A randomized prospective study of posterolateral lumbar fusion. Outcomes with and without pedicle screw instrumentation.

STUDY DESIGN: A prospective evaluation of the clinical and radiographic outcomes of 71 patients who underwent lumbar fusion, with or without transpedicular instrumentation. The patients completed a questionnaire that determined pain relief, medication use, return to work, and overall satisfaction with surgery. OBJECTIVES: To explore the effect, if any, of instrumentation on the outcome of lumbar fusion surgery, according to reports of the patients, and whether there is a correlation between the radiographic determination of a solid fusion and the same patient-reported outcome. SUMMARY OF BACKGROUND DATA: The literature on this topic reports pseudarthrosis rates from 0% to 57% and good to excellent results from 56% to 95%. These studies provide no clear-cut recommendations concerning the effect of added lumbar instrumentation on patient-reported outcome in a prospective manner using concurrent control subjects. METHODS: The patients were randomized to groups with and without instrumentation after deciding to undergo a lumbar fusion and consenting to enter the study. Radiographs were obtained and questionnaires filled out at 6 weeks, 6 months, 1 year, and 2 years after surgery. RESULTS: There was no statistical difference in patient-reported outcome between the two groups. There was a slight nonsignificant trend toward increased radiographic fusion rate in the group with instrumentation that did not correlate with an increased patient-reported improvement rate. CONCLUSIONS: These results do not provide data that indicate a benefit in outcome from added instrumentation in elective lumbar fusions.

Phase I safety and pharmacokinetic profile of an intercellular adhesion molecule-1 antisense oligodeoxynucleotide (ISIS 2302).

Healthy male volunteers received single or multiple intravenous infusions of an intercellular adhesion molecule-1 antisense phosphorothioate oligodeoxynucleotide, ISIS 2302, in a rising-dose (0.06-2.00 mg/kg infused over 2 hr), double-blind, placebo-controlled trial. Brief, dose-related increases in activated partial thromboplastin time were seen at the time of peak plasma concentration (C(max)). Clinically insignificant increases in C3a were seen after higher, repeated doses, but C5a, blood pressure and pulse were unaffected. No adverse events or other laboratory abnormalities were related to treatment with the drug. ISIS 2302 C(max) was linearly related to dose and occurred at the end of infusion. Plasma half-life for intact drug (53-54 min) and total oligonucleotide (67-74 min) were similar at the two doses (0.5 and 2.0 mg/kg) at which extensive pharmacokinetic data were collected. Nonlinear changes in area under the plasma concentration/time curve and steady-state volume of distribution with increasing dose suggested a saturable component to disposition. Metabolites co-migrating with n-1, n-2 and n-3 chain-shortened versions of ISIS 2302 appeared very rapidly in plasma, and disposition and metabolism appeared unaltered by repeated dosing. ISIS 2302 was well tolerated and behaved reproducibly with respect to plasma pharmacokinetics and expected side effects.

The ideal amount of lumbar foraminal distraction for pedicle screw instrumentation.

