Document Detail

Treatment of an osteoporotic vertebral compression fracture with the StaXx FX system resulting in intrathoracic wafers: a serious complication.
Jump to Full Text
MedLine Citation:
PMID:  22045199     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: To report a serious complication of the StaXx FX system used to stabilize an osteoporotic vertebral fracture.
CASE REPORT: A 76-year-old woman presented with a painful vertebral fracture. Treatment by means of a PEEK wafer kyphoplasty was complicated by malposition of the wafers. The patient recovered fully after removal of the wafers by means of a thoracotomy.
CONCLUSIONS: New treatment modalities have their own pitfalls and possible complications, as demonstrated in this case report. Caution regarding implementation of new treatment modalities should be practiced.
Authors:
L W van der Plaat; G H Bulstra; G H R Albers; J P Eerenberg; H M van der Vis
Related Documents :
22878969 - The hip antero-superior labral tear with avulsion of rectus femoris (haltar) lesion: do...
17151979 - A novel surgical technique for transverse sternal bone defects using flexible intramedu...
15722269 - Chondral defect repair after the microfracture procedure: a nonhuman primate model.
12054709 - Regeneration of defects in the articular cartilage in rabbit temporomandibular joints b...
1119989 - Cricoid arch replacement in dogs. further studies.
16842289 - Induction of a barrier membrane to facilitate reconstruction of massive segmental diaph...
19801289 - Effect of knee flexion angle on length and orientation of posterolateral femoral tunnel...
4091909 - Arthroscopic partial medial meniscectomy: an analysis of unsatisfactory results.
10726509 - The thickness of the skull in korean adults.
Publication Detail:
Type:  Journal Article     Date:  2011-11-02
Journal Detail:
Title:  European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society     Volume:  21 Suppl 4     ISSN:  1432-0932     ISO Abbreviation:  Eur Spine J     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-06-07     Completed Date:  2012-10-25     Revised Date:  2013-06-27    
Medline Journal Info:
Nlm Unique ID:  9301980     Medline TA:  Eur Spine J     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  S445-9     Citation Subset:  IM    
Affiliation:
Department of Orthopaedic Surgery, Academic Medical Center, Postbus 22660, 1100 DD, Amsterdam, The Netherlands. Lplaat@hotmail.com
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Aged
Female
Fractures, Compression / surgery*
Humans
Kyphoplasty / adverse effects*
Osteoporotic Fractures / surgery*
Pain / etiology,  surgery*
Spinal Fractures / surgery*
Thoracic Vertebrae / surgery*
Thoracotomy
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Full Text
Journal Information
Journal ID (nlm-ta): Eur Spine J
Journal ID (iso-abbrev): Eur Spine J
ISSN: 0940-6719
ISSN: 1432-0932
Publisher: Springer-Verlag, Berlin/Heidelberg
Article Information
Download PDF
© The Author(s) 2011
Received Day: 16 Month: 6 Year: 2011
Revision Received Day: 14 Month: 10 Year: 2011
Accepted Day: 15 Month: 10 Year: 2011
Electronic publication date: Day: 2 Month: 11 Year: 2011
pmc-release publication date: Day: 2 Month: 11 Year: 2011
Print publication date: Month: 6 Year: 2012
Volume: 21 Issue: Suppl 4
First Page: 445 Last Page: 449
ID: 3369049
PubMed Id: 22045199
Publisher Id: 2053
DOI: 10.1007/s00586-011-2053-6

Treatment of an osteoporotic vertebral compression fracture with the StaXx FX system resulting in intrathoracic wafers: a serious complication
L. W. van der Plaat1 Address: +31-20-566-9111 +31-20-566-4440 Lplaat@hotmail.com
G. H. Bulstra2
G. H. R. Albers3
J. P. Eerenberg4
H. M. van der Vis3
1Department of Orthopaedic Surgery, Academic Medical Center, Postbus 22660, 1100 DD Amsterdam, The Netherlands
2Department of Orthopaedic Surgery, Sint Lucas Andreas Hospital, Amsterdam, The Netherlands
3AVE Orthopaedic Clinics, Huizen, The Netherlands
4Department of General Surgery, Ter Gooi Hospital, Hilversum, The Netherlands

Introduction

The impact of osteoporotic vertebral compression fractures (VCF) on mortality [1] and quality of life [2] is increasingly acknowledged. Despite successful conservative treatment of the majority of patients [3], 37% of patients referred for an X-ray of the thoracic or lumbar spine by their general practitioner still experience pain after six months [4]. Vertebroplasty (VP), originally developed for treatment of vertebral angiomas [5] and kyphoplasty (KP) are now commonly accepted treatment options for VCFs.

