Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial.
BACKGROUND
Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures.


METHODS
Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466.


RESULTS
Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5·2 (95% CI -5·88 to -4·72) after vertebroplasty and -2·7 (-3·22 to -1·98) after conservative treatment, and between baseline and 1 year was -5·7 (-6·22 to -4·98) after vertebroplasty and -3·7 (-4·35 to -3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74-3·37, p<0·0001) at 1 month and 2·0 (1·13-2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported.


CONCLUSIONS
In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost.


BACKGROUND
ZonMw; COOK Medical.
Klazen
Caroline A H
CA
Radiology, St Elisabeth Ziekenhuis, Tilburg, Netherlands. cahklazen@hotmail.com
Lohle
Paul N M
PN
de Vries
Jolanda
J
Jansen
Frits H
FH
Tielbeek
Alexander V
AV
Blonk
Marion C
MC
Venmans
Alexander
A
van Rooij
Willem Jan J
WJ
Schoemaker
Marinus C
MC
Juttmann
Job R
JR
Lo
Tjoen H
TH
Verhaar
Harald J J
HJ
van der Graaf
Yolanda
Y
van Everdingen
Kaspar J
KJ
Muller
Alex F
AF
Elgersma
Otto E H
OE
Halkema
Dirk R
DR
Fransen
Hendrik
H
Janssens
Xavier
X
Buskens
Erik
E
Mali
Willem P Th M
WP
D000368:Aged; D000369:Aged, 80 and over; D001530:Belgium; D001843:Bone Cements / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D005260:Female; D050815:Fractures, Compression / Q000191:economics / Q000209:etiology / Q000601:surgery / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010024:Osteoporosis / Q000150:complications*; D010146:Pain / Q000209:etiology; D059408:Pain Management; D010147:Pain Measurement; D011446:Prospective Studies; D019057:Quality-Adjusted Life Years; D016103:Spinal Fractures / Q000191:economics / Q000209:etiology / Q000601:surgery / Q000628:therapy*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D054854:Vertebroplasty / Q000191:economics
D001843:Bone Cements