STUDY DESIGN: A cadaveric study was performed to analyze the changes of foraminal dimensions of the lumbar spine and also to estimate the amount of foraminal distraction, achieved with pedicle screw instrumentation, that will create the greatest improvement in foraminal dimensions. OBJECTIVES: To establish the ideal amount of lumbar foraminal distraction using pedicle screw instrumentation and to investigate the changes of adjacent segments and lumbar lordosis with distraction maneuvers. SUMMARY OF BACKGROUND DATA: In patients undergoing fusions and instrumentation for foraminal stenosis, distraction of the lumbar spine may improve the dimensions of the intervertebral foramen. Results of previous studies have shown that anterior interbody distraction of the lumbar spine significantly increased the space in the lumbar foramen. No previous study has assessed the ideal amount of distraction, changes in the adjacent segments, or the effect on lumbar lordosis using posterior pedicle screw instrumentation. METHODS: Six fresh frozen human cadaveric spines from 15 to the sacrum were used. The ISOLA instrumentation system (Acromed Inc., Cleveland, OH) was applied using pedicle screws at L4, L5, and S1, L4-L5 and L5-S1 rods were contoured to the same degree of lumbar lordosis as in the specimen. The spine was potted in the upright position with the sacrum secured in the mold, and an axial load of 40 pounds was applied to the specimen. Radiographs were used to measure the posterior disc height, foraminal height, foraminal area, and lumbar lordosis. Two mm, 4 mm, 6 mm, 8 mm, and 10 mm of single level distraction were added to L4-L5 and L5-S1. The dimensions of the specimen were digitized and calculated after each distraction. RESULTS: The posterior disc height, foraminal height and foraminal area increased with distraction. The greatest incremental change in the foraminal area was noted at 6 mm of distraction. The L4-L5 foraminal area increased 22.6% at 6 mm of L4-L5 distraction, and the L5-S1 foraminal area increased 39.2% at 6 mm of L5-S1 distraction. With distraction above 6 mm, the foraminal change plateaued. The greatest decrease in lumbar lordosis was only 4.6 degrees and occurred at 10 mm of distraction. There was no significant effect of distraction on the foramina of adjacent levels. CONCLUSION: Posterior distraction using pedicle screws increased foraminal dimensions. The ideal amount of distraction on the rod, or the minimal amount of distraction necessary for improving foraminal dimensions, may be 6 mm using pedicle screw instrumentation.

Traumatic spondylopelvic dissociation. A case report and literature review.

STUDY DESIGN: A case of traumatic spondylopelvic dissociation and a method of fixation are described. OBJECTIVES: The treatment of this rare injury pattern required differentiation from less severe lumbosacral fracture-dislocations or bilateral sacroiliac joint dislocations. SUMMARY OF BACKGROUND DATA: Several case reports have described less severe fracture patterns, but only a handful have illustrated true spondylopelvic dissociation in which there is complete displacement of the lumbar spine into the pelvis. METHODS: After initial stabilization at an outside hospital, the patient was transferred to the authors' institution for definitive care. After computed tomography imaging with three-dimensional multiplanar reconstruction, the fracture was stabilized with a pedicle screw construct attached to the pelvis by means of the Galveston technique. Bilateral iliosacral screws were used to increase stability. RESULTS: At a 2-year follow-up, the patient was pain-free and ambulating in an ankle-foot orthosis. He had a persistent deficit involving the right L5 and S1 nerve roots but was continent of stool. CONCLUSIONS: The unique fracture pattern described in this patient is presented to offer better insight into management of this complex injury and to delineate it from simpler patterns of injury to the lumbosacral junction.

Comparison between allograft plus demineralized bone matrix versus autograft in anterior cervical fusion. A prospective multicenter study.

