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.

Treatment of Osteoporotic Vertebral Compression Fractures: Applicability of Appropriateness Criteria in Clinical Practice.

BACKGROUND: Appropriate treatment choice for osteoporotic vertebral compression fractures (OVCF) is challenging due to patient heterogeneity. Using the RAND/UCLA method, an international multidisciplinary expert panel established patient-specific criteria for the choice between non-surgical management (NSM), vertebroplasty (VP), and balloon kyphoplasty (BKP). OBJECTIVES: To assess the applicability of the appropriateness criteria in real-life practice. STUDY DESIGN: Prospective observational study. SETTING: Eight practices of experts who participated in the panel study, including 2 interventional radiologists, one internal medicine specialist, 2 neurosurgeons, and 3 orthopedic/trauma surgeons. Practices were located in Belgium, Germany, Italy, Switzerland, and the United Kingdom. METHODS: Using an online data capture program, participants documented the clinical profile (age, gender, previous VCFs, time since fracture, magnetic resonance imaging (MRI) findings, evolution of symptoms, impact of symptoms on quality of life, spinal deformity, ongoing fracture process, and presence of pulmonary dysfunction) and treatment choice for consecutive patients who consulted them for OVCF. RESULTS: In total 426 patients were included. BKP was the most frequently chosen treatment option (49%), followed by VP (34%) and NSM (14%). When compared with the panel recommendations, inappropriate treatment choices were rare (5% for NSM, 2% for VP, none for BKP). Treatment choice was strongly associated with the clinical variables used in the panel study. Differences in treatment decisions between interventional radiologists and surgeons were largely determined by differences in patient characteristics, with time of clinical presentation being the dominant factor. LIMITATION: The study population was restricted to the practices of the participants of the panel study. CONCLUSION: This international, multi-specialty utilization review showed excellent applicability of, and good adherence with RAND/UCLA-based recommendations on treatment choice in OVCF.

Extreme lateral interbody fusion (XLIF®): how I do it.

BACKGROUND: First introduced by Pimenta et al. in 2001, the extreme lateral interbody fusion (XLIF®) approach is a safe and effective alternative to anterior or posterior approaches to lumbar fusion, avoiding the large anterior vessels and posterior structures including the paraspinous muscles, facet joint complexes and tension bands. METHOD: The authors provide a detailed description of the surgically relevant anatomy focusing on the close relationship among the lumbar plexus, psoas muscle and lateral spinal column. The surgical technique is detailed step by step, stressing how to avoid complications. A video clip of an XLIF is provided, and important perioperative considerations are listed in detail. CONCLUSION: The XLIF® approach is a safe procedure allowing an approach to the lateral lumbar spine. Nevertheless, the surgeon's knowledge of anatomical landmarks, response to visual and tactile cues, and intraoperative decision-making skills remain of paramount importance. KEY POINTS: • Correct lateral positioning with an orthogonal orientation of the corresponding lumbar vertebral body is of key importance. • Subsequent table repositioning for every level is advised in multilevel cases. • Posterior structures including the paraspinous muscles, facet joint complexes and tension bands are mostly preserved. • Meticulous preoperative planning of the psoas docking point, considering all level-specific vascular and neuronal elements, is of paramount importance. • In general, concavity is recommended for the selection of the approach side. • A careful endplate and contralateral preparation and release are mandatory in order to allow bony fusion and maximum indirect foraminal decompression. • Using a perioperative dexamethasone bolus seems to be effective at the L4/5 level to reduce postoperative plexopathy. • Overdistraction should be avoided in order to prevent cage subsidence. • A major disadvantage is the relatively high, but mostly only transient, incidence of psoas weakness as well as hip-groin-thigh pain, dysaesthesia and/or numbness. • Major advantages include indirect neurological decompression, minimal blood loss, shorter operation times, decreased overall infection rates and more surface for bony fusion.

Criteria for the appropriate treatment of osteoporotic vertebral compression fractures.

