Harry N. Herkowitz

Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis.

Fifty patients who had spinal stenosis associated with degenerative lumbar spondylolisthesis were prospectively studied clinically and radiographically to determine if concomitant intertransverse-process arthrodesis provided better results than decompressive laminectomy alone. There were thirty-six women and fourteen men. The mean age of the twenty-five patients who had had an arthrodesis was 63.5 years and that of the twenty-five patients who had not had an arthrodesis, sixty-five years. The level of the operation was between the fourth and fifth lumbar vertebrae in forty-one patients and between the third and fourth lumbar vertebrae in nine patients. The patients were followed for a mean of three years (range, 2.4 to four years). In the patients who had had a concomitant arthrodesis, the results were significantly better with respect to relief of pain in the back and lower limbs.

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 nonsurgical therapy for lumbar spinal stenosis.

BACKGROUND Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials. METHODS Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S. spine clinics. Treatment was decompressive surgery or usual nonsurgical care. The primary outcomes were measures of bodily pain and physical function on the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36) and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and 1 and 2 years. RESULTS A total of 289 patients were enrolled in the randomized cohort, and 365 patients were enrolled in the observational cohort. At 2 years, 67% of patients who were randomly assigned to surgery had undergone surgery, whereas 43% of those who were randomly assigned to receive nonsurgical care had also undergone surgery. Despite the high level of nonadherence, the intention-to-treat analysis of the randomized cohort showed a significant treatment effect favoring surgery on the SF-36 scale for bodily pain, with a mean difference in change from baseline of 7.8 (95% confidence interval, 1.5 to 14.1); however, there was no significant difference in scores on physical function or on the Oswestry Disability Index. The as-treated analysis, which combined both cohorts and was adjusted for potential confounders, showed a significant advantage for surgery by 3 months for all primary outcomes; these changes remained significant at 2 years. CONCLUSIONS In the combined as-treated analysis, patients who underwent surgery showed significantly more improvement in all primary outcomes than did patients who were treated nonsurgically. (ClinicalTrials.gov number, NCT00000411 [ClinicalTrials.gov].).

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.

Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease.

Study Design. A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. Objective. To evaluate the safety and effectiveness of the ProDisc®-L (Synthes Spine, West Chester, PA) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1. Summary of Background Data. As part of the Investigational Device Exemption clinical trial, favorable single center results of lumbar total disc replacement with the ProDisc®-L have been reported previously. Methods. Two hundred eighty-six (286) patients were treated on protocol. Patients were evaluated before and after surgery, at 6 weeks, 3, 6, 12, 18, and 24 months. Evaluation at each visit included patient self-assessments, physical and neurologic examinations, and radiographic evaluation. Results. Safety of ProDisc®-L implantation was demonstrated with 0% major complications. At 24 months, 91.8% of investigational and 84.5% of control patients reported improvement in the Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index [ODI]) from preoperative levels, and 77.2% of investigational and 64.8% of control patients met the ≥15% Oswestry Disability Index improvement criteria. Overall neurologic success in the investigational group was superior to the control group (91.2% investigational and 81.4% control; P = 0.0341). At 6 weeks and 3 months follow-up time points, the ProDisc®-L patients recorded SF-36 Health Survey scores significantly higher than the control group (P = 0.018, P = 0.0036, respectively). The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment (P < 0.0001). Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group (P = 0.015). Radiographic range of motion was maintained within a normal functional range in 93.7% of investigational patients and averaged 7.7°. Conclusions. ProDisc®-L has been found to be safe and efficacious. In properly chosen patients, ProDisc®-L has been shown to be superior to circumferential fusion by multiple clinical criteria.

Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial.

Study Design. Randomized trial and concurrent observational cohort study. Objective. To compare 4 year outcomes of surgery to nonoperative care for spinal stenosis. Summary of Background Data. Surgery for spinal stenosis has been shown to be more effective compared to nonoperative treatment over 2 years, but longer-term data have not been analyzed. Methods. Surgical candidates from 13 centers in 11 US states with at least 12 weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort (RC) or observational cohort (OC). Treatment was standard decompressive laminectomy or standard nonoperative care. Primary outcomes were SF-36 bodily pain (BP) and physical function scales and the modified Oswestry Disability index assessed at 6 weeks, 3 months, 6 months, and yearly up to 4 years. Results. A total of 289 patients enrolled in the RC and 365 patients enrolled in the OC. An as-treated analysis combining the RC and OC and adjusting for potential confounders found that the clinically significant advantages for surgery previously reported were maintained through 4 years, with treatment effects (defined as mean change in surgery group minus mean change in nonoperative group) for bodily pain 12.6 (95% confidence interval [CI], 8.5–16.7); physical function 8.6 (95% CI, 4.6–12.6); and Oswestry Disability index −9.4 (95% CI, −12.6 to −6.2). Early advantages for surgical treatment for secondary measures such as bothersomeness, satisfaction with symptoms, and self-rated progress were also maintained. Conclusion. Patients with symptomatic spinal stenosis treated surgically compared to those treated nonoperatively maintain substantially greater improvement in pain and function through 4 years.

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.

A comparison of anterior cervical fusion, cervical laminectomy, and cervical laminoplasty for the surgical management of multiple level spondylotic radiculopathy.

