Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?

BACKGROUND: Standalone interspinous process devices (IPDs) to treat degenerative lumbar spinal stenosis with neurogenic intermittent claudication (NIC) have shown ambiguous results in the literature. OBJECTIVE: To show that a minimally invasive percutaneous IPD is safe and noninferior to standalone decompressive surgery (SDS) for patients with degenerative lumbar spinal stenosis with NIC. METHODS: A multicenter, international, randomized, controlled trial (RCT) was con- ducted. One hundred sixty-three patients, enrolled at 19 sites, were randomized 1:1 to treatment with IPD or SDS and were followed for 24 mo. RESULTS: There was significant improvement in Zurich Claudication Questionnaire physical function, as mean percentage change from baseline, for both the IPD and the SDS groups at 12 mo (primary endpoint) and 24 mo (-32.3 ± 32.1, -37.5 ± 22.8; and -37.9 ± 21.7%, -35.2 ± 22.8, both P < .001). IPD treatment was not significantly noninferior (margin: 10%) to SDS treatment at 12 mo (P = .172) but was significantly noninferior at 24 mo (P = .005). Symptom severity, patient satisfaction, visual analog scale leg pain, and SF-36 improved in both groups over time. IPD showed lower mean surgical time and mean blood loss (24 ± 11 min and 6 ± 11 mL) compared to SDS (70 ± 39 min and 189 ± 148 mL, both P < .001). Reoperations at index level occurred in 18.2% of the patients in the IPD group and in 9.3% in the SDS group. CONCLUSION: Confirming 3 recent RCTs, we could show that IPD as well as open decompression achieve similar results in relieving symptoms of NIC in highly selected patients. However, despite some advantages in secondary outcomes, a higher reoperation rate for IPD is confirmed.

Role of a collagen membrane in adhesion prevention strategy for complex spinal surgeries.

PURPOSE: Following lumbar spine surgery, postoperative complications can appear, including epidural adhesions. The formation of fibrosis around the dura mater can, on the one hand, lead to compression of the nerve roots with recurrent radicular pain and, on the other hand, can increase the risks of specific complications at spinal re-intervention (haematomas and dural breaches). The aim of this prospective monocentric study was to assess the safety of a new collagen antiadhesion membrane in vertebral osteotomy surgery where scar tissue and adhesions are important. METHODS: Twenty-six patients consecutively operated for lumbar posterior subtraction osteotomy with implantation of a collagen-based anti-adhesion membrane were evaluated. Membrane tolerance was evaluated at the short and midterm during the regular follow-up. RESULTS: At six months' follow-up, postoperative pain [visual analogue scale (VAS)] and disability (Oswestry Disability Index score) were significantly reduced 33.1 and 43.1%, respectively. These results were confirmed at 12-months' follow-up, with a decrease in pain of 39.9% and in disability of 49.3%. Amongst the observed postoperative complications was neither spinal fluid leak nor durotomy. Presence of the membrane was not related to complications. Two patients required further surgery for infection and nonunion at the osteotomised level. Adhesions to the dura mater were limited and thin, facilitating exposure. CONCLUSIONS: This study shows good tolerance of the collagen based membrane for spinal osteotomy and its satisfactory use for preventing postoperative epidural adhesions. Good surgical practice associated with an anti-adhesion barrier may decrease fibrosis formation and improve postoperative functional results.

Iliac crest bone graft donor site pain after anterior lumbar interbody fusion: a prospective patient satisfaction outcome assessment.

