Jeffrey S. Fischgrund

1997 volvo award winner in clinical studies: Degenerative lumbar spondylolisthesis with spinal stenosis : A prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation

Study Design. This prospective study analyzed the influence of transpedicular instrumented on the operative treatment of patients with degenerative spondylolisthesis and spinal stenosis. Objectives. To determine whether the addition of transpedicular instrumented improves the clinical outcome and fusion rate of patients undergoing posterolateral fusion after decompression for spinal stenosis with concomitant degenerative spondylolisthesis. Summary of Background Data. Decompression is often necessary in the treatment of symptomatic patients who have degenerative spondylolisthesis and spinal stenosis. Results of recent studies demonstrated that outcomes are significantly improved if posterolateral arthrodesis is performed at the listhesed level. A meta‐analysis of the literature concluded that adjunctive spinal instrumentation for this procedure can enhance the fusion rate, although the effect on clinical outcome remains uncertain. Methods. Seventy‐six patients who had symptomatic spinal stenosis associated with degenerative lumbar spondylolisthesis were prospectively studied. All patients underwent posterior decompression with concomitant posterolateral intertransverse process arthrodesis. The patients were randomized to a segmental transpedicular instrumented or noninstrumented group. Results. Sixty‐seven patients were available for a 2‐year follow‐up. Clinical outcome was excellent or good in 76% of the patients in whom instrumentation was placed and in 85% of those in whom no instrumentation was placed (P = 0.45). Successful arthrodesis occurred in 82% of the instrumented cases versus 45% of the noninstrumented cases (P = 0.0015). Overall, successful fusion did not influence patient outcome (P = 0.435). Conclusions. In patients undergoing single‐level posterolateral fusion for degenerative spondylolisthesis with spinal stenosis, the use of pedicle screws may lead to a higher fusion rate, but clinical outcome shows no improvement in pain in the back and lower limbs

Surgical Versus Nonoperative Treatment for Lumbar Disc Herniation Four-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

Study Design. Concurrent, prospective, randomized, and observational cohort study. Objective. To assess the 4-year outcomes of surgery versus nonoperative care. Summary of Background Data. Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to nonoperative treatment remain controversial. Methods. Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective, randomized (501 participants), and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual nonoperative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 months, 6 months, and annually thereafter. Results. Nonadherence to treatment assignment caused the intent-to-treat analyses to underestimate the treatment effects. In the 4-year combined as-treated analysis, those receiving surgery demonstrated significantly greater improvement in all the primary outcome measures (mean change surgery vs. nonoperative; treatment effect; 95% CI): BP (45.6 vs. 30.7; 15.0; 11.8 to 18.1), PF (44.6 vs. 29.7; 14.9;12.0 to 17.8) and ODI (−38.1 vs. −24.9; −13.2; −15.6 to −10.9). The percent working was similar between the surgery and nonoperative groups, 84.4% versus 78.4% respectively. Conclusion. In a combined as-treated analysis at 4 years, patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperatively treated patients in all primary and secondary outcomes except work status.

Complication, survival rates, and risk factors of surgery for metastatic disease of the spine.

