A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results.

Patients suffering from neurogenic intermittent claudication secondary to lumbar spinal stenosis have historically been limited to a choice between a decompressive laminectomy with or without fusion or a regimen of non-operative therapies. The X STOP Interspinous Process Distraction System (St. Francis Medical Technologies, Concord, Calif.), a new interspinous implant for patients whose symptoms are exacerbated in extension and relieved in flexion, has been available in Europe since June 2002. This study reports the results from a prospective, randomized trial of the X STOP conducted at nine centers in the U.S. Two hundred patients were enrolled in the study and 191 were treated; 100 received the X STOP and 91 received non-operative therapy (NON OP) as a control. The Zurich Claudication Questionnaire (ZCQ) was the primary outcomes measurement. Validated for lumbar spinal stenosis patients, the ZCQ measures physical function, symptom severity, and patient satisfaction. Patients completed the ZCQ upon enrollment and at follow-up periods of 6 weeks, 6 months, and 1 year. Using the ZCQ criteria, at 6 weeks the success rate was 52% for X STOP patients and 10% for NON OP patients. At 6 months, the success rates were 52 and 9%, respectively, and at 1 year, 59 and 12%. The results of this prospective study indicate that the X STOP offers a significant improvement over non-operative therapies at 1 year with a success rate comparable to published reports for decompressive laminectomy, but with considerably lower morbidity.

Follow-up evaluation of resected lumbar vertebral chordoma over 11 years: a case report.

STUDY DESIGN: A case report with an 11-year follow-up assessment after resection and reconstruction for lumbar chordoma is given. The literature relevant to this topic is reviewed. OBJECTIVES: To report the long-term outcome in a case of lumbar chordoma, to review the literature on vertebral chordoma, and to outline the rationale for surgical resection in such cases. SUMMARY OF BACKGROUND DATA: Chordoma is a malignant bone tumor that grows slowly, often recurs locally, and metastasizes late. Although different treatment approaches exist, including radiation and surgery, the only curative treatment is early and complete surgical excision of the tumor. Immediate spinal stability must be achieved with appropriate replacement or bone graft with rigid fixation. METHODS: The 11-year follow-up evaluation of a 42-year-old woman with L3 and L4 vertebral body chordoma treated with complete removal, femoral shaft allograft replacement, fusion, and rigid metal fixation is reported. The patient was observed with serial physical examinations, radiographs, and laboratory studies over 11 years. RESULTS: At this writing, 11 years after the resection of the L3 and L4 chordoma, the patient is asymptomatic without evidence of recurrence or metastasis. CONCLUSIONS: As reported, vertebral chordomas are not curable, but the authors' experience contradicts this. The surgeon should aim at a wide, or at least a marginal, excision followed by a stable reconstruction.

Can the computerized physical examination differentiate normal subjects from abnormal subjects with benign mechanical low back pain?

Inconsistencies among physicians in the evaluation of benign low back conditions make standardization desirable. A computerized physical examination device was used to evaluate low back pain patients and compare their results with a normative database obtained from a selection of healthy subjects. A high-resolution motion analysis system tracked the movement of skin markers placed on the midline and pelvis. Surface electromyography electrodes placed above L(5) collected data from multifidus. From the kinematics of skin markers during flexion extension with lifts up to 32 kg, and lateral bending with lifts up to 4.6 kg, the following parameters were estimated: lumbosacral angle and elongation, contribution of each lumbar segment to the lordosis reduction, relative pelvic/spine motion and trunk velocity. First, the average normal value for each estimated parameter was determined using 40 normal subjects. For each subject, the difference between his parameter and the normal was processed by an expert system generating a normality index varying from zero (perfect abnormal) to one (perfect normal). To develop the expert system's rules, a preliminary group of 20 very abnormal subjects were used, such that the normality index separated them from the normals. For validation, a set of 29 WCB sprain patients and another set of 42 discogram positive were selected. Each subject was tested and his computerized normality index calculated without any clinicians' input. The computerized normality index was compared with the clinicians' evaluation which was taken to be the gold standard. The Receiver Operating Characteristic technique was used to quantify the discrepancies. Results show that the expert system can detect clinically abnormal subjects with accuracy (sensitivity 83-91% and specificity >/=90%) while providing quantitative information on workers' functional capacities.