BACKGROUND: Autogenous iliac crest bone is the gold-standard graft for spinal fusion surgery. Unfortunately, there is a frequent incidence of graft site pain that persists well into the postoperative period with complication rates reported in 2.8-39% of patients. Persistent pain lasting at least 2 years is reported in 15-39% of patients. OBJECTIVE: The objective of this work was to determine the incidence of acute and persistent pain as well as patient assessment of graft site appearance following iliac crest bone graft harvest for anterior lumbar interbody fusion (ALIF). The control arms of four randomized prospective multicenter clinical trials evaluating recombinant human bone morphogenetic protein-2 (rhBMP-2) versus autogenous iliac crest bone graft were combined. Two hundred eight patients underwent iliac crest bone graft harvest for ALIF in threaded cylindrical cages or threaded bone dowels. Patients were assessed at each postoperative visit with questionnaires evaluating graft site pain intensity, duration, and appearance. METHODS: Two hundred eight patients underwent iliac crest bone graft harvest for ALIF as the control group of four randomized prospective multicenter clinical trials evaluating rhBMP-2 versus autogenous iliac crest bone graft in threaded cylindrical cages or threaded bone dowels. Most patients in the control group had anterior iliac crest graft harvest, equally from the right and left side. Three grafts (1.4%) were taken from the posterior crest and six (2.9%) were tricortical. Follow-up was obtained at hospital discharge, 6 weeks, 3, 6, 12, and 24 months. A pain evaluation score was made up of two Visual Analog Scales: one scale measuring intensity, the other frequency of pain. For the intensity scale, a rating of "0" meant no pain and "10" was "as bad as it could be." For the frequency scale, a rating of "0" meant pain was present "none of the time" and "10" meant it was present "all the time." Combining these scales, a total score of 20 indicated the worst pain was present all the time. Patients were also questioned about the graft site appearance. RESULTS: Two hundred eight patients underwent iliac crest harvest, and prospective data were available on 202 patients. At hospital discharge, 2 patients (1%) had no pain; this increased to 34 of 199 (17%) at 6 weeks postoperatively and to 85 of 199 patients (43%) at 3 months. However, 41% of patients reported pain at 6 months postoperatively (79/192), and 33% of 168 reported pain at 1 year. One hundred forty-one of 208 patients completed a survey at 24 months, with 31% reporting some level of pain. At hospital discharge, the graft site pain score ranged from 0 to 20 with a mean of 12.8, decreasing to 7.3 at 6 weeks, to 3.8 at 3 months, and to 2.9, 2.4, and 1.8 at 6, 12, and 24 months, respectively. At all time intervals, P values from t tests comparing the mean with 0 were <0.001. Graft site appearance at discharge was good in 49% of patients, fair in 40%, and poor in 11%. At 6 weeks, appearance was good in 69%, fair in 27%, and poor in 5%; at 3 months, it was good in 75%, fair in 24%, and poor in 2%; at 6 months, it was good in 82%, fair in 15%, and poor in 3%; at 12 months, it was good in 82% and fair or poor in 19%; and at 24 months, it was good in 84% and fair or poor in 16%. There was no significant difference between posterior and anterior harvest sites or bicortical grafts, and all were included in the analysis. Right or left side demonstrated no differences. DISCUSSION: This is the first study known to the authors presenting results of prospective data collected in a multicenter study evaluating iliac crest harvest site pain, both intensity and frequency, as well as graft site appearance. The results demonstrate that 31% of patients had persistent pain at 24 months postoperatively and 16% reported fair or poor appearance of their graft site. CONCLUSIONS: Persistent donor site pain remains a problem with harvest of autogenous iliac crest bone graft for spinal fusion. This prospective study, the first such study reported for ALIF, confirms that donor site pain remains a significant postoperative management problem.

Retrograde ejaculation after anterior lumbar interbody fusion: transperitoneal versus retroperitoneal exposure.

STUDY DESIGN: In this multicenter, prospective, 2-year study, 146 male patients underwent a single-level anterior lumbar interbody fusion with a tapered threaded titanium fusion device. All the patients were advised before surgery of the risk for retrograde ejaculation. After surgery, any case of retrograde ejaculation was recorded as an adverse event, and the patient was observed up for the remainder of the study. OBJECTIVE: To determine the incidence of retrograde ejaculation in male patients treated for single-level degenerative lumbar disc disease at L4-L5 or L5-S1 with a stand-alone anterior interbody fusion using tapered, threaded titanium fusion cages. SUMMARY OF BACKGROUND DATA: The incidence of retrograde ejaculation in men after anterior lumbosacral spinal surgery has been reported to range from 0.42% to 5.9%. Various risk factors that increase the chance of retrograde ejaculation have been proposed. METHODS: In this prospective study, 146 male patients underwent an open surgical exposure of the lumbosacral junction and a single-level interbody fusion at either L4-L5 or L5-S1. Assessment of a patient's clinical outcome was based on written questionnaires at 6 weeks and then 3, 6, 12, and 24 months after surgery. Patients were questioned about adverse events at each of these assessments, and any case of retrograde ejaculation was recorded and followed. RESULTS: Retrograde ejaculation developed in 6 of the 146 men after open anterior lumbar interbody fusion surgery. Two cases (1.7%; 2/116) involved patients who underwent a retroperitoneal surgical exposure. Four cases (13.3%; 4/30) involved patients who had a transperitoneal surgical exposure. This difference is statistically significant according to Fisher's exact test (P = 0.017). At 12 months after surgery, 2 patients had resolution of their symptoms: 1 in the retroperitoneal approach group and 1 in the transperitoneal group. At the final 2-year follow-up, no changes in symptoms were reported. One patient in the retroperitoneal approach group (0.86%) and three patients in the transperitoneal group (10%) reported permanent retrograde ejaculation (P = 0.027). CONCLUSIONS: A transperitoneal approach to the lumbar spine at L4-L5 and L5-S1 has a 10 times greater chance of causing retrograde ejaculation in men than a retroperitoneal approach.