STUDY DESIGN The risk factors for complications and complication and survival rates in patients with metastatic disease of the spine were reviewed. A retrospective study was performed. OBJECTIVES To determine the surgical complication and survival rates of patients with metastatic disease of the spine and risk factors for complication occurrence. SUMMARY OF BACKGROUND DATA The role of surgical intervention for patients with metastatic disease of the spine has been controversial. Several risk factors for surgical complications have been identified. Short survival times and high complication rates have failed to justify surgical intervention in many cases. METHODS Patients (n = 80) undergoing surgical treatment for metastatic disease of the spine were reviewed. Surgical indications included progressive neurologic deficit, neurologic deficit failing to respond to, or progressing after, radiation treatment; intractable pain; radioresistant tumors; or the need for histologic diagnosis. Patients underwent anterior, posterior, or combined decompression and stabilization procedures. Neurologic examination was recorded before surgery, postoperative period, and at least follow-up. Complication and survival rates were calculated. Several variables were examined for risk of complication. RESULTS The mean age at time of surgery was 55.6 years (range, 20-84 years). Mean survival time after the diagnosis of spinal metastasis was 26.0 months (range, 1-107.25 months). Mean survival time after surgery was 15.9 months (range, 0.25-55.5 months). Sixty-five patients showed no change in Frankel grade, 19 improved one Frankel grade, and 1 deteriorated one Frankel grade; 1 patient had paraplegia. Thirty-five complications occurred in 20 patients (25.0%). Ten patients (12.5%) had multiple complications accounting for 23 of the 35 postoperative problems (65.7%). Sixty patients had no surgical complications (75%). There were no intraoperative deaths. CONCLUSIONS The likelihood that a complication occurred was significantly related to Harrington classifications demonstrating significant neurologic deficits and the use of preoperative radiation therapy. In general, Harrington classifications with neurologic deficits and lower Frankel grades before and after surgery were associated with an increased risk of complication. Overall, the major complication rate was relatively low, and minor complications were successfully treated with minimal morbidity. The relatively long survival time after spinal surgery in this group of patients justifies surgical treatment for metastatic disease. Most complications occurred in a small percentage of patients. To minimize complications, patients must be carefully selected based on expected length of survival, the use of radiation therapy, presence of neurologic deficit, and impending spinal instability or collapse caused by bone destruction.

Bone grafting alternatives in spinal surgery

BACKGROUND CONTEXT Bone grafting is used to augment bone healing and provide stability after spinal surgery. Autologous bone graft is limited in quantity and unfortunately associated with increased surgical time and donor-site morbidity. Alternatives to bone grafting in spinal surgery include the use of allografts, osteoinductive growth factors such as bone morphogenetic proteins and various synthetic osteoconductive carriers. PURPOSE Recent research has provided insight into methods that may modulate the bone healing process at the cellular level in addition to reversing the effects of symptomatic disc degeneration, which is a potentially disabling condition, managed frequently with various fusion procedures. With many adjuncts and alternatives available for use in spinal surgery, a concise review of the current bone grafting alternatives in spinal surgery is necessary. STUDY DESIGN/SETTING A systematic review of the contemporary English literature on bone grafting in spinal surgery, including abstract information presented at national meetings. METHODS Bone grafting alternatives were reviewed as to their efficacy in extending or replacing autologous bone graft sources in spinal applications. RESULTS Alternatives to autologous bone graft include allograft bone, demineralized bone matrix, recombinant growth factors and synthetic implants. Each of these alternatives could possibly be combined with autologous bone marrow or various growth factors. Although none of the presently available substitutes provides all three of the fundamental properties of autograft bone (osteogenicity, osteoconductivity and osteoinductivity), there are a number of situations in which they have proven clinically useful. CONCLUSIONS Alternatives to autogenous bone grafting find their greatest appeal when autograft bone is limited in supply or when acceptable rates of fusion may be achieved with these substitutes (or extenders) despite the absence of one or more of the properties of autologous bone graft. In these clinical situations, the morbidity of autograft harvest is reasonably avoided. Future research may discover that combinations of materials may cumulatively result in the expression of osteogenesis, osteoinductivity and osteoconductivity found in autogenous sources.

