Prediction of immediate and long-term benefit after kyphoplasty of painful osteoporotic vertebral fractures by preoperative MRI.

BACKGROUND: It is unclear if an MR-detectable bone marrow edema is a prerequisite for pain reduction and morphological correction by kyphoplasty. This comparative trial evaluates clinical and radiomorphological outcomes after kyphoplasty of painful osteoporotic vertebral fractures with and without preoperative MR-detectable bone marrow edema for 1 year of follow-up. METHODS: Preoperative MR-images of 45 patients who received kyphoplasty for treatment of painful osteoporotic vertebral fractures were evaluated with regard to presence (n = 27) or absence (n = 18) of vertebral bone marrow edema. Pain scores (VAS 0-100) and radiomorphological measures (midline vertebral height, kyphosis angle) were analysed at baseline, postoperatively and after 12 months. RESULTS: In the "bone edema" group, pain scores improved from 72.7 to 46.8 (postoperative) and 48.0 (12 months, P < 0.001, both). In the group without preoperative bone edema, pain score improved from 70.7 to 60.3 (postoperative, P = 0.013) and to 50.1 (12 months, P = 0.001). Pain scores of both groups were significantly different directly postoperative (P = 0.026), but not after 12 months (P = 0.714). Vertebral height restoration was slightly greater in the "bone edema" group (10.2% vs. 7.8%, P = 0.289). Correction of the kyphosis angle was greater in the "bone edema" group (P = 0.014) compared to the "no bone edema" group (P = 0.838). CONCLUSION: A preoperative MR-detectable vertebral bone marrow edema predicts a better short-term outcome after kyphoplasty, but is not a prerequisite for long-term pain reduction in patients with old, chronically painful osteoporotic vertebral fractures.

Vertebroplasty and kyphoplasty - inefficient treatments for degenerative spine disease.

Osteoporotic vertebral fractures and pathological vertebral lesions are frequent clinical situations causing severe back pain. The pharmacological treatment of the underlying disease and the analgetic treatment of the associated back pain usually do not rid the patient's back pain completely and are insufficient to prevent the fracture-weakened vertebral body from further fracturing with long term consequences for the biomechanical competence of the entire spine. In the last 10 years the minimal invasive treatment options vertebroplasty (VP) and balloon kyphoplasty (BK) have spread quickly because these procedures appeared to be promising treatments to stop the fracture and vertebral lesion associated back pain and to internally stabilize a fractured vertebral body. Numerous published reports on VP and BK appeared to support the notion of an immediate and lasting pain reduction after VP and BK in additon to a prevention of further fracturing of the treated vertebrae. The first three randomized controlled and partly blinded trials have been published this year. Two of these trials demonstrate that VP does not result in a better pain control than a sham operation whereas BK was shown to reduce back pain due to verterbal fractures for at least 12 months. Considering that more than 1.5 million people world-wide have been treated with VP and BK until now this work discusses the recent trials and suggests clinical and academic consequences on the basis of the most recent evidence.

Comparison of kyphoplasty with use of a calcium phosphate cement and non-operative therapy in patients with traumatic non-osteoporotic vertebral fractures.

One of the current standard treatment options for younger patients with stable traumatic vertebral fractures is conservative treatment using braces. Kyphoplasty as a minimally invasive procedure has been shown to be effective in stabilizing vertebral body fractures, resulting in immediate pain relief and improved physical function. The purpose of this prospective study was to clarify whether patients with acute traumatic vertebral fractures benefit more from kyphoplasty or from conservative treatment with a brace. A prospective study was undertaken in two centers. Forty patients with acute painful traumatic vertebral body fractures type A1-A3 (AO-classification) after adequate trauma, without osteoporosis, suitable for kyphoplasty or therapy by brace were included into the study. Follow-up was 12 months. Patients of the kyphoplasty group showed an immediate beneficial and significant effect postoperatively, and better outcomes 1 and 3 months after operation compared to the conservatively treated group in pain feeling, mobility and vertebral body height. After 12 months the difference between both groups was not significant excepting the vertebral body height. Kyphoplasty provides early and lasting reduction of pain and improvement of daily activity. However, there are clinically asymptomatic cement leakages in up to 45% of which we do not know the consequences in long term. Every patient with traumatic vertebral body fracture treated by kyphoplasty has to be informed about that. Long-time results are outstanding and our findings require confirmation by randomized controlled trials.

[Filling of metaphyseal defects with nanocrystalline hydroxyapatite (Ostim) for fractures of the radius]. / Verwendung von nanokristallinem Hydroxyapatit (Ostim) bei der Versorgung von Radiusfrakturen.

