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A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures
Oleh:
Kallmes, David F.
;
Comstock, Bryan A.
;
Heagerty, Patrick J.
;
Turner, Judith A.
Jenis:
Article from Journal - ilmiah internasional
Dalam koleksi:
The New England Journal of Medicine (keterangan: ada di Proquest) vol. 361 no. 06 (Aug. 2009)
,
page 569-579 .
Topik:
Vertebroplasty
;
Osteoporotic Spinal Fractures
Ketersediaan
Perpustakaan FK
Nomor Panggil:
N08.K.2009.04
Non-tandon:
1 (dapat dipinjam: 0)
Tandon:
tidak ada
Lihat Detail Induk
Isi artikel
Background : Vertebroplasty is commonly used to treat painful, osteoporotic vertebral compression fractures. Methods : In this multicenter trial, we randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland–Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients' ratings of average pain intensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month. Results : All patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in either the RDQ score (difference, 0.7; 95% confidence interval [CI], –1.3 to 2.8; P=0.49) or the pain rating (difference, 0.7; 95% CI, –0.3 to 1.7; P=0.19). Both groups had immediate improvement in disability and pain scores after the intervention. Although the two groups did not differ significantly on any secondary outcome measure at 1 month, there was a trend toward a higher rate of clinically meaningful improvement in pain (a 30% decrease from baseline) in the vertebroplasty group (64% vs. 48%, P=0.06). At 3 months, there was a higher crossover rate in the control group than in the vertebroplasty group (43% vs. 12%, P<0.001). There was one serious adverse event in each group. Conclusions : Improvements in pain and pain-related disability associated with osteoporotic compression fractures in patients treated with vertebroplasty were similar to the improvements in a control group.
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