Computed tomography-guided biopsy of the spine : A review of 103 patients

Study Design. A retrospective study of 103 computed tomography‐guided biopsies of the spine. These represent a consecutive series of patients with spinal lesions or disorders observed over a 32‐month period. Objectives. To determine the diagnostic accuracy and clinical usefulness of computed tomography‐guided biopsies with respect to major influencing variables. Summary of Background Data. Computer tomographic‐guided biopsy of the spine is considered a safe, accurate, and relatively inexpensive examination technique. A study comparing its diagnostic accuracy with respect to all the variables of age, gender, radiographic appearance, spinal level, tissue type, or pathologic diagnosis has not been done. Methods. Biopsy specimens were sent for cytologic and histologic analysis. Bacteriologic studies were performed when clinically indicated. The biopsy results were analyzed for adequacy and diagnostic accuracy, i.e., the ability to generate a tissue sample adequate for pathologic examination and one that yields diagnostic information. Results. The mean age of patients was 60 years, with a range of 4‐91 years. The spines of 52 males and 51 females were studied. There were eight cervical, 28 thoracic, 53 lumbar, and 14 sacral lesions used as biopsy sites. The radiographic appearance of spinal lesions were lytic in 74 cases, blastic in four cases, and mixed in two cases. Tissues undergoing biopsy included bone (63 cases), soft tissue (35 cases), and mixed specimens (five cases). The pathologic examinations revealed 18 infections, 23 primary neoplasms, 34 metastases, and 19 normal tissues. An adequate specimen for pathologic examination was obtained in 90 biopsies (87%). A diagnosis was achieved in 67 of 94 patients (71%). Diagnostic rates obtained in thoracic level biopsies were lower than those from biopsies of other spinal levels (P = .007). Conclusion. Computed tomography‐guided biopsy is an important tool in the evaluation of spinal lesions. A positive biopsy result may preclude the need for open surgical intervention. This study included one of the largest series of patients in the medical literature. In addition, it determined the diagnostic rates of this procedure with respect to the major influencing variables. Thoracic‐level biopsies have a diagnostic rate that is significantly lower than that of other spinal levels. No significant correlation was found between diagnostic accuracy and age, gender, radiographic appearance, tissue type, or eventual diagnosis.

Efficacy of closed wound suction drainage after single-level lumbar laminectomy

The use of closed suction drainage after spinal surgery remains controversial. The purpose of this study was to determine the indications for closed suction drainage after single-level lumbar surgery. Two hundred patients who were scheduled to undergo single-level lumbar surgery without fusion were prospectively randomized into two groups. One group had a closed wound suction drain placed deep to the lumbodorsal fascia before routine closure, whereas the second group had no drain placed. Hemostasis was achieved in all patients before the surgeon had knowledge of the randomization outcome. All drains were removed on the 2nd postoperative day, and the amount of drainage was recorded. After surgery, the patients were evaluated for signs and symptoms of continued wound drainage, hematoma/seroma formation, and/or infection as well as evidence of an acquired neurologic deficit. One hundred three patients had a drain placed before closure and two patients developed postoperative wound infection, both of which were successfully treated with orally administered antibiotics. Of the 97 patients who had no drain placed after the surgical procedure, one patient developed a postoperative wound infection that was treated with surgical incision and drainage, as well as intravenously administered antibiotics. Statistical analysis revealed that the presence or absence of a drain did not affect the postoperative infection rate. No new neurologic deficits occurred in any postoperative patient. The use of drains in single-level lumbar laminectomy without fusion did not affect patient outcome. There was no significant difference in the rate of infection or wound healing and no patient developed a postoperative neurologic deficit.

The effect of interposition membrane on the outcome of lumbar laminectomy and discectomy

Study Design. This study evaluated clinical and magnetic resonance imaging differences of patients treated surgically for lumbar disc herniation. Clinical follow-up and magnetic resonance imaging evaluation of epidural fibrosis were used to assess patient outcome. Objectives. The purpose of this study was to evaluate the difference in clinical outcome with either free-fat graft, Golfoam, or no interposition membrane placed in the laminectomy defect after nerve root decompression. Summary of Background Data. Epidural fibrosis has been considered a cause of recurrent symptoms after lumbar laminectomy, and numerous materials have been evaluated for prophylaxis of the “laminectomy membrane.” These have been mainly histologic and animal studies with no data correlating clinical symptoms and postoperative epidural scar formation. Methods. One hundred fifty-six patients who were treated surgically for lumbar disc herniation were randomly assigned to one of three groups and followed prospectively for at least 1 year. Thirty-three of these patients were received magnetic resonance imaging evaluations after 6 months by an idependent radiologist who graded the amount of epidural scar formation. The patients were assessed at 1 year and given a rating of excellent, good, fair, or poor, and the scar was graded as none, minimal, or moderate. Results. Although 97% of all patients improved, 83% were rated excellent or good. There were no statistical differences between the three groups clinically and radiographically. Patients with workers compensation had a statistically significant lower success rate (P <0.001). Conclusions. Clinical outcome after lumbar disc surgery does not correlate with the use or type of interposition membrane used to prevent epidural fibrosis.

