P. J. Meeder

Reduction of pain and fracture incidence after kyphoplasty: 1-year outcomes of a prospective controlled trial of patients with primary osteoporosis

Previously, we reported significantly reduced pain and improved mobility persisting for 6 months after kyphoplasty of chronically painful osteoporotic vertebral fractures in the first prospective controlled trial. Since improvement of spinal biomechanics by restoration of vertebral morphology may affect the incidence of fracture, long-term clinical benefit and thereby cost-effectiveness, here we extend our previous work to assess occurrence of new vertebral fractures and clinical parameters 1 year after kyphoplasty compared with a conservatively treated control group. Sixty patients with osteoporotic vertebral fractures due to primary osteoporosis were included: 40 patients were treated with kyphoplasty, 20 served as controls. All patients received standard medical treatment. Morphological characteristics, new vertebral fractures, pain (visual analog scale), physical function [European Vertebral Osteoporosis Study (EVOS) score] (range 0–100 each) and back-pain-related doctors’ visits were re-assessed 12 months after kyphoplasty. There were significantly fewer patients with new vertebral fractures of the thoracic and lumbar spine, after 12-months, in the kyphoplasty group than in the control group (P=0.0084). Pain scores improved from 26.2 to 44.4 in the kyphoplasty group and changed from 33.6 to 34.3 in the control group (P=0.008). Kyphoplasty treated patients required a mean of 5.3 back-pain-related doctors’ visits per patient compared with 11.6 in the control group during 12 months follow-up (P=0.006). Kyphoplasty as an addition to medical treatment and when performed in appropriately selected patients by an interdisciplinary team persistently improves pain and reduces occurrence of new vertebral fractures and healthcare utilization for at least 12 months in individuals with primary osteoporosis.

Calcium-phosphate and polymethylmethacrylate cement in long-term outcome after kyphoplasty of painful osteoporotic vertebral fractures.

Study Design. A comparative prospective trial evaluating 3-year outcome. Objective. To compare clinical and morphologic outcomes as well as follow-up fractures after kyphoplasty of painful osteoporotic vertebral fractures with calcium-phosphate (CaP) cement (group 1) and with polymethylmethacrylate (PMMA)-cement (group 2). Summary of Background Data. CaP cements seem to be an alternative material for usage in kyphoplasty of vertebral fractures. CaP cements are biodegradable and replaceable by newly formed bone after implantation. Concerns have been raised with regard to the stability of resorbable CaP-cements after implantation into vertebrae post kyphoplasty. Calcibon is a possible CaP cement, which exhibited adequate stability in short-term observations. Materials and Methods. Kyphoplasty was performed in 40 consecutive patients with primary osteoporosis and painful vertebral fractures, 20 received CaP-cement, 20 were treated with PMMA-cement. All patients received a pharmacological antiosteoporosis treatment (1000 mg calcium, 1000 IU vitamin D3, and oral aminobisphosphonate), pain medication, and physiotherapy. Pain (visual analog scale [VAS]; range, 0–100), mobility (EVOS-score; range, 0–100) and radiomorphologic measurements were assessed at baseline and after 6, 12, and 36 months. Results. There were no statistically significant differences between the CaP and PMMA-cement group regarding VAS-scores, EVOS-scores, or height-restoration at any time point. Furthermore, there was no significant difference in the occurrence of vertebral follow-up fractures between both groups during the 3-year follow-up period. Conclusion. CaP cement, e.g., Calcibon, is as effective and safe as conventional PMMA-cement with regard to immediate and sustained pain reduction and improvement of mobility after kyphoplasty of patients with painful osteoporotic vertebral fractures. CaP cement has the potential of being resorbed and replaced by newly formed bone tissue; thus, it seems to be a promising alternative for PMMA also in younger patients with painful vertebral fractures.

The intravertebral vacuum phenomen as specific sign of osteonecrosis in vertebral compression fractures: results from a radiological and histological study

This study investigated the prevalence of the intravertebral vacuum phenomenon (IVP) and osteonecroses in vertebral compression fractures (VCFs). We therefore performed an histological analysis of biopsies obtained from VCFs prior to balloon kyphoplasty. Computed tomography (CT) scans were reviewed regarding the presence of an IVP (i.e. cleft sign, Kümmell disease). We reviewed the data of 266 consecutive patients treated by balloon kyphoplasty in 501 procedures from 2002 to 2004. From 180 patients (68%) we obtained adequate bone tissue for histological evaluation. Biopsy specimens were analysed regarding the presence of osteoporosis, infection, malignancy and osteonecrosis. CT scans of all 180 patients were reviewed for presence of an IVP. Histological examination revealed 135 (75%) osteoporoses, 20 (11%) neoplasms, 12 (7%) trauma cases and 13 (7%) osteonecroses. An IVP was present in 12 (7%) patients. There was a significant association of osteonecrosis and IVP (P < 0.0001). Eleven of 12 patients with a vacuum phenomenon showed an osteonecrosis on histology, wheras 11 of 13 patients with osteonecrosis showed an IVP on CT. The IVP is a specific sign of osteonecrosis in vertebral compression fractures (sensitivity 85%, specificity 99%, positive predictive value 91%). Our findings strongly support the thesis that an IVP indicates local bone ischemia associated with a non-healing vertebral collapse and pseudarthrosis.

