Robert Pflugmacher

Comparison of clinical and radiological data in the treatment of patients with osteoporotic vertebral compression fractures using radiofrequency kyphoplasty or balloon kyphoplasty

PURPOSEnSince the 1990s, balloon kyphoplasty has been proven as an effective method of treating patients with painful vertebral compression fractures (VCF). The radiofrequency kyphoplasty is an innovative procedure available since 2009, for which an ultra-high viscosity cement is used. For the statistical comparison of the two methods of augmentation, the clinical and radiological data of 2 larger patient groups were evaluated.nnnMATERIALS AND METHODSnAs part of the surgical treatment of patients with conservative therapy-resistant osteoporotic vertebral fractures, a prospective study of radiofrequency kyphoplasty (RFK) was performed between 2009 and September 2010. The treatment was minimally invasive using the StabiliT® Vertebral Augmentation System by DFine for which the StabiliT® multiplex controller, the articulating VertecoR® Midline Osteotome, and the radiofrequency-sensitive StabiliT® ER2 bone cement were applied. From the clinical aspect, measurement parameters for efficacy and safety were the course of pain intensity using a visual analogue scale (VAS: 0 to 100u2009mm) and the Oswestry disability score (0-100%). For the radiological outcome the increase in the middle and anterior parts of the treated vertebra and also the reduction of kyphosis after surgery and after 6 months were evaluated. Furthermore, the extent of cement extrusion and the duration of operation time were compared. There were 2 groups of patients chosen with the same indication, and with the same average VAS prior to treatment. For the balloon kyphoplasty (BKP) the Kyphon® technology was used. For the BKP group the same parameters as in the first group were evaluated (matched pairs). To compare the data statistically, parametric and non-parametric tests were applied.nnnRESULTSnFor the radiofrequency kyphoplasty group (RFK) 114 patients were recruited, and for the balloon kyphoplasty group (BKP) 114 appropriate patients were selected. In 48% of the RFK patients and in 44% of the BKP patients more than one vertebral body were treated (thoracic or lumbar). Prior to treatment 84u2009mm on the VAS were calculated in both groups. The decrease in VAS values (RFK vs. BKP) immediately after surgery was 58.8 vs. 54.7u2009mm (pu2009=u20090.02), and 73.0 vs. 58.9u2009mm after 6 months (pu2009<u20090.001). In both groups improvements in the Oswestry scores were registered after 6 months without a statistically significant difference. In both groups, the middle part of the vertebral bodies was increased by an average of 3.1u2009mm. RFK yielded a decrease in the average kyphosis angle of 4.4, the BKP resulted in about 3.8 degrees. Concerning cement leakage a key difference in favor of the radio frequency kyphoplasty was detected (6.1u200a% vs. 27.8%; pu2009<u20090.0001). For RFK a significant shorter duration of operation time was calculated (28.2 vs. 49.6u2009min; pu2009<u20090.001).nnnCONCLUSIONSnThe RFK has proven to be a clinically very effective procedure that does somewhat better than BKP in long-lasting pain relief. No differences could be detected regarding improvement of functioning and the mean restoration of mid- and anterior vertebral height. As far as the safety aspect is concerned the RFK offers the advantage of a statistically significant lower proportion of cement extrusion.

Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management

PurposeTo compare the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) using triangular titanium implants vs conservative management (CM) in patients with chronic sacroiliac joint (SIJ) pain.Methods103 adults with chronic SIJ pain at nine sites in four European countries were randomly assigned to and underwent either minimally invasive SIJF using triangular titanium implants (Nxa0=xa052) or CM (Nxa0=xa051). CM was performed according to the European guidelines for the diagnosis and management of pelvic girdle pain and consisted of optimization of medical therapy, individualized physical therapy (PT) and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated low back pain (LBP) at 6xa0months. Additional endpoints included quality of life using EQ-5D-3L, disability using Oswestry Disability Index (ODI), SIJ function using active straight leg raise (ASLR) test and adverse events. NCT01741025.ResultsAt 6xa0months, mean LBP improved by 43.3 points in the SIJF group and 5.7 points in the CM group (difference of 38.1 points, pxa0<xa00.0001). Mean ODI improved by 26 points in the SIJF group and 6 points in the CM group (pxa0<xa00.0001). ASLR, EQ-5D-3L, walking distance and satisfaction were statistically superior in the SIJF group. The frequency of adverse events did not differ between groups. One case of postoperative nerve impingement occurred in the surgical group.ConclusionsIn patients with chronic SIJ pain, minimally invasive SIJF using triangular titanium implants was safe and more effective than CM in relieving pain, reducing disability, improving patient function and quality of life.