STUDY DESIGN: This study analyzed the fusion results of an allograft-demineralized bone matrix composite versus autograft in a prospective series of patients undergoing surgery for cervical disc disease. OBJECTIVES: To determine the fusion rates of allograft-demineralized bone matrix composite in anterior cervical fusion as compared with the gold standard autograft. SUMMARY OF BACKGROUND DATA: For the anterior cervical fusion, the use of freeze-dried allograft is well documented in the literature, citing its effectiveness and inferior fusion rates. The use of demineralized bone matrix in conjunction with freeze-dried allograft in anterior cervical fusion has not been reported. METHODS: This study was done in a prospective fashion in two medical centers. One group received autograft from the anterior iliac crest, whereas others received freeze-dried allograft augmented with demineralized bone matrix (Grafton, Osteotech, Inc., Shrewsbury, New Jersey). For the autograft group, the standard Smith-Robinson grafting technique was used. For the allograft composite group, demineralized bone matrix was pasted onto the freeze-dried allograft and into the disc space before graft insertion. The autograft group consisted of 38 patients with age ranging 26-71 years (mean, 46.1 years) and follow-up periods of 12-33 months (mean, 18.4 months). There were 19 one-level, 17 two-level, and two three-level fusions. Similarly, the allograft group consisted of 39 patients with age ranging 28-80 years (mean, 48.0 years) with follow-up period of 12-31 months (mean, 17.5 months). There were 19 one-level, 16 two-level, and four three-level fusions. Clinical and radiographic follow-up evaluations were completed at 3-month intervals. Radiographs taken 12 months after surgery were analyzed blindly. RESULTS: Pseudarthrosis developed in 46.2% of patients (33.3% of levels) in the allograft-demineralized bone matrix group compared with 26.3% (22% of levels) in the autograft group (P = 0.11 for patients, P = 0.23 for levels). For patients undergoing two-level fusions, 37.5% of allograft-demineralized bone matrix failed compared with 23.5% of autografts. For single-level fusions, 47.4% of allograft patients developed a pseudarthrosis compared with 26.3% in the autograft group. Graft collapse of > or = 3 mm was noted in 11% of the autograft group versus 19% in the allograft-demineralized bone matrix group (P = 0.32). Graft collapse of > or = 2 mm occurred in 24.4% of autograft patients compared with 39.7% of the allograft-demineralized bone matrix group (P = 0.09). Smokers had an increased rate of pseudarthrosis (47.1%) compared with nonsmokers (27.9%, P = 0.13). CONCLUSIONS: The study revealed that the allograft-demineralized bone matrix construct gives a higher rate of graft collapse and pseudarthrosis when compared with autograft in a prospective series, although the differences were not statistically significant. The pseudarthrosis rate in the series may be high because of the large percentage of smokers and radiographic evaluation techniques. For the purpose of solid radiographic fusion, the use of autograft is recommended in anterior cervical surgery until other acceptable osteoinductive materials are developed.

The influence of anulotomy selection on disc competence. A radiographic, biomechanical, and histologic analysis.

STUDY DESIGN: This study analyzed the radiographic, biomechanical, and histologic attributes of three commonly used anulotomy techniques. OBJECTIVES: This study defined the propensity of the anulus fibrosus to heal after discectomy and correlated biomechanical differences between subgroups of the motion segments studied. SUMMARY OF BACKGROUND DATA: No previous report that compares the influence of anulotomy selection on disc competence exists. METHODS: Anulotomies were performed on the anterolateral aspects of the lumbar discs of 54 adult goats. The goats were randomly assigned to one of three subgroups containing 18 animals. In subgroup A, a full-thickness anular window was excised. In subgroup B, a full-thickness cruciate anulotomy was accomplished. In subgroup C, a full-thickness anulotomy was developed by inserting a trocar, 2.5 mm in diameter, into the disc. RESULTS: Histologic analysis revealed that primary anular healing did not occur in any specimen. The anulotomy tracts in subgroup C (trocar) were consistently narrower than those of subgroups A and B. Discography demonstrated the presence of severe and early disc degeneration with subgroup A (anular window), a finding not observed within the trocar anulotomy group. Biomechanical testing demonstrated increased resistance to pull out by the trocar anulotomy group at 4 weeks, as well as increased torsional stiffness of the motion segment when compared to both window and cruciate anulotomy. CONCLUSIONS: The authors conclude that attempts should be made to minimize injury to the anulus fibrosus during the performance of discectomy.

A survey of rationales for and against hand splinting in hemiplegia.

This study investigated rationales underlying splinting decisions involving patients with hemiplegia. The survey incorporated a limited-choice, multiple-option questionnaire based on the case study of a man with a left hemiparesis at three hypothetical stages of recovery. Ninety-three occupational therapists who answered indicated whether they would or would not recommend a splint at each stage, and selected one or more reasons for their decisions. The respondents fell into three major categories: those who would 1. never splint, 2. always splint, and 3. splint only in the presence of moderate to severe spasticity. Those with longer clinical experience reflected more tendency to splint. The results indicated conflicting practices in splinting and showed the need for further clinical research in this area.