Potentially serious complications (cement leakage leading to pulmonary emboli or neurological deficit) of VP and KP have been reported [68]. An alternative KP procedure uses sequentially inserted 1-mm thick polyetheretherketone (PEEK) wafers for controlled and vertically oriented kyphosis correction (StaXx FX system, Spine Wave, Inc, Shelton, USA). The theoretical advantages over other VP and KP procedures are retained fracture reduction, less cement leakage and restoration of the load-bearing properties of the intervertebral disc [9].

Complications can occur with all surgical procedures, but especially when they are serious and occur while using a new device lacking clinical results publication is warranted. We present a case report of a PEEK wafer KP resulting in anterolateral perforation of the vertebral body, necessitating a thoracotomy.


Case report

A 76-year-old, vital woman with a history of osteoporosis and a transient ischemic attack visited our outpatient clinic, with high back pain, interfering with daily activities. The pain occurred spontaneously 2 months earlier, and did not improve with acetaminophen and activity modification. On physical examination (59 kg, 1.58 m), compression pain over the spinal column and painful palpation of the spinous processes T6 and T7 was noted. Thoracic spine X-rays revealed an impression deformity of T7, with 15% anterior height loss (Fig. 1), AO type A1.2. MRI showed oedema, sign of a recent/active fracture. Due to failure of conservative therapy, the fracture was stabilized using a PEEK wafer KP.

After general anaesthesia and antibiotic prophylaxis (1,000 mg cefamandole) and prone positioning, a K-wire was inserted from a left extrapedicular entry position using fluoroscopy. After measuring the length, the sizer was inserted followed by gently tapping the wafer gun into the vertebra. The device penetrated the anterolateral cortex, and was withdrawn to the correct depth. During insertion of the first few wafers anterolateral protrusion was observed on fluoroscopy. Despite this observation, more wafers were introduced and these seemed to be positioned correctly. However, subsequent wafers again seemed to protrude (Fig. 2), therefore the procedure was terminated. Stabilization of the wafers by adding bone cement was omitted because of potential cement leakage into the thoracic cavity. The patient remained stable, and a direct postoperative X-ray revealed no pneumothorax, thus watchful waiting was performed after consulting a thoracic surgeon.

The thoracic spine X-ray performed the following day confirmed malposition of the wafers. The patient remained in good general condition, and was discharged from the hospital. The patient was prescribed acetaminophen with codeine 500/20 mg 4 times 2 daily and tramadol 50 mg 3 times 1 daily (VAS 4).

One week later she visited the emergency department with unbearable high back and right-sided thoracic pain (VAS 10), without dyspnoea. Tramadol had been replaced with Naproxen because of hallucinations. On physical examination, she was hemodynamically stable, without neurological deficit, but axial compression of the spinal column was painful. There were no signs of infection. Progressive displacement of one wafer was noted on the thoracic spine X-ray (Fig. 3). The anterior vertebral height loss had increased to 32%, probably due to the weakening of the vertebral body by the previous surgery. A CT-scan revealed protrusion of the wafers, in close proximity to the right pulmonary artery and stem bronchus, with fluid in the right pleural cavity (Fig. 4). After consultation with the thoracic surgeon, we decided to remove the wafers, and use an alternative method of stabilisation.

Following general anaesthesia and antibiotic prophylaxis (1,000 mg cefamandole) and left-sided positioning a right posterolateral thoracotomy was performed. By blocking ventilation the right lung collapsed. The wafers penetrated the parietal and visceral pleura (Fig. 5). The vagal nerve was stretched around the wafers, but intact. After removal of the wafers, the residual cavity in the vertebral body was probed and deemed circumferentially intact. It was filled with a resected piece of the sixth rib (Fig. 6). An intrathoracic suction drain and a subpleural analgesic catheter were inserted. The right lung was inflated and the thoracotomy closed with thick double stranded sutures followed by routine wound closure.

