Intradiscal oxygen-ozone chemonucleolysis versus microdiscectomy for lumbar disc herniation radiculopathy: a non-inferiority randomized control trial.

BACKGROUND CONTEXT: Low back pain with or without radicular leg pain is an extremely common health condition significantly impacting patient's activities and quality of life. When conservative management fails, epidural injections providing only temporary relief, are frequently utilized. Intradiscal oxygen-ozone may offer an alternative to epidural injections and further reduce the need for microdiscectomy. PURPOSE: To compare the non-inferiority treatment status and clinical outcomes of intradiscal oxygen-ozone with microdiscectomy in patients with refractory radicular leg pain due to single-level contained lumbar disc herniations. STUDY DESIGN / SETTING: Multicenter pilot prospective non-inferiority blocked randomized control trial conducted in three European hospital spine centers. PATIENT SAMPLE: Forty-nine patients (mean 40 years of age, 17 females/32 males) with a single-level contained lumbar disc herniation, radicular leg pain for more than six weeks, and resistant to medical management were randomized, 25 to intradiscal oxygen-ozone and 24 to microdiscectomy. 88% (43 of 49) received their assigned treatment and constituted the AS-Treated (AT) population. OUTCOME MEASURES: Primary outcome was overall 6-month improvement over baseline in leg pain. Other validated clinical outcomes, including back numerical rating pain scores (NRS), Roland Morris Disability Index (RMDI) and EQ-5D, were collected at baseline, 1 week, 1-, 3-, and 6-months. Procedural technical outcomes were recorded and adverse events were evaluated at all follow-up intervals. METHODS: Oxygen-ozone treatment performed as outpatient day surgeries, included a one-time intradiscal injection delivered at a concentration of 35±3 µg/cc of oxygen-ozone by a calibrated delivery system. Discectomies performed as open microdiscectomy inpatient surgeries, were without spinal instrumentation, and not as subtotal microdiscectomies. Primary analyses with a non-inferiority margin of -1.94-point difference in 6-month cumulative weighted mean leg pain NRS scores were conducted using As-Treated (AT) and Intent-to-Treat (ITT) populations. In post hoc analyses, differences between treatment groups in improvement over baseline were compared at each follow-up visit, using baseline leg pain as a covariate. RESULTS: In the primary analysis, the overall 6-month difference between treatment groups in leg pain improvement using the AT population was -0.31 (SE, 0.84) points in favor of microdiscectomy and using the ITT population, the difference was 0.32 (SE, 0.88) points in favor of oxygen-ozone. The difference between oxygen-ozone and microdiscectomy did not exceed the non-inferiority 95% confidence lower limit of treatment difference in either the AT (95% lower limit, -1.72) or ITT (95% lower limit, -1.13) populations. Both treatments resulted in rapid and statistically significant improvements over baseline in leg pain, back pain, RMDI, and EQ-5D that persisted in follow-up. Between group differences were not significant for any outcomes. During 6-month follow-up, 71% (17 of 24) of patients receiving oxygen-ozone, avoided microdiscectomy. The mean procedure time for oxygen-ozone was significantly faster than microdiscectomy by 58 minutes (p<.0010) and the mean discharge time from procedure was significantly shorter for the oxygen-ozone procedure (4.3±2.9 hours vs. 44.2±29.9 hours, p<.001). No major adverse events occurred in either treatment group. CONCLUSIONS: Intradiscal oxygen-ozone chemonucleolysis for single-level lumbar disc herniations unresponsive to medical management, met the non-inferiority criteria to microdiscectomy on 6-month mean leg pain improvement. Both treatment groups achieved similar rapid significant clinical improvements that persisted and overall, 71% undergoing intradiscal oxygen-ozone were able to avoid surgery.

Major complications in extreme lateral interbody fusion access: multicentric study by Italian S.O.L.A.S. group.