Anatomic position of a herniated nucleus pulposus predicts the outcome of lumbar discectomy.

The purpose of this study was to determine whether the anatomic position of a lumbar disc herniation has any significant effect on the clinical outcome of lumbar discectomy. Between January 1988 and March 1993, 80 patients with simple disc herniations underwent lumbar discectomy for herniated nucleus pulposus. We reviewed preoperative computed tomography scans after discography and magnetic resonance imaging of the lumbar spine. Disc herniations were classified as central, paracentral, intraforaminal, extraforaminal, or multiregional broad-based protrusions. The Smiley-Webster evaluation scale, which divided patients into groups with excellent, good, fair, and poor clinical outcome and evaluated the long-term need for pain medication, was applied. The post-operative evaluation period ranged from 6 to 48 months. The clinical outcome was then correlated with the different positions of herniations. The frequencies of the clinical outcomes were compared using the chi 2 test. We found a poorer clinical outcome that was statistically significant in patients with central herniations and with multiregional protrusions. Most herniations occurred at the L4-L5 level (58.7%). However, the level of disc herniation was not found to be a predictor of clinical outcome. Form and anatomic position of the lumbar disc herniation are of prognostic value for the outcome of lumbar discectomy. Further studies are required to confirm our preliminary results and eventually help improve surgical indications for lumbar discectomy.

Instrumented laparoscopic spinal fusion. Preliminary Results.

STUDY DESIGN: Seventeen consecutive patients underwent laparoscopic instrumented interbody fusions using custom-designed delivery instrumentation and "BAK" fusion cages; both are manufactured by Spinetech and the former was developed by the authors. The cases were performed at two spine centers under Food and Drug Administration investigational device evaluation clinical trials. OBJECTIVES: We expect this approach will maintain a high fusion rate with diminished hospitalization time, recovery time, patient discomfort, and expense. The rehabilitative aspects of the procedure are a great improvement over traditional fusion approaches. SUMMARY AND BACKGROUND DATA: Extraordinary advances in many endoscopic surgical fields have resulted in many endoscopic surgical fields have resulted in lowered morbidity, expense, and suffering associated with their open surgery counterparts. The authors have developed prototype of delivery instruments for the current laparoscopic fusion cage delivery system. METHODS: The procedure is performed transperitoneally with carbon dioxide insufflation to enable video-assisted visualization through a 10-mm endoscope. Three 10-mm incisions and one 13- to 20-mm incision are required for one-level procedures. Two hollow titanium-threaded interbody implants are packed with autologous bone and inserted into the diseased interspace. RESULTS: Seventeen patients, with an average follow-up period of 8 months and a range of 6-12 months, underwent the procedure. There were 14 single-level fusions and three two-level fusions, all involving L4-S1 levels. There were two cases that required conversion to open procedures without sequelae; two patients had remote donor site wound infections eradicated with incision and drainage and antibiotics, and one patient required subsequent posterior spinal decompression because of a displaced endplate fracture. Average hospital stay was an average of 2 days, excluding two patients with complications and very prolonged stay. CONCLUSIONS: Although this procedure is associated with a long learning curve, the technique, once mastered, is effective and advantageous over current approaches to lumbar fusion. Operative time and hospital stay are expected to decrease with future instrumentation development and surgeon experience.

Successful management of female office workers with "repetitive stress injury" or "carpal tunnel syndrome" by a new treatment modality--application of low level laser.

Female office workers with desk jobs who are incapacitated by pain and tingling in the hands and fingers are often diagnosed by physicians as "repetitive stress injury" (RSI) or "carpal tunnel syndrome" (CTS). These patients usually have poor posture with their head and neck stooped forward and shoulders rounded; upon palpation, they have pain and tenderness at the spinous processes C5-T1 and the medial angle of the scapula. In 35 such patients we focused the treatment primarily at the posterior neck area and not the wrists and hands. A low level laser (100 mW) was used and directed at the tips of the spinous processes C5-T1. The laser rapidly alleviated the pain and tingling in the arms, hands and fingers, and diminished tenderness at the involved spinous processes. Thereby, it has become apparent that many patients labelled as having RSI or CTS have predominantly cervical radicular dysfunction resulting in pain to the upper extremities which can be managed by low level laser. Successful long-term management involves treating the soft tissue lesions in the neck combined with correcting the abnormal head, neck and shoulder posture by taping, cervical collars, and clavicle harnesses as well as improved work ergonomics.