Continuing conservative care versus crossover to radiofrequency kyphoplasty: a comparative effectiveness study on the treatment of vertebral body fractures

BackgroundThere is controversy about how to treat vertebral fractures. Conservative care is the default approach. Radiofrequency kyphoplasty uses ultrahigh viscosity cement to restore spinal posture and stabilize the fracture. The aims of this study were to compare radiofrequency kyphoplasty to conservative care and assess the usual algorithm of starting all patients on conservative care for 6xa0weeks before offering surgery.MethodsElderly patients with painful osteoporotic vertebral compression fractures were all treated with 6xa0weeks of conservative care (analgesics, bracing, and physiotherapy). They were then offered the choice of continuing conservative care or crossing over to radiofrequency kyphoplasty, at 6 and 12xa0weeks. Clinical success was defined as: (1) VAS pain improvement ≥2, (2) final VAS pain ≤5, (3) no functional worsening on ODI.ResultsAfter the initial 6xa0weeks of conservative care, only 1 of 65 patients met the criteria for clinical success, and median VAS improvement was 0. After 12xa0weeks of conservative care, only 5 of 38 patients met the criteria for clinical success, and median VAS improvement was 1. At the 6-week follow-up after radiofrequency kyphoplasty, 31 of 33 surgery patients met the criteria for clinical success, and median VAS improvement was 5.ConclusionFor the vast majority of patients with a VAS ≥5, conservative care did not provide meaningful clinical improvement. In contrast, nearly all patients who underwent radiofrequency kyphoplasty had rapid substantial improvement. Surgery was clearly much more effective than conservative care and should be offered to patients much sooner.

PMMA-augmentation of incompletely cannulated pedicle screws: A cadaver study to determine the benefits in the osteoporotic spine

BACKGROUNDnPedicle screw pullout due to poor bone quality, mainly caused by osteoporosis, is a common problem in spine surgery. Special implants and techniques, especially PMMA augmentation, were developed to improve the fixation of pedicle screws. PMMA injection into a pilot hole or through a screw involves the same risks as vertebroplasty or kyphoplasty, regardless of the technique used. Especially when using fully cannulated screws anterior leakage is possible.nnnOBJECTIVEnTo prove PMMA injection is safe and possible without leakage through an incompletely cannulated screw and also increases pullout forces in the osteoporotic vertebra.nnnMETHODSnIncompletely cannulated pedicle screws were tested by axial pullout in human cadavers, divided into osteoporotic and non-osteoporotic groups. Non-augmented and PMMA-augmented pedicle screws were compared. Twenty-five human vertebrae were measured by DEXA and divided into osteoporotic and non-osteoporotic groups. In each vertebra both pedicles were instrumented with the new screw (WSI-Expertise 6×45 mm, Peter Brehm Inc. Germany); the right screw was augmented with a 3 mL PMMA injection through the screw. On each screw axial pullout was performed after X-ray and CT scan.nnnRESULTSnRadiographs and CT scans excluded PMMA leakage. Cement was distributed in the middle and posterior third of the vertebrae. Pullout forces were significantly higher after pedicle screw augmentation, especially in the osteoporotic bone. All augmented pedicle screws showed higher pullout forces compared with the unaugmented screws.nnnCONCLUSIONSnWe minimized the risk of leakage by using a screw with a closed tip. On the whole, PMMA augmentation through an incompletely cannulated pedicle screw is safe and increases pullout forces in osteoporotic bone to the level of healthy bone. Therefore the new incompletely cannulated screw can be used for pedicle screw augmentation.