The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis: a long-term (>4 years) pivotal study.

Study Design. Randomized controlled trial comparing OP-1 (rhBMP-7) with iliac crest autograft in patients with symptomatic degenerative spondylolisthesis and spinal stenosis treated with decompression and uninstrumented posterolateral arthrodesis. Objective. To determine the safety and the clinical and radiographic efficacy of OP-1 (rhBMP-7) Putty as compared with an iliac crest bone autograft control in uninstrumented, single-level posterolateral spinal arthrodesis. Summary of Background Data. Preclinical and preliminary clinical data have demonstrated successful fusion and clinical outcomes with the use of OP-1 Putty in posterolateral spinal arthrodesis. No prior randomized controlled trial with adequate study power has been performed. Methods. A total of 335 patients were randomized in 2:1 fashion to receive either OP-1 Putty or autograft in the setting of an uninstrumented posterolateral arthrodesis performed for degenerative spondylolisthesis and symptomatic spinal stenosis. Patients were observed serially with radiographs, clinical examinations, and appropriate clinical indicators, including ODI, Short-Form 36, and visual analog scale scores. Serum samples were examined at regular intervals to assess the presence of antibodies to OP-1. The primary end point, Overall Success, was analyzed at 24 months. The study was extended to include additional imaging data and long-term clinical follow-up at 36+ months. At the 36+ month time point, CT scans were obtained in addition to plain radiographs to evaluate the presence and location of new bone formation. Modified Overall Success, including improvements in ODI, absence of retreatment, neurologic success, absence of device-related serious adverse events, angulation and translation success, and new bone formation by CT scan (at 36+ months), was then calculated using the 24-month primary clinical endpoints, updated retreatment data, and CT imaging and radiographic end points. Results. OP-1 Putty was demonstrated to be statistically equivalent to autograft with respect to the primary end point of modified overall success. The use of OP-1 Putty when compared to autograft was associated with statistically lower intraoperative blood loss and shorter operative times. Although patients in the OP-1 Putty group demonstrated an early propensity for formation of anti-OP-1 antibodies, this resolved completely in all patients with no clinical sequelae. Conclusion. OP-1 Putty is a safe and effective alternative to autograft in the setting of uninstrumented posterolateral spinal arthrodesis performed for degenerative spondylolisthesis and symptomatic spinal stenosis.

The argument for instrumented decompressive posterolateral fusion for patients with degenerative spondylolisthesis and spinal stenosis.