Augmentation von Wirbelkörperfrakturen mit einem neuen Calciumphosphat-Zement nach Ballon-Kyphoplastie

ZusammenfassungFragestellungSind Schmerzreduktion und Funktionsverbesserung bei Kyphoplastie unter Verwendung des nicht toxischen Calcibon ebenso gut wie mit Polymethylmethacrylat (PMMA)?Patienten und MethodeIn einer prospektiven interdisziplinären Monocenterstudie wurden 99 Patienten (173 Wirbelkörper, „WK“) mit osteoporotischen und traumabedingten Frakturen von 12/2001–3/2003 mit Kyphoplastie behandelt. Bei 66 Patienten (127 WK) führten wir die Augmentation mit PMMA , bei 33 (46 WK) mit Calcibon durch. Nachuntersucht wurde klinisch mit einem VAS-Schmerz- und Funktionsscore und radiomorphometrisch mit Nativ-Röntgen und CT.ErgebnisseSchmerz und Funktion besserten sich bei 87% der Patienten—bei einer durchschnittlichen Aufrichtung der mittleren WK-Höhe von 16%. Die Zementaustrittsrate lag bei Verwendung von PMMA bei 9% und bei Calcibon mit modifizierter Injektionstechnik bei 10%. Schmerz, Funktion und Radiomorphometrie zeigten in der 6-Monats-Kontrolle keine signifikanten Unterschiede.FazitDie Kyphoplastie ist ein zuverlässiges und sicheres minimal-invasives Verfahren zur Stabilisierung frakturierter WK. Nach Augmentation mit Calcibon wird eine gute Schmerzreduktion, Funktionsverbesserung und Aufrichtung der behandelten WK erzielt.AbstractQuestionCan the same levels of pain reduction and increase in function be achieved in kyphoplasty procedures with Calcibon as with polymethylmethacrylate (PMMA) cement?Patients and methodsIn a prospective, interdisciplinary single-center study, 99 patients (173 vertebral fractures) were treated with kyphoplasty. Augmentation was performed with PMMA in 66 cases (127 vertebral bodies) and with Calcibon in 33 patients (46 vertebral bodies). Outcome data were obtained with a VAS spine score and by radiomorphometric evaluation of X-rays before and after treatment.ResultsPain and function improved in 87% of the patients; an average of 16% of the lost vertebral height was regained. A 9% cement leakage rate was observed with PMMA and 10% with Calcibon. There was no significant difference in pain reduction and radiomorphometric evaluation between the two techniques.ConclusionKyphoplasty is a reliable, minimally invasive method to stabilize fractured vertebral bodies. Augmentation with Calcibon improves pain and function and enables the treated vertebral body to regain of height.

Ultrasound Measurements at the Proximal Phalanges in Healthy Women and Patients with Hip Fractures

Abstract: Measurements of bone mineral density (BMD) are useful for the assessment of fracture risk in osteoporosis. First prospective studies showed that quantitative ultrasound as measured at the calcaneus also predicts future hip fracture risk, independently of BMD and as accurately as BMD. The aim of this study was to compile a reference population for a new ultrasound device that determines amplitude-dependent speed of sound (AD-SOS) through the proximal phalanges of the hand and to prove its ability to distinguish between health volunteers and osteoporotic patients. In a case–control study we examined 139 healthy women aged 21–94 years and a group of 24 female patients aged 69–94 years with recent hip fractures. In the healthy reference population additional BMD measurements were performed with dual-energy X-ray absorptiometry (DXA) and quantitative ultrasound measurements at the calcaneus were carried out. In vivo precision of AD-SOS measurements through the phalanges was 0.52% CV. Simple regression analyses showed a negative correlation with age (r= 70.73, p50.001); modest significant correlations with BMD of the lumbar spine (r= 0.36, p50.001) and BMD of the femoral neck (r= 0.37, p= 0.002) as measured with DXA were shown. The comparison with another ultrasound device measuring SOS and broadband ultrasound attenuation (BUA) through the calcaneus showed correlation with SOS (r= 0.50, p50.001); no significant correlation was found with BUA measurements. Furthermore a dependency of AD-SOS values in anthropometric factors such as body mass index (r= 0.37, p50.001), height (r= 0.40, p50.001) and weight (r= 0.23, p50.05) was shown. First study results on 24 clinically diagnosed osteoporotic patients, defined as patients with recent (51 week) pertrochanteric or femoral neck fractures, showed a good separation between age- and sex-matched controls and osteoporotic patients (Z= 72.0 SD). Receiver operating characteristic (ROC) curves showed an area under the fitted curve of 0.83 + 0.06. These results are powerful for a device measuring AD-SOS through the proximal phalanges of the hand, and further prospective studies have proven the capability of phalangeal ultrasound in fracture risk assessment.