AIM OF THE STUDY: In this study, innovative bone replacement material was tested after complicated metaphyseal radius fractures with the affected joints. MATERIAL AND METHODS: In all, 11 C 2, 11 C 3 and 3 A 3 radius fractures were treated by surgery combining an angularly stable palmar plate osteosynthesis with defect filling using nanocrystalline hydroxyapatite. Examinations were conducted preoperatively and postoperatively after 4 weeks, 12 weeks and 9-12 months. RESULTS: After 10.5+/-1.4 months, inclination angles of 8.7+/-1.8 degrees (dorsopalmar) and 18.8+/-2.9 degrees (radioulnar) were measured at the treated fractures, the ulnar drift was 0.6+/-1.8 mm. According to the Gartland/Werley scale, 10 therapeutic results were considered "excellent", 12 "good" and 3 "fair". CONCLUSION: An angularly stable plate osteosynthesis with metaphyseal defect filling using nanocrystalline hydroxyapatite for the treatment of A 3, C 2 and C 3 radius fractures showed satisfactory radiological and clinical results.

[Kyphoplasty : method for minimally invasive treatment of painful vertebral fractures]. / Kyphoplastie : Minimal-invasives Verfahren zur Versorgung schmerzhafter Wirbelkörperfrakturen.

Painful osteoporotic and malignant vertebral fractures are frequent causes of chronic back pain with negative consequences regarding immobility, quality of life, morbidity, mortality, and fracture incidence. The best currently available evidence-based treatment reduces vertebral fracture risk but does not totally prevent follow-up fractures. Kyphoplasty is a causal treatment of pain by internal stabilization that prevents the ongoing pain of constant vertebral (micro-)fracture. The indication for this minimally invasive procedure requires interdisciplinary discussion of the individual case to guarantee technical feasibility, increase the likelihood that kyphoplasty will indeed reduce pain, and embed this procedure in the individual patient's long-term therapeutic concept or treatment of painful vertebral metastases. In addition to internal stabilization of painful vertebral fractures, kyphoplasty seeks to restore lost vertebral height, which appears promising in acute and painful vertebral fractures. Available controlled prospective studies demonstrate long-term patient benefits in terms of pain reduction, mobility, and improved quality of life.

[Indications and results of kypho- and vertebroplasty]. / Indikationen und Ergebnisse der Kypho- und Vertebroplastie.

The best currently available evidence based treatment reduces vertebral fracture risk but does not totally prevent osteoporotic and malignant follow-up fractures. Kyphoplasty and vertebroplasty are options of a causal treatment to reduce pain by internal stabilization of fractured vertebrae. The indication for these minimal invasive procedures requires an interdisciplinary discussion of the individual case to guarantee technical feasibility, to increase the likelihood that these procedures will indeed reduce pain and to embed these procedures into the long term therapeutic concept of every single patient. In addition to internal stabilization of a painfully fractured vertebra kyphoplasty also seeks to restore lost vertebral height which appears promising in acute vertebral fractures. Due to the procedure there are more cement leakages after vertebroplasty. Available controlled prospective studies demonstrate only for kyphoplasty a long-term benefit for the patient in terms of pain reduction, increased mobility and improved quality of life.

[In vitro studies on various PMMA bone cements: a first comparison of new materials for arthroplasty]. / In-vitro-Untersuchung unterschiedlicher PMMA-Knochenzemente--ein erster Vergleich neuer Materialien für die Endoprothetik.

AIM: Two clinically established PMMA bone cements (Refobacin Palacos R and Palacos R + G) and two newer cements not yet in widespread clinical use (Refobacin Bone Cement R and SmartSet GHV) were tested in vitro for practically relevant differences. METHODS: The tests included chemical analyses, handling properties and testing according to the ISO standard for PMMA bone cements. RESULTS: The results obtained indicate clearly that the copolymers used in Refobacin Bone Cement R and SmartSet GHV differ from those used in the Palacos cements. There were also significant differences in viscosity behaviour and waiting time (p < 0.01 for Palacos cements versus Refobacin Bone Cement R) as an expression of different handling properties. The hardening times under ISO 5833 conditions also differed significantly (p < 0.01 and p < 0.05 for Palacos cements compared with Refobacin Bone Cement R and p < 0.01 for Refobacin Bone Cement R compared with SmartSet GHV). CONCLUSION: In view of these differences in material properties, the clinical data from long-term use of the bone cements Refobacin Palacos R and Palacos R + G cannot be extrapolated to the newly developed PMMA cements Refobacin Bone Cement R and Smart GHV. Before broad clinical use of these cements, prospective clinical studies using RSA or DEXA and, as a second step, statistically powerful prospective comparative studies should be performed. Until these data are available, patients in whom Refobacin Bone Cement R and SmartSet GHV are used should be informed that the material employed deviates from the standard procedures for cemented joint replacement in the Scandinavian arthroplasty registers and that the long-term consequences cannot, in the final instance, be foreseen. This is essential in order to avoid later malpractice claims on the grounds of inadequate information.