Lumbar intraspinal synovial and ganglion cysts (facet cysts). Ten-year experience in evaluation and treatment.

STUDY DESIGN: This study analyzed the clinical history, physical examination, diagnostic studies, and operative and histologic findings in 19 patients with lumbar intraspinal synovial and ganglion facet cysts evaluated and treated over a 10-year period. OBJECTIVES: The results were correlated to provide a greater understanding of lumbar facet cysts and rationale for conservative or surgical treatments. SUMMARY OF BACKGROUND DATA: The 19 patients included 13 women and 6 men ranging in age from 38 to 79 years. 84.4% of the patients presented with radicular pain. 26.3% had significant motor deficit. 68.4% of the facet cysts were found at L4-L5, 21.1% at L5-S1, 5.2% at L1-L2, and 5.2% at L2-L3. METHODS: The clinical history and findings on physical examination, standard radiography, myelography, computed tomography-myelography, facet arthrography, post-facet arthrograph computed tomography, magnetic resonance imaging with and without contrast, and computed tomography scans were reviewed. RESULTS: Bilobed cysts were found on both dorsal and ventral aspects of the involved facet joints within and outside of the spinal canal on facet arthrography, computed tomography, magnetic resonance imaging, and at the time of surgery in more than 60% of the patients. Significant facet degeneration was found in 75% of standard radiographs, and on all of the magnetic resonance imaging and computed tomography scans. In six patients, symptoms improved with rest, medication, and bracing. Epidural corticosteroid injections provided short-term relief in three out of four patients. Facet corticosteroid injections provided good relief in one, partial relief in one, and no relief in one patient. Surgical decompression in eight patients resulted in three excellent, four good, and one fair outcome. CONCLUSIONS: Most of the lumbar intraspinal facet cysts were associated with significantly degenerated facet joints. Patients with intraspinal facet cysts may respond to conservative treatments if there is no significant neurologic deficit. Surgical decompression and removal of large facet cysts usually are successful in relieving symptoms.

Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease.

In review of 871 lumbar fusion procedures performed during the last 8 years, the theoretical advantages of lumbar spinal instrumentation are not borne out in simple discogenic disease. Four groups of 30-35 patients without previous surgery who underwent fusion by different techniques were matched for age, sex, length of follow-up, surgeons, number of levels fused, duration of preoperative symptoms, diagnosis, and type of third party payer. At least for the diagnoses of herniated disc with segmental instability and the instrumentation systems used in this study, results were superior with no internal fixation. This is in keeping with the higher complication rates and frequent need for implant removal reported by many authors.

Response to steroid and duration of radicular pain as predictors of surgical outcome.

Prolonged structural compromise of spinal nerve roots can lead to chronic changes that surgical decompression might not be able to reverse. In this study, it was hypothesized that if there were a reversible structural pain component, a steroid injected into the patient's symptomatic nerve root should provide temporary pain relief and that these patients should have a favorable surgical outcome. It also was hypothesized that duration of radicular symptoms would correlate inversely with surgical outcome. For postoperative relief of radicular pain, the results showed that patients with pain lasting less than 1 year had a positive surgical result (89%), regardless of response to steroid. Patients with pain lasting more than 1 year and who have had a positive response to steroid injected into the symptomatic nerve root (roots) had a positive surgical outcome of 85%. Patients who did not respond to the steroid and had pain for more than 1 year (95%) generally had a poor surgical outcome. Although the poor outcome in the last group might be explained in some cases by an inadequate structural correction, inadequate stabilization, or functional reasons, the majority of these failures represented irreversible changes in the neural structures.

Diptheroids and associated infections as a cause of failed instrument stabilization procedures in the lumbar spine.

Between February 1985 and October 1987, the authors identified seven patients with occult lumbar spine infections associated with the presence of spinal fixation hardware. Six of these infections were with organisms of low virulence; four of the seven patients had polymicrobial infections. All of the polymicrobial infections contained a Diptheroid as one of the isolates. Two of the seven patients studied had normal sedimentation rates. All had white blood cell counts less than 12,000 cells. Imaging studies were not helpful with the exception of one case with a positive gallium scan. The diagnoses were supported by clinical presentation, pathologic tissue changes, positive cultures, and response to therapy. Successful therapy was obtained by removal of hardware and treatment with antibiotics.