PURPOSE: The eXtreme Lateral Interbody Fusion (XLIF) approach has gained increasing importance in the last decade. This multicentric retrospective cohort study aims to assess the incidence of major complications in XLIF procedures performed by experienced surgeons and any relationship between the years of experience in XLIF procedures and the surgeon's rate of severe complications. METHODS: Nine Italian members of the Society of Lateral Access Surgery (SOLAS) have taken part in this study. Each surgeon has declared how many major complications have been observed during his surgical experience and how they were managed. A major complication was defined as an injury that required reoperation, or as a complication, whose sequelae caused functional limitations to the patient after one year postoperatively. Each surgeon was finally asked about his years of experience in spine surgery and XLIF approach. Pearson correlation test was used to evaluate the association between the surgeon's years of experience in XLIF and the rate of major complications; a p-value of last than 0.05 was considered significant. RESULTS: We observed 14 major complications in 1813 XLIF procedures, performed in 1526 patients. The major complications rate was 0.7722%. Ten complications out of fourteen needed a second surgery. Neither cardiac nor respiratory nor renal complications were observed. No significant correlation was found between the surgeon's years of experience in the XLIF procedure and the number of major complications observed. CONCLUSION: XLIF revealed a safe and reliable surgical procedure, with a very low rate of major complications, when performed by an expert spine surgeon.

Severe Spinal Surgery Infection and Local Ozone Therapy as Complementary Treatment: A Case Report.

BACKGROUND: Infection is a serious surgical complication that significantly increases morbidity and mortality rates as well as health care expenses. Increased bacterial resistance to antibiotics makes the treatment of such events even more troublesome. OBJECTIVE: To report on a surgical infection case treated with ozone as a complementary therapy. METHODS AND MATERIALS: A female, 65 years old, submitted to a complex surgical procedure for adult kyphotic deformity correction that presented with early postsurgical infection. The patient was treated with revision surgery and antibiotics that improved the condition but were unable to delete the infection. Ozone, in its gaseous form, was injected subcutaneously and paravertebrally twice weekly for 3 weeks. RESULTS: After 3 weeks of treatment, the wound healed completely. Follow-up visits and laboratory exams for up to 1 year after surgery showed no recurrence of infection. CONCLUSIONS: Although just a single case, topical ozone therapy for surgical infections showed promising potential in this specific case.

Lumbar Lordosis Correction With Interbody Hyperlordotic Cages: Initial Experience, Learning Curve, Technical Aspects, and Complication Incidence.

BACKGROUND: Analysis of the initial experience on learning curve, technical differences and perioperative or early postoperative complications using lumbar hyperlordotic anterior and lateral interbody cages for the correction of lumbar lordosis as compared with the usage of regular lordotic cages. METHODS: Initial 21 consecutive patients were treated with 13 hyperlordotic anterior lumbar interbody fusion (ALIF) cages and 8 hyperlordotic extreme lateral interbody fusion (XLIF) cages. The mean patient age was 64 years, and the mean lumbar hypolordosis was 23°. RESULTS: No significant procedure-related technical differences were found between the hyperlordotic and nonhyperlordotic ALIF cages. Slightly significant procedure-related technical differences were found between hyperlordotic and nonhyperlordotic XLIF cages. The complication type and occurrence were comparable. CONCLUSIONS: Sagittal balance correction of lumbar lordosis using hyperlordotic ALIF and XLIF cages is a relatively safe surgical procedure with a short learning curve for those surgeons already familiar with anterior and lateral retroperitoneal procedures.

Reliability of the xipho-pubic angle in patients with sagittal imbalance of the spine.

BACKGROUND: Proximal junctional kyphosis (PJK) is a frequent complication that compromises the outcomes of spinal surgery, especially for adult deformity. To the date no single risk factor or cause has been identified that explains its occurrence. The purpose of this study was to investigate the test-retest reliability of the radiologic measurements using xipho-pubic angle (XPA) for subjects undergoing surgery for sagittal misalignment of the spine. METHODS: Retrospective observational cross-sectional study of prospectively collected data. Full-spine standing lateral radiographs of 50 patients who underwent surgery for fixed sagittal imbalance (preoperative and postoperative) were evaluated. Internal consistency, reproducibility, concurrent validity, and discriminative ability of the XPA. Two physicians measured XPA on the 100 randomly sorted and anonymized radiographs on two occasions, one week apart (test and retest conditions), were calculated for inter and intraobserver agreement. RESULTS: Test-retest reliability of XPA measurement was excellent for pre- (ICC=0.98; P=0.001) and post-surgical (ICC=0.86; P=0.001) radiographs of subjects with sagittal imbalance of the spine. XPA was able to discriminate between preoperative and postoperative radiographs F=17.924, P<0.001) in patients undergoing surgery for fixed sagittal imbalance for both raters. There were significant differences between pre- vs. postoperative XPA, pelvic tilt, lumbar lordosis and sagittal vertical axis values (all P<0.001). CONCLUSIONS: Xipho-pubic angle had fair to excellent test-retest reliability, and it did possess validity to discriminate between preoperative and postoperative radiographs in patients undergoing surgery for fixed sagittal imbalance.