[Balloon kyphoplasty in the therapy of vertebral fractures]. / Ballonkyphoplastie in der Therapie von Wirbelkörperfrakturen.

Approximately 500,000 vertebral fractures occur as a result of osteoporosis every year in Europe. One third of the patients thus affected complain of severe back pain and seek treatment. In the past, the treatment of such fractures was limited to conservative methods, such as the use of braces and analgesics and long-term immobilisation followed by physiotherapy. Since 1998 balloon kyphoplasty, a minimally invasive procedure, has also been available for their treatment. During balloon kyphoplasty a balloon system is introduced into a fractured vertebral body to achieve bitranspedicular augmentation, after which low-viscosity bone cement is injected into the vertebral body, where it sets very quickly. In general the patient can be fully mobilized 24-48 h after the procedure and in most cases the symptoms are then considerably attenuated; many patients are actually free of pain. Published studies and our own experience indicate that balloon kyphoplasty is a safe method of treating painful vertebral compression fractures sustained in various ways and that complications are rare with this procedure.

Problems and costs associated with alcohol and drug abuse in emergency medicine.

Preclinical care refers to patients with life-threatening conditions. It remains unclear how alcohol and drug abuse contribute to the frequency and severity of emergency cases. This study evaluated the influence of these psychotropic substances on preclinical emergencies and the social security costs arising from this. The records of 400 emergency patients were analyzed prospectively regarding type and severity of emergency, intake of psychotropic substances before the emergency, and their influence on patients' outcome. Psychotropics were detected in 19% of patients; 84% of these patients (vs. 55% overall) were scored below 4 (not life threatening) on the National Advisory Committee for Aeronautics scale and therefore did not require a physician on-site. Alcohol or drug intake frequently causes emergencies with physicians on-site; retrospectively 84% of these interventions were thus found to be unnecessary, caused by difficulties in recognizing the severity of the disorder, especially in mental or respiratory disorders. Extrapolated to Germany overall this means 675,000 drug-related emergencies yearly, costing euro 310,000,000.

Osseous integration of calcium phosphate in osteoporotic vertebral fractures after kyphoplasty: initial results from a clinical and experimental pilot study.

INTRODUCTION: This study evaluated the radiological changes at the bone-cement interface of calcium phosphate cement (CPC) and polymethylmethacrylate (PMMA) 12 months after kyphoplasty. In a pilot experiment, we additionally performed a histomorphometric analysis in osteopenic foxhounds to analyze the process of osseous integration of CPC and PMMA. METHODS: Twenty postmenopausal female patients with 46 vertebral compression fractures (VCF) were treated by kyphoplasty, utilizing CPC (N=28) or PMMA (N=18) for intravertebral stabilization. After a 12-month follow-up, we measured the density changes of border voxels at the bone-cement interface by computed tomography (CT) using dedicated software algorithms. We defined the border-voxel density (BVD) as a parameter of cement resorption at the interface. We also investigated the bone-implant interface in three osteopenic foxhounds by histomorphometry 3, 6, and 12 months after cement implantation. RESULTS: Twelve months after kyphoplasty, only CPC showed a significant decrease of the BVD compared to PMMA (p<0.01), indicating a slow progress of resorption at the interface. Histomorphometry of the dog vertebrae showed near total bone coverage of CPC implants, whereas the PMMA surface exhibited only 30% direct bone contact (p<0.01). We also observed a time-dependent increase in the number of discernable osteons close to the interface of CPC, but no bone tissue within PMMA (p<0.01). CONCLUSIONS: The decrease of the BVD 12 months after kyphoplasty may indicate osseous integration of CPC by: (1) the ingrowth of bone tissue and (2) osteonal penetration close to the interface.

[Balloon kyphoplasty in the treatment of back pain]. / Die Ballonkyphoplastie in der Behandlung des Rückenschmerzes.