The role of arthrodesis in the operative management of lumbar spinal stenosis with associated degenerative spondylolisthesis has been the subject of numerous reports over the past several decades. Although in the minority, some surgeons have reported clinical success after decompression alone, whereas the majority of authors recommend concomitant posterolateral fusion for the patient who requires decompression for spinal stenosis with associated degenerative spondylolisthesis. In 1991, Herkowitz and Kurz published a randomized prospective study comparing the results of decompressive lumbar laminectomy alone, with lumbar laminectomy and posterolateral arthrodesis. Fifty patients were assigned alternatively to the 2 groups and were evaluated at a mean of 3 years after the surgical procedure. The results of this landmark study indicated that those patients who had an arthrodesis at the time of the initial surgical outcome had a statistically significant improvement in their clinical outcome. The meta-analysis by Mardjetko et al concerning the operative treatment of degenerative spondylolisthesis also demonstrated that the outcome was significantly better when concomitant arthrodesis was performed (P 0.0001). According to his analysis, the clinical result was satisfactory in only 69% of the 260 patients who had a decompression without spinal arthrodesis, with progression of the spondylolisthesis in 31% of these patients. Those patients who had an operative decompression with posterolateral arthrodesis realized a satisfactory clinical outcome of 90%, with a progressive listhesis in only 17%. These two studies, as well as many others, have conclusively shown that patients undergoing decompression for spinal stenosis and degenerative spondylolisthesis have an improved clinical outcome with the addition of an arthrodesis attempt. However, many questions arose regarding those patients who had an attempt arthrodesis, but went on to a pseudarthrosis. Herkowitz and Kurz initially felt that even the attempt at arthrodesis was beneficial, in that it decreased subsequent motion, thereby leading to a satisfactory long-term outcome. However, as their initial study was concluding in the early 1990s, the use of spinal instrumentation was becoming more common for many surgical lumbar procedures. Therefore, the question was raised regarding the outcome of this group of patients if instrumentation was performed at the same time of arthrodesis. Would this improve the fusion rate? More importantly, would this improve the clinical outcome? Finally, what will happen to these patients long-term? Although short-term results look promising, where will these patients be in 5, 10, or 15 years? These questions led to a second prospective randomized study performed at our institution in the mid 1990s. In 1997, my colleagues and I published a prospective randomized study comparing the results of decompression and arthrodesis alone with those of decompression and arthrodesis combined with instrumentation. Sixtyeight patients were randomized to one of these two treatment groups. After an average of 2 years of follow-up, the results demonstrated that the addition of spinal instrumentation improved the fusion rate (83% vs. 45%). However, during this short-term follow-up, no significant difference in clinical outcome was noted. An obvious criticism of this paper is the relatively short-term follow-up, as well as the fact that we reported a very low fusion rate in the noninstrumented patients. Although the use of instrumentation did not show a change in clinical outcome at 2 years, the question remained: what happened to these patients long-term? In an effort to answer these questions, we undertook Part III of our study, which involved 47 of the patients from the prior two studies with single-level symptomatic spinal stenosis and spondylolisthesis. We selected those patients treated with posterior decompression and bilateral posterior arthrodesis with autogenous bone graft and no instrumentation. These patients were observed from 5 to 14 years, with an average follow-up of 8 years. We found that long-term clinical outcome was excellent or good in 86% of patients with solid arthrodesis, but only 56% of patients who developed a pseudarthrosis (P 0.01). Significant differences in residual back and lower limb pain was discovered between the two groups, with the solid fusion group performing significantly better in the symptom, severity, and physical function categories on selfadministered questionnaires. We concluded that those patients undergoing single-level decompression with posterior arthrodesis for spinal stenosis and concurrent spondylolisthesis, who had a solid fusion, had improved clinical results. In this study, we demonstrated the benefit From Weissman, Gitlin, Herkowitz, M.D., P.C., Southfield, Missouri. The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication. No funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript. Address correspondence to Jeffrey S. Fischgrund, MD, 27207 Lahser Road, Suite 200-B, Southfield, MI 48076, USA; E-mail : jsfischgrund@comcast.net

Contemporary management of isthmic spondylolisthesis: pediatric and adult

BACKGROUND Isthmic spondylolisthesis is common in pediatric and adult patients. Most cases are asymptomatic. When symptomatic, nonsurgical treatment is an appropriate first step. Surgical treatment of this condition varies depending on patient age, degree of slip, presence of neurologic findings, and degree of deformity. PURPOSE To review the literature on the management of isthmic spondylolisthesis in pediatric and adult patients. STUDY DESIGN Review article. METHODS Literature review. RESULTS AND CONCLUSIONS Achieving a solid fusion leads to improved functional outcomes and reduction in pain. A circumferential fusion is associated with a higher fusion rate and has become more common, especially with high-grade slips. The need for reduction is controversial and is mostly indicated for patients with significant lumbosacral kyphosis and sagittal imbalance.