Three-year Outcomes after Kyphoplasty in Patients with Osteoporosis with Painful Vertebral Fractures

PURPOSE Kyphoplasty immediately improves pain and mobility in patients with painful osteoporotic vertebral fractures, but long-term clinical outcomes are still unclear. This controlled trial evaluates pain, mobility and fracture incidence 3 years after kyphoplasty. MATERIALS AND METHODS Kyphoplasty was performed in 40 patients with painful osteoporotic vertebral fractures; 20 patients who were selected for kyphoplasty but chose not to undergo the procedure served as controls. All patients received pharmacologic antiosteoporosis treatment, pain medication, and physiotherapy. Pain (visual analog scale of 0-100), mobility (European Vertebral Osteoporosis Study questionnaire score of 0-100), and incident vertebral fractures were assessed at baseline, postprocedurally, and after 12 and 36 months. RESULTS Pain score improved after kyphoplasty from 73.8 to 55.9 (immediately after kyphoplasty), 55.6 (12 months), and 54.0 (36 months; P < .001). Pain score in the control group changed from 66.4 to 65.7 at 12 months and 64.0 at 36 months (P = .521). The pain score of the kyphoplasty group was significantly improved versus controls after 36 months (P = .023). Mobility score improved after kyphoplasty from 43.8 to 54.2 (immediately after kyphoplasty), 54.5 (12 months), and 54.8 (36 months; P = .0008) and remained increased (P = .308) compared with controls (39.8 immediately after kyphoplasty, 44.3 at 12 months, and 43.6 at 36 months). The incidence of new vertebral fractures after kyphoplasty was significantly reduced versus controls after 3 years (P = .0341). CONCLUSIONS Kyphoplasty reduces pain and improves mobility as long as 3 years after the procedure. The long-term risk of new vertebral fractures after kyphoplasty of chronically painful vertebral fractures is reduced versus controls.

Kyphoplastie und Vertebroplastie bei Frakturen im hohen Lebensalter

ZusammenfassungDie beiden minimalinvasiven perkutanen Techniken der Zementauffüllung osteoporotischer Wirbelkörperfrakturen—Vertebroplastie und Kyphoplastie mit Instillation von Polymethylmetacrylat (PMMA)—werden als „ultima ratio“ des therapeutischen Regimes von frakturbedingten Komplikationen der Osteoporose im Brust- und Lendenwirbelsäulenbereich vorgenommen. Bei der Vertebroplastie erfolgt die Zementapplikation mono- oder bipedikulär unter hohem Druck über eine Punktionsnadel. Optimalerweise durchdringt der Zement den Wirbelkörper als Ganzes und respektiert dabei die Hinterkante als Barriere gegen einen Zementaustritt nach dorsal. Eine Aufrichtung komprimierter Wirbelkörper erfolgt nicht. Bei der Kyphoplastie instilliert man den PMMA-Zement in zuvor durch aufblasbare Ballons transpedikulär beidseits geschaffene Hohlräume über Arbeitstrokare unter geringem Druck, die Möglichkeit einer Wiederherstellung der ursprünglichen Wirbelkörperhöhe ist damit gegeben. Die Gefahr eines unerwünschten Zementaustrittes ist minimiert.AbstractKyphoplasty and vertebroplasty are two minimally invasive percutaneous techniques used for treatment of osteoporotic vertebral compression fractures in the thoracic and lumbar spine. The injection of polymethylmetacrylate (PMMA) is often a final attempt at therapeutic treatment of complications due to such fractures. Vertebroplasty involves injection of cement via one or both pedicles under high pressure, thus filling and stabilizing the vertebra without reduction of fracture. Extravertebral cement leakage is a common complication: an intact posterior wall normally prevents cement leakage into the epidural space. Kyphoplasty involves transpedicular inflation of balloon tamps, thus creating a cavity which is then filled with PMMA under low pressure. Restoration of vertebral height is possible and the potential for extravertebral cement leakage lessened.

Kyphoplasty in patients with multiple myeloma a retrospective comparative pilot study

This retrospective study of 73 myeloma patients with painful vertebral lesions compares clinical and radiomorphological outcomes up to 2 years after additional kyphoplasty, radiation therapy or systemic treatment only.

[Kyphoplasty : method for minimally invasive treatment of painful vertebral fractures].

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 patients 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.

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 patients 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.