BACKGROUND: Experience of just under 5 years has shown that balloon kyphoplasty can be just as successfully employed as the longer-stablished vertebroplasty for the treatment of back pain due to recent or prior osteoporotic fractures as well as new traumatic fractures. MATERIAL AND METHOD: Among 345 patients with a total of 690 treated vertebral bodies, the change in pain symptomatology was analyzed for a follow-up period of 12 months in 40 study patients who underwent kyphoplasty and a control group of 20 patients. In addition, the pain experienced by a further 29 patients with new traumatic vertebral body fractures was monitored over a 12-month period. These fractures were partly managed by fixateur interne alone and by a combination of fixateur interne and kyphoplasty. RESULTS: The 40 patients treated by kyphoplasty had a baseline VAS score of 26.2+/-2.00, which increased to 44.4+/-3.11 after 12 months, while the respective scores for the control group were 33.6+/-4.21 and 34.3+/-4.35. In the 29 patients with new traumatic vertebral body fractures, the initial VAS score was 62 and after 12 months a distinct reduction of pain was noted with a score of 20 (100 = maximum pain, 0 = no pain). The number of times that the 40 patients managed by kyphoplasty had to consult their general practitioner was significantly reduced by the pain therapy. CONCLUSION: Balloon kyphoplasty verifiably improved the pain symptomatology after vertebral fracture over a period of 12 months. Comparison with the control group, which received the same osteoporosis drug therapy, confirmed the effect of this minimally invasive treatment form.

[Balloon kyphoplasty in the treatment of vertebral fractures]. / Ballonkyphoplastie in der Therapie von Wirbelkörperfrakturen.

Approximately 500,000 vertebral fractures occur as a result of osteoporosis every year in Europe. One third of the patients thus affected complain of severe back pain and seek treatment. In the past, the treatment of such fractures was limited to conservative methods, such as the use of braces and analgesics and long-term immobilisation followed by physiotherapy. Since 1998 balloon kyphoplasty, a minimally invasive procedure, has also been available for their treatment. During balloon kyphoplasty a balloon system is introduced into the fractured vertebral body to achieve bitranspedicular augmentation, after which low-viscosity bone cement is injected into the vertebral body, where it sets very quickly. In general the patient can be fully mobilized 24-48 h after the procedure and in most cases the symptoms are then considerably attenuated; many patients are actually free of pain. Published studies and our own experience indicate that balloon kyphoplasty is a safe method of treating painful vertebral compression fractures sustained in various ways and that complications are rare with this procedure.

Open reduction and palmar plate-osteosynthesis in combination with a nanocrystalline hydroxyapatite spacer in the treatment of comminuted fractures of the distal radius.

In a prospective study, we used the nanocrystalline hydroxyapatite paste Ostim (Osartis, Obernburg, Germany) in combination with a palmar plate to treat comminuted radius fractures with a metaphyseal and articular component in order to examine the clinical use of Ostim as a bone substitute. Twenty-one patients with 22 radius fractures of AO types C2 and C3 were included in the study. The measurements, taken 10.2+/-1.3 months after the initial treatment, revealed a dorsopalmar tilt of 8.8+/-3.7 degrees , a radioulnar inclination of 18.8+/-2.8 degrees and an ulnar variance of 0.8+/-1.8mm. According to the Gartland and Werley evaluation, eight of the treated fractures attained an excellent, 11 a good and the remaining three a fair result. The study demonstrates that Ostim, in combination with angularly stable osteosynthesis, can be used as an acceptable bone substitute for the treatment of type C2 and C3 radial fractures.

Transarterial embolization of primary and secondary tumors of the skeletal system.

Percutaneous transcatheteral embolizations of primary and secondary bone tumors are important minimal invasive angiographic interventions of the skeletal system. In most of the cases embolization is performed for preoperative devascularization or as a palliative measure to treat tumor-associated pain or other tumor bulk symptoms. The transarterial embolization of primary and secondary tumors of the skeletal system has been developed to a safe and very effective method. Indications, techniques, results and complications of this minimal invasive interventional therapy for treatment of primary and secondary bone tumors are described and discussed and compared with the newer literature and our own results.

CT volumetry of intravertebral cement after kyphoplasty. Comparison of polymethylmethacrylate and calcium phosphate in a 12-month follow-up.

This study was intended to measure the volume of intravertebral cement after balloon kyphoplasty with high resolution computed tomography (CT) and dedicated software. Volume changes of biocompatible calcium phosphate cement (CPC) were detected during a follow-up of 12 months. Measurements were compared with a control group of patients treated with polymethylmethacrylate (PMMA). Twenty-three vertebrae (14 CPC, 9 PMMA) of 12 patients were examined with CT using an identical imaging protocol. Dedicated software was used to quantify intravertebral cement volume in subvoxel resolution by analyzing each cement implant with a density-weighted algorithm. The mean volume reduction of CPC was 0.08 ml after 12 months, which corresponds to an absorption rate of 2 vol%. However, the difference did not reach significance level (P>0.05). The mean error estimate was 0.005 ml, indicating excellent precision of the method. CT volumetry appears a precise tool for measurement of intravertebral cement volume. CT volumetry offers the possibility of in vivo measurement of CPC resorption.