BACKGROUND: The heterogeneity of patients with osteoporotic vertebral compression fractures (VCF) necessitates a tailored approach of balancing the benefits and limitations of available treatments. Current guidelines are divergent, sometimes contradictory, and often insufficiently detailed to guide practice decisions. OBJECTIVES: This study aimed at establishing treatment recommendations at the patient-specific level. STUDY DESIGN: Using the RAND/UCLA Appropriateness Method (RAM), the appropriateness of different treatment options for osteoporotic VCFs was assessed. SETTING: The assessment was conducted by a European multidisciplinary panel of 12 experts. METHODS: The appropriateness of non-surgical management (NSM), vertebroplasty (VP), and balloon kyphoplasty (BKP) was determined for 128 hypothetical patient profiles. These were unique combinations of clinical factors considered relevant to treatment choice (time since fracture, MRI findings, impact and evolution of symptoms, spinal deformity, ongoing fracture process, and pulmonary dysfunction). After 2 individual rating rounds and plenary meetings, appropriateness statements (appropriate, inappropriate, and uncertain) were calculated for all clinical scenarios. RESULTS: Disagreement dropped from 31% in the first round to 7% in the second round. Appropriateness outcomes showed specific patterns for the 3 treatments. For three-quarters of the profiles, only one treatment was considered appropriate: NSM 25%, VP 6%, and BKP 45%. NSM was usually appropriate in patients with a negative MRI or a positive MRI without other unfavorable conditions (poor outcomes for the other variables). VP was usually appropriate in patients with a positive MRI, time since fracture ≥ 6 weeks, and no spinal deformity. BKP was recommended for all patients with an ongoing fracture process, and also in most patients with a positive MRI and ≥ 1 other unfavorable factor. LIMITATIONS: The prevalence of the patient profiles in daily practice is yet unknown. CONCLUSION: The panel results may help to support treatment choice in the heterogeneous population of patients with osteoporotic VCF.

The surgeon's real dose exposure during balloon kyphoplasty procedure and evaluation of the cement delivery system: a prospective study.

PURPOSE: Balloon kyphoplasty is currently widely used for the treatment of vertebral compression fractures (VCFs). Procedure safety is directly linked to precise radiological imaging generated by various X-ray systems (C-arm, O-arm, angiography table, etc.). This minimally invasive spinal surgery is, by definition, associated with significant radiation exposure for both patient and surgeon. Real dose exposure received by the surgeon is usually difficult to precisely record. In our center, all Balloon Kyphoplasty Procedures (BKP) are now performed using an O-arm image guidance system to control cement augmentation in VCF. Our preliminary experience described reduced dose exposure compared to C-arm guided procedures. We present here an additional way to considerably reduce the amount of radiation received by the surgeon during BKP using a new injection system. METHODS: We prospectively evaluated O-arm guided BKP in 20 consecutive patients alternatively allocated to either classic O-arm BKP with direct bone filler injection or BKP using a new Cement Delivery System (CDS). Eye, wrist, finger and leg measurements were taken bilaterally and compared between the two groups. RESULTS: The radiation dose received by the surgeon's finger, wrist and leg was reduced by greater than 80% when using the CDS. It allows the surgeon to work way below the most severe annual limit of dose exposure, which may not be the case when using a classical bone filler direct injection mechanism. CONCLUSION: We believe that when using this new intraoperative injection system, the surgeon's overall anatomic exposure is significantly reduced without compromising the critical procedure steps.

O-arm-guided balloon kyphoplasty: prospective single-center case series of 54 consecutive patients.