High lumbar disc degeneration. Incidence and etiology.

Three hundred seventy-nine consecutive magnetic resonance images (MRIs) with dual-echo images of the entire lumbar spine were reviewed by the authors. All 379 patients presented with back pain and/or leg pain; they were interviewed and examined. Pain drawings were completed by all. There were 42 patients (11.1%) with disc pathologies involving T12-L1, L1-2, and/or L2-3 levels. Six patients (1.6%) had isolated disc degeneration and/or herniations limited only to these high lumbar segments. The remaining 36 patients had degenerative changes of the higher discs with variable involvement of the lower lumbar discs. Out of 12 spondylolistheses of L5 on S1, 7 had high disc pathologies at one or more levels presenting as skipped lesions; more severe high disc lesions were noted in Grade II slips. Isolated high disc degeneration is often associated with pre-existing abnormalities such as end-plate defects, Scheuermann's disease, limbus vertebra, and so forth, and stressful cumulative work activities such as in construction workers, airplane mechanics, and so forth. High disc degeneration was noted above or below previous fractures. High disc involvement with diffuse changes in lower lumbar spine was more commonly found in ascending fashion in older age groups, and in patients who have had previous lower lumbar spine surgeries, prior fusions in particular. Our findings suggest that altered mechanics are associated with the high lumbar disc pathologies.

Metabolic bone disease in lumbar pseudarthrosis.

Pseudarthrosis occurs in many patients who undergo lumbar spine fusion and it has been suggested that abnormalities of bone metabolism contribute to it. The authors evaluated 47 patients with pseudarthrosis for metabolic bone disease. Symptomatic patients with pseudarthrosis underwent metabolic bone evaluation. Abnormal results of laboratory tests were found in 7 patients (14.9%): 3 low or borderline 1,25 dihydroxy vitamin D3, 2 elevated 24-hour urine calcium, and 2 low serum testosterone. None of these abnormalities correlated with other clinical findings. Bone density was low in 14 of 24 patients in whom it was measured. Low values did not correlate with smoking or abnormal laboratory values. Metabolic bone abnormalities do not appear to play a frequent or significant role in pseudarthrosis after attempted lumbar spine fusion.

Occult infections causing persistent low-back pain.

Occult infections caused by indolent organisms may produce persistent back pain that may be difficult to diagnose. The usual findings considered indicative of spinal infection are not reliable in these cases. The authors describe nine patients who presented with occult infections of the lumbar spine. Two of the nine had no antecedent lumbar surgeries nor open wounds. The predominant organisms were diptheroids and coagulase-negative staphylococci. The diagnosis was established by the clinical course, pathologic tissue changes at surgery, cultures, and response to antibiotic therapy. Normal Westergren sedimentation rates were noted in seven of nine patients, and normal white blood cell counts in six of nine patients. With the exception of two positive computed tomography (CT) scans, one positive gallium scan, and one positive magnetic resonance imaging (MRI) scan, all remaining imaging studies were negative for infection. In many cases, the infection neither was limited to nor involved the disc space.

Normal magnetic resonance imaging with abnormal discography.

In degenerative lumbar spine disease, recent studies have supported the clinical usefulness of discography, especially when used with computed tomography (CT) scanning. The role and capabilities of magnetic resonance imaging (MRI) scanning are currently evolving and being defined. This study reviews a series of patients with prolonged disabling symptoms who had normal MRI scans and abnormal discography. Discograms and discogram-CT scans may at times allow detection of clinically correlative and significant pathology (usually annular disruptions) not suggested by MRI scanning. This fact should be considered in patients with normal MRI scanning and continuing unexplained symptomatology.

Early results of spinal fusion using variable spine plating system.

