction, and biocompatibility with neural tissue. MacroPore can be formed into an array of shapes and can be manufactured, sterilized, and stored using conventional techniques. Limited clinical experience has been gained with resorbable implants used as load-sharing devices in a posterior lumbar interbody fusion construct.


Subject(s)
Absorbable Implants , Hydroxy Acids/therapeutic use , Lumbar Vertebrae/drug effects , Lumbar Vertebrae/surgery , Spinal Diseases/drug therapy , Spinal Diseases/surgery , Spinal Fusion , Biocompatible Materials/therapeutic use , Humans , Lactic Acid/therapeutic use , Polyesters/therapeutic use , Polymers/therapeutic use
19.
Neurosurgery ; 51(5): 1191-8; discussion 1198, 2002 Nov.
Article in English | MEDLINE | ID: mdl-12383364

ABSTRACT

OBJECTIVE: With the proliferation of implant types available for use in posterior lumbar interbody fusion (PLIF) procedures, the choices for surgeons have become increasingly complex. The goal of this study was to retrospectively review a series of 49 patients who underwent PLIF with the use of allograft cylindrical threaded cortical bone dowels (TCBDs) and allograft impacted wedges. Nerve root injury rates, fusion rates, and clinical outcomes of the allograft impacted wedge group are compared with those in the allograft cylindrical TCBD group. METHODS: We performed a retrospective chart and radiographic review of 49 patients. Twenty-seven patients underwent PLIF with impacted allograft wedges, and 22 patients underwent PLIF with allograft cylindrical TCBD. Permanent nerve root injury rates, fusion rates, and clinical outcomes were assessed on the basis of a minimum of 1 year of follow-up data in this nonconsecutive series. RESULTS: Permanent nerve root injuries in the impacted wedge and TCBD groups were documented with physical examinations conducted pre- and postoperatively. The cylindrical TCBD group showed a 13.6% rate of permanent nerve root injury, and the impacted wedge group demonstrated a 0% rate, and these rates were statistically significant (analysis of variance, P = 0.049). The fusion rate at a mean of 13.9 months of follow-up was 95.4% in patients in whom the cylindrical TCBD was implanted and 88.9% after a mean of 17.4 months of follow-up in patients in whom impacted wedges were used. The fusion rate difference between the TCBD and impacted wedge groups was not significant. The satisfactory outcome rate was 72.7% for the TCBD group and 85.1% for the impacted wedge group, and the impacted wedge group was found to have a significantly higher rate of satisfactory outcomes (P = 0.016, analysis of variance). Analysis of the patient outcomes in the TCBD and impacted wedge groups according to sex, mean length of follow-up, workman's compensation claim rate, and smoking habit yielded no significant difference. CONCLUSION: With a minimum of 1 year of follow-up in this nonconsecutive series of 49 patients, a comparison of the use of allograft TCBD versus allograft impacted wedges in PLIF procedures reveals a statistically significant increase in permanent nerve root injury rates with the use of cylindrical TCBD implants as compared with impacted allograft wedges. There is no difference between the two groups in terms of fusion rates, and clinical outcomes with the use of impacted wedges were significantly better.


Subject(s)
Bone Transplantation/methods , Lumbar Vertebrae/surgery , Spinal Fusion/methods , Adolescent , Adult , Aged , Bone Transplantation/adverse effects , Female , Humans , Male , Middle Aged , Retrospective Studies , Spinal Fusion/adverse effects , Spinal Nerve Roots/injuries , Transplantation, Homologous , Treatment Outcome , Wounds and Injuries/etiology
20.
Orthopedics ; 25(10 Suppl): s1185-9; discussion s1189, 2002 Oct.
Article in English | MEDLINE | ID: mdl-12401030

ABSTRACT

Polyhydroxyacids are a promising class of bioresorbable materials withpotential applications in spinal surgery. One such polymer, MacroPore (MacroPore Biosurgery Inc, San Diego, Calif), offers a balance of strength, predictable degradation, lack of stimulus of foreign body reaction, and biocompatibility with neural tissue. MacroPore can be formed into an array of shapes and can be manufactured, sterilized, and stored with conventional techniques. Limited clinical experience has been gained with bioresorbable implants that are used as load-sharing devices in a posterior lumbar interbody fusion construct.


Subject(s)
Absorbable Implants , Intervertebral Disc Displacement/surgery , Lumbar Vertebrae/surgery , Polymers/pharmacology , Spinal Fusion/instrumentation , Biocompatible Materials , Biomechanical Phenomena , Compressive Strength , Female , Follow-Up Studies , Humans , Intervertebral Disc Displacement/diagnosis , Male , Prosthesis Design , Sensitivity and Specificity , Spinal Fusion/methods , Titanium/pharmacology , Treatment Outcome
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