Influence of smoking on spinal fusion after spondylodesis surgery: A comparative clinical study

BACKGROUNDnSmoking is a risk factor in the process of bone healing after lumbar spondylodesis, often associated with complications that occur intraoperatively or during follow-up periods.nnnOBJECTIVEnTo assess if smokers yield worse results concerning lumbar interbody fusion than non-smokers in a clinical comparative setting.nnnMETHODSnSpondylodesis outcomes in 50 patients, 34 non-smokers (mean 58 years; (range 29-81) and 16 smokers (mean 47 years; range 29-75) were compared preoperatively and one year after spondylodesis surgery using Oswestry-Disability-Index (ODI), visual analogue scale (VAS) and radiological outcome analysis of fusion-success.nnnRESULTSnSmokers showed a comparable ODI-improvement (p = 0.9343) and pain reduction to non-smokers (p = 0.5451). The intake of opioids was only reduced in non-smokers one year after surgery. Fusion success was significantly better in non-smokers (p = 0.01).nnnCONCLUSIONSnThe results indicate that smoking adversely effects spinal fusion. Particularly re-operations caused by pseudarthrosis occur at a higher rate in smokers than in non-smokers.

Treatment options for vertebral fractures an overview of different philosophies and techniques for vertebral augmentation.

PurposeFor more than 30xa0years, minimally invasive surgical procedures have been available to stabilize the fractured vertebrae by cement augmentation leading to significant pain relief, a distinct improvement in quality of life and decreased mortality for patients suffering from osteoporotic vertebral compression fractures. This overview article is designed to provide information on the wide range of augmentation methods previously tested and clinically applied in surgery in an attempt to compile the clinically relevant information on safety and efficacy in the published literature.MethodBased on an extensive literature review on the topic of “vertebral fractures—surgical augmentation techniques” we summarized the results of published clinical trials and experimental testing which address clinically relevant questions. The selection of the publications in reference books and scientific journals covers the time period from the end of the 1970s until the present.ResultsThe final selection of more than 50 publications with, in the opinion of the authors, clinically relevant data led to the following results, which can be of significance for clinical application. The prerequisites for the success of all augmentation methods include the earliest possible surgical intervention, optimal technical equipment and an experienced, interdisciplinary team, as well as thorough consideration of the situation of the individual patient. The selection of the material for vertebral augmentation depends on the surgical method. The material of choice remains polymethylmethacrylate (PMMA), and the best record of efficacy and safety is displayed by radiofrequency kyphoplasty with ultrahigh-viscosity cement. Regarding clinical efficacy and safety, there are many convincing documentations showing superiority of vertebroplasty and kyphoplasty in comparison with conservative therapeutic regimens. Initial results of clinical studies with additional implants indicate a trend toward further improvement in clinical success and suggest possible broader clinical possibilities of application.ConclusionModern, minimally invasive augmentation techniques represent a real alternative to conservative treatment of patients with vertebral fractures. Further technical and clinical development in this area should aim at optimizing procedural safety while continuing to achieve comparably good results to current methods. Minimizing damage to the remaining trabecular structures as well as to adjacent vertebral disks and vertebrae should be paramount of importance.SummaryOptions for the treatment of vertebral fractures: Reductions in bone density and pathological changes in bone structure are associated with an elevated risk of fractures, which can lead to decisive functional impairment, pain, and a host of further comorbidities. Vertebral augmentation can be considered as an alternative conservative treatment, in order to achieve immediate and lasting pain relief as well as improvement in functional impairment. To achieve greater safety, instrumentation for transpedicular access and incorporation of radiopacifiers in PMMA for vertebroplasty were developed in mid-eighties. Balloon kyphoplasty was introduced in the end nineties, and results of prospective, randomized clinical studies have confirmed the safety and efficacy; the destruction of the remaining native spongiosa structures during balloon expansion is viewed as a disadvantage of this method. The two step method of cavity creation followed by cement delivery known as kyphoplasty has been further refined and developed by and varied by technology/procedural developments. This includes most the radiofrequency kyphoplasty (DFINE Inc., San Jose, CA, USA), in which ultrahigh-viscosity cement is delivered at a controlled delivery rate, following producing a bone sparing size and side specific cavity which minimizes loss of spongiosa, allowing for mechanical stability upon interdigitation of cement into that remaining trabecular bone. This combination has been shown to preserve vertebral structures and reduces the risk of leakages. Finally, systems have been available in which cement augmentation of implants to enhance mechanical stability of the implants or the overall fracture is constructed by load sharing.

