J. Hillmeier

Treatment of Painful Vertebral Fractures by Kyphoplasty in Patients With Primary Osteoporosis: A Prospective Nonrandomized Controlled Study

This study investigates the effects of kyphoplasty on pain and mobility in patients with osteoporosis and painful vertebral fractures compared with conventional medical management.

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.

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.

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.

Minimal invasive Reposition und innere Stabilisierung osteoporotischer Wirbelkörperfrakturen (Ballonikyphoplastie)

Zusammenfassung.Operationsziel:Wiederaufrichtung eines frakturierten Wirbelkörpers mit einem aufblasbaren Ballonsystem, das minimal invasiv über Stichinzisionen transpedikulär platziert wird. Der geschaffene Hohlraum wird nach Entfernung der Ballons mit Polymethylmetacrylat-(PMMA-)Zement aufgefüllt und somit von innen her stabilisiert.Indikationen:Osteoporotische Kompressionsfrakturen von Wirbelkörpern mit erhaltener Lamina dorsalis (Hinterwand).Durch Metastasen bedingte Osteolysen im Wirbelkörper.Primäre gutartige Wirbelkörpertumoren, z. B. Hämangiome. Traumatische Wirbelkörperkompressionsfrakturen mit intakter Hinterwand.Kontraindikationen:Instabile Wirbelkörperfrakturen mit zerstörter Hinterwand.Gerinnungsstörungen.Bandscheibenleiden mit radikulärer Symptomatik.Vollständig zusammengebrochene Wirbelkörper (Vertebra plana).Operationstechnik:In Bauchlagerung unter Bildwandlerkontrolle beidseitiges transpedikuläres Vorschieben einer Hohlnadel bis in das dorsale Drittel des Wirbelkörpers. Entfernen der Yamshidi-Nadeln und Einbringen beider Arbeitskanülen über vorgelegte Führungsdrähte. Mit einem Handbohrer wird über die Arbeitskanülen in der Wirbelkörperspongiosa ein Kanal für die Ballonkatheter geschaffen. Einbringen der Ballonkatheter; langsames Auffüllen mit Kontrastmittel. Ständige Druckkontrolle über Manometer. Lagekontrolle durch Bildwandler in beiden Ebenen. Nach Aufrichtung des Wirbelkörpers wird der Ballon entleert und entfernt. Auffüllung des Hohlraums mit Knochenzement. Kontrolle im seitlichen Strahlengang, um einen Zementaustritt in den Spinalkanal zu vermeiden. Nach Aushärten des Zements Entfernen der Arbeitskanülen und Hautnaht.Ergebnisse:In einer prospektiven Studie an 95 Patienten mit osteoporotischen Wirbelkörperfrakturen (165 behandelte Wirbelkörper) zeigt sich nach Kyphoplastie und PMMA- oder Calciumphosphat-Zementauffüllung eine deutliche Beschwerdebesserung bei 89% der Operierten. Eine Wiederaufrichtung der Wirbelkörper war im Mittel um 16% der behandelten Wirbel möglich. Ein Zementaustritt—ohne Komplikationen—fand sich bei 14 Wirbelkörpern (8%) und lag somit deutlich unter den publizierten Werten bei der Vertebroplastie mit 20–70% Leckage.Abstract.Objective:Restoration of height of a fractured vertebral body with an inflatable balloon system introduced transpedicularly into the vertebral body. The system creates a cavity that is filled with bone cement. This minimally invasive procedure creates an internal stabilization.Indications:Osteoporotic vertebral compression fractures with an intact posterior wall.Osteolytic metastases.Primary benign vertebral tumors such as hemangiomata. Traumatic compression fractures with an intact posterior wall.Contraindications:Unstable burst fractures involving the posterior wall.Coagulopathies.Disk herniation accompanied by radiculopathy.Compression of entire vertebral body (vertebra plana).Surgical Technique:In prone position and under fluoroscopic control transpedicular placement of Yamshidi needles into the posterior third of the vertebral body through stab incisions. Insertion of guide wires through these needles for proper placement of working cannulae. Drilling of a channel for insertion of the balloon system. Under fluoroscopy in two planes, pressure-controlled filling of the balloon with a contrast medium. Once the proper vertebral height has been obtained, removal of contrast medium and balloon and filling of the cavity with cement avoiding any leakage into the spinal canal. Once the cement has hardened, removal of working cannulae, skin closure.Results:In a prospective study of 95 patients (165 vertebral bodies) with osteoporotic fractures treated with PMMA cement or calcium phosphate filling, we observed a marked symptom reduction in 89%. The average restoration of height amounted to 16%. Cement leakage not leading to any complications occurred in 14 vertebral bodies (8%), a percentage far below published values of 20–70%.