Seventy-seven consecutive patients underwent application of variable spine plating (VSP) spinal plates between August 1984 and October 1985. Sixty-four percent had previous procedures at the same level or levels operated. Operative indications were spinal stenosis, segmental instability, unstable spondylolisthesis, herniated disc with instability, pseudoarthrosis, unstable fracture, and failed surgery syndrome with evidence of one of the preceding. Overall results showed 30% excellent, 30% good, 34% fair, 6% poor. There were four deep wound infections and 19 patients with one or more broken screws. Screw alignment and the angular relationship of each screw to the spinal plate are considered important technical factors in minimizing screw failure. Vigorous distraction of the vertebrae using interpedicular screws is rarely indicated. Twenty-four patients required reoperation. We feel the procedure is relatively indicated in cases of moderate to severe instability, such as some cases of spondylolisthesis, failed surgery with marked segmental instability, the obese, deconditioned patient, or cases of spinal stenosis rendered very unstable by surgical decompression, and most strongly indicated in unstable lumbar and thoracolumbar fractures.

Painful lumbar end-plate disruptions: a significant discographic finding.

Of the 692 discs injected during lumbar discograms, end-plate disruptions with leakage of contrast material into the vertebral bodies were noted in 14 discs. Although gentle pressure was applied during the injections, severe fully concordant pain was reproduced in four (28.3%) discs, moderately severe and fully concordant pain in nine (64.3%) discs, and mild discordant pain in one (7.4%) disc. This is compared to 11.2% of the remaining 678 discs without end-plate disruption that reproduced severe concordant pain, 31.1% with moderately severe concordant pain, 17.1% with mild pain, and 40.6% without any pain reproduction. The difference between pain frequency in discs with end-plate disruption and those without is statistically significant (P less than .001). This suggests that end-plate disruptions may be related to painful segments.

Lumbar laminectomy for herniated disc: a prospective controlled comparison with internal fixation fusion.

This is a controlled prospective study on a matched set of patients with herniated lumbar discs. Both groups received the same bilateral lumbar laminectomy and disc excision by the same surgeon. One group had the addition of an intertransverse fusion with internal fixation. Both groups were studied by an independent examiner at an average of 3 years postoperatively for success rate as determined by activity level, medication, subjective and objective evaluation. Both groups had similar age, sex, and occupational characteristics. No patient had prior surgical treatment or chemonucleolysis. Patients with associated lumbar spine problems such as stenosis, instability, or spondylolisthesis were excluded. Each patient had a positive clinical picture for a herniated lumbar disc, as well as a positive myelogram, venogram or computerized tomographic scan. Most had positive electromyograms. All patients received at least 3 months of conservative care. The 38 patients with fusion had a significantly longer mean time to return to work after surgery versus the 31 patients without fusion. Although the general success rate of both groups was 87%, the best results were in the nonfusion group. A total of 29% of nonfusions had excellent results whereas only 11% of the fusion group had excellent results. The conclusion is that fusions are not necessary and give less excellent results in simple laminectomy cases for herniated lumbar disc.

Lumbosacral fusions with Harrington rods and intersegmental wiring.

Harrington rods are a valuable adjunct for fusion of the lumbosacral spine. Major limits of distractions are achieved with these rods. Greater amounts of decompression are possible. Decompression, alignment, and stability are maintained. Intersegmental wiring increases security and eliminates the problem of hook and rod displacement and loss of lumbar lordosis. A variety of methods are available for sacral fixation to avoid neurologic complications from the distal hooks. Three- and four-level Harrington rod distraction lumbosacral fusions have proven to be successful in returning severely-disabled spinal stenotic, obese, and osteoporotic patients to normal activities.

Dwyer instrumentation in the treatment of adolescent idiopathic scoliosis.

Twenty-eight patients with adolescent idiopathic scoliosis treated by anterior spinal fusion with Dwyer instrumentation were reviewed. The average length of follow-up was 6.9 years. This technique produced better correction of lateral curvature and rotation than Harrington instrumentation, particularly in the thoracolumbar and lumbar region. The length of spine requiring fusion was also shorter. There is, however, a tendency for Dwyer instrumentation to lead to kyphosis. Morbidity was significant and included one case of paraplegia, four cases of deep infection and one case of instrument failure. All of these complications, except one case of deep infection, occurred in patients with curves with an apex above the seventh thoracic vertebra.

Rational use of operation in pericardial constriction.

The most appropriate operation for constricting pericardial disease must be selected to provide optimum chance for permanent recovery of myocardial function with minimal morbidity. Our 18 patients demonstrate the changing cause of pericardial constrictive disease and the application of newer surgical treatments. Good results were obtained in 16 patients.