CT-guided infiltration saves surgical intervention and fastens return to work compared to anatomical landmark-guided infiltration in patients with lumbosciatica

AbstractBackgroundnInfiltration procedures are a common treatment of lumbar radiculopathy. There is a wide variety of infiltration techniques without an established gold standard. Therefore, we compared the effectiveness of CT-guided transforaminal infiltrations versus anatomical landmark-guided transforaminal infiltrations at the lower lumbar spine in case of acute sciatica at L3–L5.MethodsA retrospective chart review was conducted of 107 outpatients treated between 2009 and 2011. All patients were diagnosed with lumbar radiculopathic pain secondary to disc herniation in L3–L5. A total of 52 patients received CT-guided transforaminal infiltrations; 55 patients received non-imaging-guided nerve root infiltrations. The therapeutic success was evaluated regarding number of physician contacts, duration of treatment, type of analgesics used and loss of work days. Defined endpoint was surgery at the lower lumbar spine.ResultsIn the CT group, patients needed significantly less oral analgesics (pxa0<xa00.001). Overall treatment duration and physician contacts were significantly lower in the CT group (pxa0<xa00.001 and 0.002) either. In the CT group, patients lost significant fewer work days due to incapacity (pxa0<xa00.001). Surgery had to be performed in 18.2xa0% of the non-imaging group patients (CT group: 1.9xa0%; pxa0=xa00.008).ConclusionThis study shows that CT-guided periradicular infiltration in lumbosciatica caused by intervertebral disc herniation is significantly superior to non-imaging, anatomical landmark-guided infiltration, regarding the parameters investigated. The high number of treatment failures in the non-imaging group underlines the inferiority of this treatment concept.

Comparison of Radiofrequency-targeted Vertebral Augmentation with Balloon Kyphoplasty for the Treatment of Vertebral Compression Fractures: 2-year Results.

Study Design: A retrospective study. Objectives: The aim of this study was the evaluation of the safety and effectiveness of radiofrequency-targeted vertebral augmentation (RF-TVA) in comparison with balloon kyphoplasty (BK) for the treatment of acute painful vertebral compression fractures (VCFs) on the basis of matched pairs. Summary of Background: Vertebroplasty and BK are the common surgical interventions for the treatment of VCF. Both are effective and safe but pose some risks such as adjacent fractures and cement leakage. In 2009, RF-TVA was introduced as an innovative augmentation procedure for the treatment of VCF. Materials and Methods: A total of 192 patients (116 female; 51–90 y) with VCF (n=303) at 1 to 3 levels were treated with RF-TVA or BK. Functionality (Oswestry Disability Index), pain (visual analogue scale), vertebral height (anterior, middle), and kyphotic angle were evaluated over a 2-year period (postoperatively, 3–4 d, 3, 6, 12, and 24 mo). In addition, operating time and occurrence of cement leakage were recorded. Results: Pain and functionality were significantly improved after both treatments. In both groups, there was an increase in the vertebral height and a decrease in the kyphotic angle, which remained relatively consistent during 24 months. The incidence of cement leakage was 9.4% (n=9) in the RF-TVA group and 24.0% (n=25) in the BK group. The mean operating time with radiofrequency kyphoplasty was 25.9±9.9 minutes, and with balloon kyphoplasty 48.0±18.4 minutes. Conclusions: RF-TVA is a safe and effective procedure for the treatment of vertebral compression fractures when compared with BK. Improvement in pain and functional scores after RF-TVA are durable through 24 months postprocedure and remained better than those after BK at long-term follow-up. Operating time for RF-TVA is shorter and the risk of cement leakage is lower. Both procedures provided similar results in vertebral height restoration and reduction in the kyphotic angle.