Postoperatively she went to the ICU, and was transferred to the orthopaedic ward the next day after a thoracic X-ray revealed absent residual pneumothorax. Within 2 days the excruciating pain subsided, although analgesics were required for thoracotomy wound pain. X-rays and a CT-scan showed proper positioning of the rib-graft in the vertebra (Fig. 7). Three days postoperation, atrial fibrillation developed and was successfully treated with digoxin. She was discharged in good health after 19 days with a 3-point extension spinal orthosis for 6 weeks.


Discussion

We present a serious complication of a PEEK wafer KP procedure in an osteoporotic VCF. Fortunately, the patient recovered extremely well. In addition to investigating characteristics of bone substitutes to decrease complications of VP and KP [1013], alternatives and modifications of VP and KP are currently emerging. These include lordoplasty [14], vesselplasty [15], vertebral body stenting [16], mesh-allograft-stenting [17], among others [18], as well as the StaXx FX system. In experimentally created VCFs, partial endplate reduction and kyphosis correction could be achieved with the StaXx FX system, with intervertebral disk pressure corrected to 86% of normal [9]. In addition, in 26 VCFs treated with the device, a significant decrease in visual analogue scale (VAS) pain score was observed after 8 months of follow-up [19]. No clinical reports comparing these alternatives of VP and KP to regular VP or KP or conservative treatment are available. Surgical treatment of VCFs unresponsive to conservative therapy (with VP or KP) remains controversial [2029]. In a subgroup of patients, VP appears to be superior to conservative treatment [30]. Unfortunately, at the moment it is not possible to identify these patients shortly after they sustain a VCF.

Regarding the complication described in this article, we think there are two possible explanations:

  1. Perforation of the vertebral cortex with the wafer gun, creating a hole through which the wafers could protrude (faulty surgical technique). Perhaps at this moment switching to another method of stabilisation (for instance posterior instrumentation) would have been preferred. A more gradual increase in diameter of the wafer gun possibly lowers resistance during insertion, which might reduce occurrence of this complication.
  2. A design flaw in the wafer gun allowing the wafers to progress beyond its anterior rim. Perhaps a higher anterior rim or different wafer shape would prevent this.

Incidence and prevalence of osteoporotic VCFs will increase. Heightened awareness of their impact on quality of life and mortality is changing our view of these fractures. Patients today are better informed and more assertive, in demanding (surgical) treatment. Nevertheless, we need to remain critical of new treatment modalities while their (long-term) results and complications are unknown. We feel it is important to describe complications occurring while using (new) surgical systems.


We would like to thank Mr. S. Westerbos, MD for his valuable contribution to this article. No funds or benefits have been or will be received for this manuscript.

Conflict of interest

None of the authors has any potential conflict of interest.

Open Access

This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.