The risks and success of surgery for multiple level cervical spondylotic radiculopathy differs from that of single level disease. The problems associated with multiple level anterior fusion over single level fusion include higher pseudoarthrosis rates than that associated with single level disease. Bilateral and multiple level laminectomy carries the risk of potential instability. Cervical laminoplasty, until recently, has only been peformed for myelopathy secondary to ossification of the posterior longitudinal ligament (OPLL) or cervical stenosis. The purpose of this report is to compare the results and complications of 45 patients with a least a 2-year follow-up who had undergone anterior fusion, cervical laminectomy, or cervical laminoplasty for the surgical management of multiple level cervical radiculopathy due to cervical spondylosis. 18 patients (58 levels) underwent anterior fusion, 12 patients (38 levels) had a cervical laminectomy, and 15 patients (57 levels) underwent a cervical laminoplasty. Roentgenograms indicated spinal stenosis (sagittal diameter less than 12 mm) at 28 levels (15 patients) for the anterior fusion group, 14 levels (9 patients) in the laminectomy group, and 24 levels (13 patients) in the laminoplasty group. Subluxation (2 mm or less) was present at 14 levels (13 patients) in the anterior fusion group, nine levels (9 patients) in the laminectomy group, and 15 levels (8 patients) in the laminoplasty group. Loss of lordosis was present in eight patients undergoing anterior fusion, six patients undergoing laminectomy, and six patients who had a laminoplasty. The success rate was 92% (excellent-4, good-13, poor-1) for anterior fusion, 66% (excellent-2, good-6, poor-4) for cervical laminectomy and 86% (excellent-5, good-8, poor-2) for cervical laminoplasty. When the success rate was evaluated for unilateral vs. bilateral radiculopathy, anterior fusion provided the best results. (9/9 unilateral, 8/9 bilateral) followed by laminoplasty (6/6 unilateral, 7/9 bilateral). Laminectomy gave the poorest result for bilateral radiculopathy 3/5 poor vs. 6/7 good for unilateral radiculopathy. The results permit the following conclusions: 1) Anterior cervical fusion provides the best results for surgical treatment of multi-level cervical radiculopathy secondary to spondylosis. 2) Cervical laminoplasty provides an effective alternative to anterior fusion. 3) Cervical laminectomy provided the least favorable results for the surgical treatment of multi-level spondylosis. 4) Range of motion is most limited by cervical laminoplasty.

Surgical Management of Cervical Soft Disc Herniation: A Comparison Between the Anterior and Posterior Approach

Anterior cervical fusion was initially described in the 1950s for cervical spondylotic radiculopathy. The indications for this procedure in the management of soft disc herniation have not been clearly defined. In addition, controversy exists as to whether a cervical soft herniation should be managed by an anterior approach or a posterior cervical laminotomy-foraminotomy. The authors report the results of a prospective study comparing anterior discectomy and fusion to posterior laminotomy-foraminotomy for the management of soft cervical disc herniation. Twenty-eight patients underwent anterior discectomy and fusion (Robinson horseshoe graft) while 16 patients underwent posterior laminotomy-foraminotomy. The disc herniations were classified into two types. Type I were single level anterolateral herniations (33 patients) while type II were central soft disc herniations (11 patients). Clinically, patients with type I herniations manifested signs and symptoms of radiculopathy while patients with type II herniations manifested signs of myelopathy or neck pain and bilateral upper extremity paresthesias in 4 patients. Confirmatory studies were myelography in 12 patients, myelography combined with computed tomography (CT) in 26 patients, and magnetic resonance imaging (MRI) in 6 patients. For type I herniations, 17 patients underwent anterior fusion while 16 patients had a posterior laminotomy-foraminotomy. The 11 patients classified as type II herniation all underwent anterior discectomy and fusion. There were 27 men and 17 women. The age range was 21 to 52 years (mean, 41 years). The follow-up was 1.6 to 8.2 years (mean, 4.2 years). The results were graded as excellent (complete relief of pain and weakness), good (improvement of pain and weakness requiring occasional analgesics without lifestyle restrictions), fair (improvement in pain and weakness requiring analgesics with lifestyle restrictions), and poor (no improvement in preoperative pain and weakness). In the group of patients with type I herniations (33 patients), 17 patients had excellent results, 11 had good results, 4 had fair results, and 1 had a poor result. Of the 17 patients in the anterior fusion group, 11 patients had excellent results, 5 had good results, and 1 a fair result. Of the 16 patients in the laminotomy-foraminotomy group, 6 patients had excellent results, 6 patients had good results, 3 patients had fair results, and 1 patient had a poor result. Comparing the two groups, excellent-good results were noted in 94% (16 of 17) in the anterior fusion group while in the laminotomy-foraminotomy group, excellent-good results were noted in 75% (12 of 16). In the type II group, 6 patients had excellent results, 4 patients had good results, and 1 patient had a fair result (excellent-good 90% [10 of 11]). Results show that 1) although both anterior fusion and cervical laminotomy-foraminotomy provide satisfactory results in the surgical management of anterolateral soft disc herniation, anterior fusion provides better long-term improvement; and 2) anterior cervical fusion provides safe and effective results for the management of central disc herniation.

Spine update. Degenerative lumbar spondylolisthesis.

Degenerative lumbar spondylolisthesis associated with spinal stenosis is a common condition of the aging spine. This article presents a detailed description of the pathophysiology, clinical presentation, and nonoperative and operative intervention of this condition.