Direct lesion and repair of a common iliac vein during XLIF approach.

PURPOSE: Description of a case of direct intraoperative lesion and repair of a major vascular injury of common iliac vein during an extreme lateral interbody fusion L4-L5 procedure. METHODS: A 69-year-old female who was operated for L4-L5 spondilolysthesis suffered a major vascular injury of a vein. The high cava bifurcation and inadequate pre-operative analysis of the radiological documentation resulted in the lesion. The lesion was successfully repaired and the patient did not suffer post-operative sequelae. RESULTS: The repair was successful although the index spine procedure was not ended. Detailed pre-operative planning, based on radiological examination of vascular structures, should be a mandatory step prior to this specific surgical approach. CONCLUSION: Although safer than anterior retroperitoneal approach, extreme lateral interbody fusion still bears risk for major vascular injury.

Relationship between psoas muscle dimensions and post operative thigh pain. A possible preoperative evaluation factor.

INTRODUCTION: Advanced intraoperative neuromonitoring (IONM) is used to attenuate postoperative complications and side effects of extreme lateral interbody fusion (XLIF). Specific factors relate to the presence of postoperative injury are not well understood. This study aims to identify intraoperative variables with correlations to new postoperative anterior thigh/groin sensory changes. METHODS: Twenty-nine patients with various degenerative lumbar conditions were treated with XLIF at a single institution. Mean age was 59 years, 69% were female, and 21% had undergone previous lumbar surgery. A total of 47 levels (mean 1.6, range 1-3) were treated with XLIF. Supplemental pedicle screw and rod fixation was used in 24 patients (83%). Dynamically-evoked electromyography was used in all cases. Analysis of baseline demographic and treatment variables were performed at a per patient basis (n = 29), whereas analysis of intraoperative variables were performed at a per levels treated basis (n = 47). RESULTS: Within 24 hours postoperative, 10 (34%) patients experienced anterior thigh/groin sensory changes (4 reported pain only, 5 reported pain plus other sensory changes, and 1 paresthesia without pain). Symptom resolution occurred at 1 month postoperative for 4 patients, at 3 months postoperative for 2 patients. At 3 months postoperative, 6 patients had complete symptom resolution, 3 patients had symptom improvements, and 1 patient had no change in perioperative symptoms. Psoas dimension in the lateral-latero direction were significantly smaller for patients with postoperative sensory changes (p = 0.025), and similarly, patients with postoperative sensory changes had a significantly higher ratio of psoas muscle in the anterior-posterior to lateral-latero directions (p = 0.026). CONCLUSIONS: In addition to IONM, MRI evaluation of psoas shape, position, and dimension may be of help in preoperative planning of a safe XLIF access and eventually, predict those cases with higher risk of approach-related post-operative events.

Fusion rate following extreme lateral lumbar interbody fusion.

INTRODUCTION: Lumbar fusion has been found to be a clinically effective procedure in adult patients. The lateral transpsoas approach allows for direct visualization of the intervertebral space, significant support of the vertebral anterior column, while avoiding the complications associated with the posterior procedures. The aim of this study is to determine the fusion rate of inter body fusion using computed tomography in patients treated by extreme lateral intersomatic fusion (XLIF) technique. MATERIALS AND METHODS: All patients intervened by XLIF procedure between 2009 and 2013 by a single operating team at a single institution were recruited for this study. A clinical evaluation and a CT scan of the involved spinal segments were then performed with at least 1-year follow-up following the standard clinical practice in the center. RESULTS: A total of 77 patients met inclusion criteria, of which 53 were available for review with a mean follow-up of 34.5 (12-62) months. A total of 68 (87.1 %) of the 78 operated levels were considered as completely fused, 8 (10.2 %) were considered as stable, probably fused, and 2 (2.6 %) of the operated levels were diagnosed as pseudarthrosis. When stratified by type of graft material complete fusion was obtained in 75 % of patients in which autograft was used to fill the cages, compared to 89 % of patients in which calcium triphosphate was used, and 83 % of patients in which Attrax™ was used. DISCUSSION: Reports of XLIF fusion rate in the literature vary from 85 to 93 % at 1-year follow-up. Fusion rate in our series corroborates data from previous publications. The results of this series confirm that anterior inter body fusion by means of XLIF approach is a technique that achieves high fusion rate and satisfactory clinical outcomes.