References
1.. Ioannidis G,Papaioannou A,Hopman WM,Akhtar-Danesh N,Anastassiades T,Pickard L,Kennedy CC,Prior JC,Olszynski WP,Davison KS,Goltzman D,Thabane L,Gafni A,Papadimitropoulos EA,Brown JP,Josse RG,Hanley DA,Adachi JD. Relation between fractures and mortality: results from the Canadian multicentre osteoporosis studyCMAJYear: 2009181526527110.1503/cmaj.08172019654194
2.. Papaioannou A,Kennedy CC,Ioannidis G,Sawka A,Hopman WM,Pickard L,Brown JP,Josse RG,Kaiser S,Anastassiades T,Goltzman D,Papadimitropoulos M,Tenenhouse A,Prior JC,Olszynski WP,Adachi JD. The impact of incident fractures on health-related quality of life: 5 years of data from the Canadian multicentre osteoporosis studyOsteoporos IntYear: 200920570371410.1007/s00198-008-0743-718802659
3.. Papaioannou A,Watts NB,Kendler DL,Yuen CK,Adachi JD,Ferko N. Diagnosis and management of vertebral fractures in elderly adultsAm J MedYear: 2002113322022810.1016/S0002-9343(02)01190-712208381
4.. Klazen CA,Verhaar HJ,Lohle PN,Lampmann LE,Juttmann JR,Schoemaker MC,Everdingen KJ,Muller AF,Mali WP,Vries J. Clinical course of pain in acute osteoporotic vertebral compression fracturesJ Vasc Interv RadiolYear: 20102191405140910.1016/j.jvir.2010.05.01820800779
5.. Grados F,Depriester C,Cayrolle G,Hardy N,Deramond H,Fardellone P. Long-term observations of vertebral osteoporotic fractures treated by percutaneous vertebroplastyRheumatology (Oxford)Year: 200039121410141410.1093/rheumatology/39.12.141011136886
6.. Teng MM,Cheng H,Ho DM,Chang CY. Intraspinal leakage of bone cement after vertebroplasty: a report of 3 casesAm J NeuroradiolYear: 200627122422916418389
7.. Freitag M,Gottschalk A,Schuster M,Wenk W,Wiesner L,Standl TG. Pulmonary embolism caused by polymethylmethacrylate during percutaneous vertebroplasty in orthopaedic surgeryActa Anaesthesiol ScandYear: 200650224825110.1111/j.1399-6576.2005.00821.x16430551
8.. Monticelli F,Meyer HJ,Tutsch-Bauer E. Fatal pulmonary cement embolism following percutaneous vertebroplasty (PVP)Forensic Sci IntYear: 20051491353810.1016/j.forsciint.2004.06.01015734107
9.. Renner SM,Tsitsopoulos PP,Dimitriadis AT,Voronov LI,Havey RM,Carandang G,McIntosh B,Carson C,Ty D,Ringelstein JG,Patwardhan AG. Restoration of spinal alignment and disk mechanics following polyetheretherketone wafer kyphoplasty with StaXx FXAJNR Am J NeuroradiolYear: 20113271295130010.3174/ajnr.A248421680656
10.. Boger A,Heini P,Windolf M,Schneider E. Adjacent vertebral failure after vertebroplasty: a biomechanical study of low-modulus PMMA cementEur Spine JYear: 200716122118212510.1007/s00586-007-0473-017713795
11.. Boger A,Wheeler KD,Schenk B,Heini PF. Clinical investigations of polymethylmethacrylate cement viscosity during vertebroplasty and related in vitro measurementsEur Spine JYear: 20091891272127810.1007/s00586-009-1037-219479285
12.. Heini PF,Berlemann U. Bone substitutes in vertebroplastyEur Spine JYear: 200110S205S21310.1007/s00586000020411716020
13.. Heini PF,Berlemann U,Kaufmann M,Lippuner K,Fankhauser C,Landuyt P. Augmentation of mechanical properties in osteoporotic vertebral bones—a biomechanical investigation of vertebroplasty efficacy with different bone cementsEur Spine JYear: 200110216417110.1007/s00586000020411345639
14.. Orler R,Frauchiger LH,Lange U,Heini PF. Lordoplasty: report on early results with a new technique for the treatment of vertebral compression fractures to restore the lordosisEur Spine JYear: 200615121769177510.1007/s00586-006-0108-x16724212
15.. Flors L,Lonjedo E,Leiva-Salinas C,Marti-Bonmati L,Martinez-Rodrigo JJ,Lopez-Perez E,Figueres G,Raoli I. Vesselplasty: a new technical approach to treat symptomatic vertebral compression fracturesAm J RoentgenolYear: 2009193121822610.2214/AJR.08.150319542417
16.. Rotter R,Martin H,Fuerderer S,Gabl M,Roeder C,Heini P,Mittlmeier T. Vertebral body stenting: a new method for vertebral augmentation versus kyphoplastyEur Spine JYear: 201019691692310.1007/s00586-010-1341-x20191393