BACKGROUND: Balloon kyphoplasty is widely used to treat vertebral compression fractures. Procedure outcome and safety are directly linked to precise radiological imaging requiring 1 or 2 C arms to allow correct visualization throughout the procedure. This minimally invasive spinal surgery is associated with radiation exposure for both patient and surgeon. In our center, we switched from using a C-arm to an O-arm image guidance system to perform balloon kyphoplasty. Our preliminary experience is reported in Acta Neurochirurgica, and the encouraging results led us to study this subject more extensively. This article presents our complete results. To the best of our knowledge, there is no comparable clinical series describing O-arm use in kyphoplasty procedures published in the literature. OBJECTIVE: To report our complete results of using the O-arm guidance system to perform balloon kyphoplasty. METHODS: We prospectively evaluated O-arm-guided kyphoplasty procedure in 54 consecutive patients and measured x-ray exposure and fluoroscopy time. RESULTS: The mean surgical time for the procedure was 38 minutes with a mean fluoroscopy procedure time of 3.1 minutes. The mean fluoroscopy time by level was 2.5 minutes. Mean irradiation dose by procedure was 220 mGy and by level was 166 mGy. There was a significant reduction in fluoroscopy time and x-ray exposure from 5.1 minutes with classic C-arm use to 3.1 minutes when with O-arm use without additional time required for positioning the system. CONCLUSION: With this new intraoperative system, the overall surgical and fluoroscopy times can be further reduced in the near future.

O-arm guided balloon kyphoplasty: preliminary experience of 16 consecutive patients.

Balloon kyphoplasty is now widely used for the treatment of vertebral compression fractures. Excellent pain relief is achieved with cement injection, but the safety of the procedure relays on excellent radiological exposure. The balloon kyphoplasty technique is usually performed using one or two C-Arm devices to allow correct antero-posterior (AP) and lateral view throughout the surgical procedure. By definition, this minimal invasive spine surgery is associated with radiation exposure for both the patient and the surgeon. In our center, we recently moved from this way of proceeding to the use of an O-Arm image guidance system to perform cement augmentation in vertebral fractures. To our knowledge, there is no clinical series describing the O-arm use in a balloon kyphoplasty procedure published in the scientific literature. We prospectively evaluate on 16 consecutive patients, the feasibility of the O-Arm guided kyphoplasty procedure with the original, usual tools, and we measured the fluoroscopy time and the X-ray exposure. We didn't experience any device related problem and demonstrated a significant reduction of X-ray exposure and time of fluoroscopy. We believe that using this new intraoperative system, the overall time of surgery and fluoroscopy could still be reduced in a near future.

Implantation of an empty carbon fiber cage or a tricortical iliac crest autograft after cervical discectomy for single-level disc herniation: a prospective comparative study.

OBJECT: The authors conducted a study to evaluate and compare prospectively the implantation of either an empty carbon fiber composite frame cage (CFCFC) or an iliac crest autograft after anterior cervical discectomy (ACD) for cervical disc herniation with monoradiculopathy. METHODS: Thirty-six consecutive patients with one-level radiculopathy due to single-level cervical disc herniation were treated by ACD, and implantation of either an empty CFCFC (24 patients) or an iliac crest autograft (12 patients). Radiological and clinical assessments were performed preoperatively, immediately postoperatively, and at 3, 6, and 12 months postoperatively. Fusion at the 12-month follow-up examination was demonstrated in 96% of the patients in the cage group and in 100% of those in the autograft group. The mean anterior intervertebral body height was 3.7 mm preoperatively and 3.9 mm at 12 months in the CFCFC, and 4.1 and 3.8 mm, respectively, in the autograft group. In cage-treated patients, neck pain, as measured using the visual analog scale (VAS) (Score 0 = minimum; 10 = maximum) decreased from 6.4 preoperatively to 2.0 at 12 months, and radicular pain decreased from 8.4 preoperatively to 1.5 at 12 months. In the autograft group, neck pain changed from a mean preoperative VAS score of 7.2 to 2.5 at 12 months, and radicular pain decreased from a preoperative mean of 7.8 to 1.4 at 12 months. Analysis of the 12-Item Short Form Health Survey domains and the Oswestry Disability Index scores indicated a significant improvement in both the Physical and Mental Component Summary domains in both groups. CONCLUSIONS: Implantation of an empty CFCFC or a tricortical iliac crest autograft after ACD are safe and reliable options for the treatment of cervical disc herniation causing one-sided radiculopathy. Both procedures produced equally satisfying clinical and radiological results, leading to a high fusion rate and maintaining intervertebral height. Implantation of an empty CFCFC has the advantages of avoiding any donor site morbidity and requiring a significantly shorter operative time.