Five and ten year follow-up on intradiscal ozone injection for disc herniation.

BACKGROUND: Disc herniation is the most common cause for spinal surgery and many clinicians employ epidural steroid injections with limited success. Intradiscal injection of ozone gas has been used as an alternative to epidural steroids and surgical discectomy. Early results are positive but long-term data are limited. METHODS: One hundred and eight patients with confirmed contiguous disc herniation were treated with intradiscal injection of ozone in 2002-2003. One-hundred seven patients were available for telephone follow-up at 5 years. Sixty patients were available for a similar telephone follow-up at ten years. Patients were asked to describe their clinical outcome since the injection. Surgical events were documented. MRI images were reviewed to assess the reduction in disc herniation at six months. RESULTS: MRI films demonstrated a consistent reduction in the size of the disc herniation. Seventy-nine percent of patients had a reduction in herniation volume and the average reduction was 56%. There were 19 patients that ultimately had surgery and 12 of them occurred in the first six months after injection. One of these 12 was due to surgery at another level. Two surgeries involved an interspinous spacer indicated by stenosis or DDD. All other surgeries were discectomies. Of the patients that avoided surgery 82% were improved at 5 years and 88% were improved at 10 years. Other than subsequent surgeries, no spine-related complications were experienced. CONCLUSIONS/LEVEL OF EVIDENCE: We conclude that ozone is safe and effective in approximately 75% of patients with disc herniation and the benefit is maintained through ten years. This is a retrospective review and randomized trials are needed. CLINICAL RELEVANCE: Intradiscal ozone injection may enable patients to address their pain without multiple epidural injections and surgery. The benefit of ozone is durable and does not preclude future surgical options. The risk reward profile for this treatment is favorable.

Direct lateral access lumbar and thoracolumbar fusion: preliminary results.

PURPOSE: To describe the clinical outcomes and complications in a consecutive series of extreme lateral interbody fusion cases. METHODS: Retrospective cohort review of 97 consecutive patients from three centers with minimum 6-month follow-up (mean 12 months). Functional status was evaluated by preoperative and last follow-up Oswestry Disability Index score. Leg and back pain were evaluated by visual analog scales. Complications were recorded and permanent complications and neurological impairment was actively investigated at last follow-up. RESULTS: No permanent neurological impairment, vascular or visceral injuries were observed. Transient neurological symptoms presented in 7% of cases, all resolved within 1 month from surgery. Transient thigh discomfort was observed in 9%. Clinical success was recorded in 92% of cases. CONCLUSIONS: Extreme lateral interbody fusion is a safe and effective technique for anterior interbody fusion.

Long-term reduction in pain and disability after surgery with the interspinous device for intervertebral assisted motion (DIAM) spinal stabilization system in patients with low back pain: 4-year follow-up from a longitudinal prospective case series.