17.. Kerr SM,Liechty B,Patel R,Harrop JS. Percutaneous vertebral compression fracture management with polyethylene mesh-contained morcelized allograft boneCurr Rev Musculoskelet MedYear: 200812848710.1007/s12178-007-9010-319468877
18.. Liu JB,Tang XM,Xu NW,Bao HT. Preliminary results for the treatment of a pain-causing osteoporotic vertebral compression fracture with a sky bone expanderK J RadiolYear: 20089542042510.3348/kjr.2008.9.5.420
19.. Olan W. Structural kyphoplasty: a novel approach that is safe and effective for vertebral fracture repair with early results suggesting a lower subsequent fracture rateJ Neuro Interv SurgYear: 2009117710.1136/jnis.2009.000851l
20.. Buchbinder R,Osborne RH,Ebeling PR,Wark JD,Mitchell P,Wriedt C,Graves S,Staples MP,Murphy B. A randomized trial of vertebroplasty for painful osteoporotic vertebral fracturesN Engl J MedYear: 2009361655756810.1056/NEJMoa090042919657121
21.. Kallmes DF,Comstock BA,Heagerty PJ,Turner JA,Wilson DJ,Diamond TH,Edwards R,Gray LA,Stout L,Owen S,Hollingworth W,Ghdoke B,Annesley-Williams DJ,Ralston SH,Jarvik JG. A randomized trial of vertebroplasty for osteoporotic spinal fracturesN Engl J MedYear: 2009361656957910.1056/NEJMoa090056319657122
22.. Fisher CG,Vaccaro AR. The highest level of evidence in a high impact journal: is this the final verdict?SpineYear: 20103515E676E67710.1097/BRS.0b013e3181e41f8720592575
23.. Fisher CG,Vaccaro AR,Whang PG,Prasad SK,Angevine PD,Mulpuri K,Thomas KC,Patel AA. Evidence-based recommendations for spine surgerySpineYear: 20113614E897E90310.1097/BRS.0b013e31821c06d821642806
24.. Noonan P. Randomized vertebroplasty trials: bad news or sham news?Am J NeuroradiolYear: 200930101808180910.3174/ajnr.A187519815616
25.. Yi L, Jingping B, Gele J, Baoleri X, Taixiang W (2006) Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit. Cochrane Database Syst Rev (4):CD005079
26.. Rousing R,Hansen KL,Andersen MO,Jespersen SM,Thomsen K,Lauritsen JM. Twelve-months follow-up in forty-nine patients with acute/semiacute osteoporotic vertebral fractures treated conservatively or with percutaneous vertebroplasty: a clinical randomized studySpineYear: 201035547848210.1097/BRS.0b013e3181b71bd120190623
27.. Wardlaw D,Cummings SR,Meirhaeghe J,Bastian L,Tillman JB,Ranstam J,Eastell R,Shabe P,Talmadge K,Boonen S. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trialLancetYear: 200937396681016102410.1016/S0140-6736(09)60010-619246088
28.. Kallmes DF,Jarvik JG. Spinal augmentation research: FREE at last?LancetYear: 2009373966898298410.1016/S0140-6736(09)60014-319246087
29.. Longo UG,Denaro V. Spinal augmentation: what have we learnt?LancetYear: 20093739679194710.1016/S0140-6736(09)61065-519501742
30.. Klazen CA,Lohle PN,Vries J,Jansen FH,Tielbeek AV,Blonk MC,Venmans A,Rooij WJ,Schoemaker MC,Juttmann JR,Lo TH,Verhaar HJ,Graaf Y,Everdingen KJ,Muller AF,Elgersma OE,Halkema DR,Fransen H,Janssens X,Buskens E,Mali WP. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trialLancetYear: 201037697461085109210.1016/S0140-6736(10)60954-320701962

Figures

[Figure ID: Fig1]
Fig. 1 

Thoracic spine X-rays showing the T7 fracture



[Figure ID: Fig2]
Fig. 2 

Intra-operative fluoroscopy of malpositioned wafers



[Figure ID: Fig3]
Fig. 3 

X-ray of the thoracic spine showing progressive malposition of one of the wafers



[Figure ID: Fig4]
Fig. 4 

CT-scan transversal view showing the malpositioned wafers with close relation to the right pulmonary artery and right stem bronchus



[Figure ID: Fig5]
Fig. 5 

Intra-operative photo showing the protruding wafers



[Figure ID: Fig6]
Fig. 6 

Intra-operative photo showing the resected piece of rib before insertion in the vertebral body



[Figure ID: Fig7]
Fig. 7 

Postoperative CT-scan of the thoracic spine showing the position of the rib graft within the vertebral body



Article Categories:
  • Case Report

Keywords: Keywords Spine, Osteoporosis, Fracture, Kyphoplasty, StaXx FX.

Previous Document:  Long-term results of major upper extremity replantations.
Next Document:  Patients with adolescent idiopathic scoliosis of Lenke type-1 curve exhibit specific pedicle width p...