Detection of high-energy phosphates in cortical bone as an indicator of bone healing and remodelling: use of a rabbit model.

UNLABELLED: PURPOSE; To study high-energy phosphates in cortical bone through experiments on inbred white New Zealand rabbits. METHODS: Tibial fractures were induced in 80 rabbits and then stabilised by screw osteosynthesis. After 3 (group A; n=40) or 7 days (groups B; n=40), the defective tissue was covered by local muscle flaps. At increasing intervals (from 1 to 16 weeks), the screws were removed and the animals were euthanised (n=8 per group). The bone was removed and analysed histomorphologically; adenosine triphosphate (ATP) levels were determined by high-performance liquid chromatography. RESULTS: The mean ATP concentration in healthy cortical bone at 16 weeks was 0.092 (standard error, 0.009) nmol/mg dry mass, which was significantly higher than that in the group with delayed healing: 0.081 (0.011) nmol/mg in group A and 0.005 (0.001) nmol/mg in group B (paired t test, p<0.05). Earlier healing led to lower rates of necrosis (0 vs 38; groups A vs B) and osteomyelitis. CONCLUSION: Early muscle-flap coverage can revascularise the cortical bone, which is reflected in the higher ATP content in the cortical bone measured by high-performance liquid chromatography. Measuring changes of ATP levels can help investigate the metabolism of the pathological bone.

[Evaluation of tibial torsion--comparison of clinical methods and computed tomography]. / Bestimmung der Tibiatorsion--Vergleich von klinischen Winkelmessungen zur Computertomographie.

PURPOSE: To determine variability between clinical goniometric methods and computed tomography (CT) in measuring posttraumatic malrotation of the tibia. MATERIALS AND METHODS: In a prospective study, absolute tibial torsion of both legs after unilateral fracture of the tibia as well as the difference between both legs (intra-individual torsional difference) was postoperatively determined with two goniometric and two CT methods in 40 patients (female : male = 16 : 24, mean age = 46 +/- 34 years). RESULTS: The mean difference between goniometric and CT methods in determining intra-individual torsional difference was not significant. Nevertheless, variance of values was higher in goniometric measurement (up to +/- 11 degree), with the measurements of torsional difference showing two times greater standard deviation in interobserver variability of goniometric methods as compared to CT. CONCLUSION: Goniometric methods do not significantly differ from the CT methods for determination of intraindividual torsional difference. The higher variance of interobserver values limits accuracy of goniometric methods. Therefore, goniometric determination of tibial torsion can only be considered an estimate but not a precise measurement.

[The evaluation of balloonkyphoplasty for osteoporotic vertebral fractures. An interdisciplinary concept]. / Die Wertigkeit der Ballonkyphoplastie bei der osteoporotischen Wirbelkörperfraktur. Ein interdisziplinäres Konzept.

BACKGROUND DATA: Patients with osteoporotic vertebral compression fractures frequently complain of pain and a loss of function and mobility. Such fractures are associated with an increased mortality. The common treatment with bed rest, bracing or osteosynthesis does not lead to satisfying results. With two new surgical techniques, vertebroplasty and kyphoplasty, an internal stabilisation of osteoporotic vertebral fractures is possible. METHODS: All patients were treated by kyphoplasty. With a minimal invasive dorsal approach, an inflatable bone tamp is placed in the fractured vertebral body. This tamp can restore the vertebral body height and create a cavity, which is filled with bone cement under low pressure. The advantage of kyphoplasty compared to vertebroplasty is the restoration of the vertebral height and a decreased cement leakage rate. We performed a prospective, interdisciplinary study with a follow-up of 12 months. We treated 192 vertebral fractures in 102 patients. Augmentation was performed with polymethylmethacrylate in 138 cases and with a new injectable calcium phosphate-cement in 54 vertebral bodies. Outcome data were obtained with two different spine-scores and by the radiomorphometric evaluation of x-rays before and after treatment. RESULTS: We noticed a significant improvement in pain and function in 89% of the patients. All patients showed a regain of vertebral height of on average 17%. In 7% of all treated vertebral bodies, we noticed cement leakage, which was, however, far below the rates published for vertebroplasty (20-70%). There were two complications, bleeding due to an unknown coagulopathy and a violation of the myelon by malpunction. CONCLUSION: Kyphoplasty is a reliable and minimally invasive method for stabilizing fractured osteoporotic vertebral bodies. Improvement of pain and function and a regain in height of the treated vertebral body can be accomplished.