Temperature distribution during radiofrequency ablation of spinal metastases in a human cadaver model: Comparison of three electrodes

BACKGROUNDnRadiofrequency ablation (RFA) temperatures reaching 45°C in adjacent tissues are cytotoxic to the spinal cord, nerves and surrounding tissues.nnnOBJECTIVEnThis study compares different RFA electrodes with regard to the temperature distribution during ablation of spinal metastases.nnnMETHODSnIn vitro experimental study in isolated lumbar vertebrae of a human cadaveric spine. The temperature distribution of RFA electrodes was measured during ablation in human cadaveric lumbar vertebrae containing a simulated vertebral body lesion. The analysis compared a novel bipolar RFA electrode with two conventional monopolar RFA electrodes. A vertebral metastasis model was prepared in eight lumbar vertebrae for each electrode. Differences between the electrodes were evaluated with a one-way ANOVA.nnnRESULTSnThe lowest temperature at the thermocouples adjacent to the simulated lesion was achieved when using the bipolar RFA electrode (46.4 ± 3.3°C), but temperature difference to the monopolar RFA electrodes was not significant. In the neural foramen and epidural space of lumbar vertebrae the maximal temperature measured when using the bipolar RFA electrode was 37.0 ± 0°C and 37.3 ± 0.7°C, which was significantly lower than during ablation via either of the monopolar RFA electrodes (p ≤ 0.001).nnnCONCLUSIONSnTemperatures in areas of adjacent tissue during RFA using a specific for spinal ablation designed electrode with integrated thermocouples were significantly lower compared to other electrodes, potentially reducing temperature related risks during ablation.

Radiofrequency-activated PMMA-augmentation through cannulated pedicle screws: A cadaver study to determine the biomechanical benefits in the osteoporotic spine

INTRODUCTIONnPMMA-augmentation of pedicle screws strengthens the bone-screw-interface reducing cut-out risk. Injection of fluid cement bears a higher risk of extravasation, with difficulty of application because of inconsistent viscosity and limited injection time.nnnOBJECTIVEnTo test a new method of cement augmentation of pedicle screws using radiofrequency-activated PMMA, which is suspected to be easier to apply and have less extravasations.nnnMETHODSnTwenty-seven fresh-frozen human cadaver lumbar spines were divided into 18 osteoporotic (BMD ≤ 0.8 g/cm2) and 9 non-osteoporotic (BMD > 0.8 g/cm2) vertebral bodies. Bipedicular cannulated pedicle screws were implanted into the vertebral bodies; right screws were augmented with ultra-high viscosity PMMA, whereas un-cemented left pedicle screws served as negative controls. Cement distribution was controlled with fluoroscopy and CT scans. Axial pullout forces of the screws were measured with a material testing machine, and results were analyzed statistically.nnnRESULTSnFluoroscopy and CT scans showed that in all cases an adequately big cement depot with homogenous form and no signs of extravasation was injected. Pullout forces showed significant differences (p < 0.001) between the augmented and non-augmented pedicle screws for bone densities below 0.8 g/cm2 (661.9 N ± 439) and over 0.8 g/cm2 (744.9 N ± 415).nnnCONCLUSIONSnPullout-forces were significantly increased in osteoporotic as well as in non-osteoporotic vertebral bodies without a significant difference between these groups using this standardized, simple procedure with increased control and less complications like extravasation.