Patients with low back pain (LBP) suffer chronic disability. In 40% of LBP patients degenerative disc disease (DDD) seems to be the cause. This prospective case series assessed the efficacy of the interspinous device for intervertebral assisted motion (DIAM™) in patients with LBP resulting from DDD. All patients were initially assessed by physical examinations, magnetic resonance imaging, dynamic X-rays and provocative discography. Eligible patients (n = 52) had LBP for a minimum of 4 months, and received surgery with the DIAM™ system 2-4 weeks after diagnosis. Patients were evaluated pre-/post-operatively for pain severity using a visual analogue scale (VAS), and for dysfunction and disability with the Roland-Morris Disability Questionnaire (RMDQ). VAS and RMDQ score changes were assessed using the appropriate contrasts and Bonferroni-corrected P values. As a result, significant (P < 0.0001) pain score reductions were observed between baseline values, and 2 (3.7, 95% CI 3.1; 4.2) and 48 (3.1, 95% CI 2.5; 3.6) months follow-up (intent-to-treat population). Disability scores were significantly (P < 0.0001) reduced between baseline and 2 (8.6, 95% CI 7.4; 9.9) and 48 (7.5, 95% CI 6.1; 8.9) months. Disability scores were similar from months 2 to 48. At 48 months, 67.3% of patients reached the minimum clinically important difference (MCID; ≥1.5-unit improvement) in VAS score and 78.9% of patients reached the MCID (≥30% improvement) in RMDQ score. No complications were associated with surgery. In conclusion, patients with LBP treated with the interspinous DIAM™ system showed significant and clinically meaningful improvements in pain and disability for up to 4 years.

Percutaneous coblation nucleoplasty in patients with contained lumbar disc prolapse: 1 year follow-up in a prospective case series.

BACKGROUND: Nucleoplasty appears a successful minimally-invasive treatment for symptomatic contained disc herniation (protrusion). The purpose of this prospective study was to assess the effectiveness of nucleoplasty for alleviating pain and dysfunction in our patients. METHOD: All patients who presented with established low back and/or leg pain of at least 3 months' duration were clinically followed for 1 year following the nucleoplasty procedure. Self-reported grading of pain using the Visual Analogue Scale (VAS) and the Roland Morris Disability Questionnaire (RMDQ), and subjective global rating of overall satisfaction were recorded and analysed. RESULTS: Eighty-three patients, aged between 20 and 65 years who were treated with nucleoplasty were included in the study. No complications were noted. At the 12-month-follow-up, the median VAS and RMDQ scores were significantly reduced in the patients who were considered successful (VAS by 6-7 points, RMDQ by 8 points) compared to the patients who were considered failed showing much less reduction. (P = 0.000 in both cases; Mann-Whitney U test.) There was no significant difference in the baseline VAS and RMDQ scores in the two groups. Patients who were considered to have failed the procedure tended to be older. Multi-level disc decompression did not appear to be a risk factor for failure. CONCLUSIONS: This disc decompression procedure was a safe and effective treatment option for carefully selected patients affected by low back and leg pain due to contained disc herniation.

DIAM device for low back pain in degenerative disc disease : 24 months follow-up.

PURPOSE: To evaluate the usefulness of the DIAM device in patients affected by low back pain due to degenerative disc disease. BACKGROUND: Recently a number of interspinous devices for dynamic interspinous distraction-stabilization have entered the clinical practice in Europe. All of these devices have a common property of acting on the posterior part of the functional spinal unit by distracting the spinous processes and avoiding extension of the treated segment. Consequently, these systems seem to improve the cross-sectional area of the thecal sac and enlarge the diameter of the intervertebral foramina. What was found as a collateral observation after implantation of these devices was that those patients affected by low back pain, improved significantly in their pain level. METHODS AND MATERIALS: Fifty-two consecutive patients were included in the study. There were 29 females and 23 males, aged between 29 and 77 years (mean 49.4 ± s.d. 12.4). The pre-operative symptom duration ranged from 6 to 84 months (mean 31.8 ± s.d. 20.2, median 24 months).The following diagnostic measures were performed in each patient: MRI, dynamic X-rays and provocative discography positive for pain reproduction.The patients were followed for pain by VAS and for functional status by self-reported Roland-Morris Disability Questionnaire. The minimum follow-up was 24 months (24-36). The intermediate follow-up at 6, 12 and 18 months was tested for, too. RESULTS: To determine the number of improved patients we have arbitrarily selected a cut-off criteria based on a ≥30% of improvement as calculated on the Roland Morris Disability Questionnaire scale comparing the 24 months values to the baseline values. Forty-six patients (88%) were considered as success and 2 (4%) were considered as failure. No long-term complications were observed. CONCLUSIONS: This preliminary report indicates that the DIAM device could possibly be useful in the treatment of LBP due to DDD. Further research with RCT is necessary to confirm these preliminary results.