Primary studies included in this systematic review

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Primary study

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Twelve-months follow-up in forty-nine patients with acute/semiacute osteoporotic vertebral fractures treated conservatively or with percutaneous vertebroplasty: A clinical randomized study

Journal Spine
Year 2010
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Study Design: Clinical randomized study. Objective: Percutaneous vertebroplasty is compared to conservative treatment in patients with acute or subacute osteoporotic vertebral fractures with respect to pain, physical and mental outcomes. The risk of vertebral fractures adjacent to treated levels is assessed. Summary of Background Data: There are some disagreements of the benefits of PVP for the treatment of acute osteoporotic vertebral fractures, but the long-term clinical outcome of PVP compared to conservative treatment has not been evaluated in a randomized study. Methods: The 3-months follow-up of this study has been published previously, and here we report the completed 12-months analysis. About 50 patients (41 females) were included from January 2001 until January 2008. Patients with vertebral fractures less than 8 weeks old were included and randomized to either PVP or conservative treatment. Pain was assessed with a visual analogue scale. Physical and mental outcomes were assessed by validated questionnaires and tests. Tests, questionnaires, and plain radiographs were performed at the inclusion and after 3 and 12 months. Results: Pain score before and after the operation in the PVP group was 7.9 and 2.0, respectively. There was no difference between the groups concerning pain at the 3- and 12-months follow-up. Supplementary assessment of back pain 1 month after discharge from hospital showed a significant lower VAS score in the PVP group over the conservative group. In the study period, 2 adjacent fractures in the PVP group and no adjacent fractures in the conservative group were registered. Conclusion: PVP is a good treatment for some patients with acute/subacute painful osteoporotic vertebral fractures, but the majority of fractures will heal after 8 to 12 weeks of conservative treatment with subsequent decline in pain. The risk of new fractures needs further research. © 2010, Lippincott Williams & Wilkins.

Primary study

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Balloon kyphoplasty versus vertebroplasty for treatment of osteoporotic vertebral compression fracture: A prospective, comparative, and randomized clinical study

Authors Liu JT , Liao WJ , Tan WC , Lee JK , Liu CH , Chen YH , Lin TB
Journal Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA
Year 2010
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Bone pain and spinal axial deformity are major concerns in aged patients suffering from osteoporotic vertebral compression fracture (VCF). Pain can be relieved by vertebroplasty or kyphoplasty procedures, in which the compressed vertebral body is filled with substitutes. We randomly assigned 100 patients with osteoporotic compression fracture at the thoraco-lumbar (T-L) junction into two groups: vertebroplasty and kyphoplasty; we used polymethylmethacrylate (PMMA) as the bone filler. Pain before and after treatment was assessed with visual analog scale (VAS) scores and vertebral body height and kyphotic wedge angle were measured from reconstructed computed tomography images. More PMMA was used in the kyphoplasty group than in the vertebroplasty group (5.56±0.62 vs. 4.91±0.65 mL, p<0.001). Vertebral body height and kyphotic wedge angle of the T-L spine were also improved (p<0.001). VAS pain scores did not differ significantly between the treatment groups. The duration of follow-up was 6 months. Two patients in the kyphoplasty group had an adjacent segment fracture. In terms of clinical outcome there was little difference between the treatment groups. Thus, owing to the higher cost of the kyphotic balloon procedure, we recommend vertebroplasty over kyphoplasty for the treatment of osteoporotic VCFs. Introduction: Spinal axial deformities are major concerns in aged patients suffering from osteoporotic vertebral compression fracture. Pain may be relieved by vertebroplasty or kyphoplasty. We investigated the radiological and clinical outcomes of these procedures. Methods: One hundred cases of VCF at the thoraco-lumbar junction were randomly assigned into two groups: vertebroplasty or kyphoplasty (50 cases each). We used polymethylmethacrylate as the bone filler. Pain before and after treatment was assessed with visual analog scale scores and vertebral body height and kyphotic wedge angle were measured from reconstructed computed tomography images. Results: More PMMA was used in the kyphoplasty group than in the vertebroplasty group (5.56±0.62 vs. 4.91±0.65 mL, p<0.001). Vertebral body height and kyphotic wedge angle of the T-L spine were also improved (p<0.001). VAS pain scores did not differ significantly between the treatment groups. The duration of follow-up was 6 months. Two patients in the kyphoplasty group had an adjacent segment fracture. Conclusions: In terms of clinical outcome there was little difference between the treatment groups. Thus, with the higher cost of the kyphotic balloon procedure, we recommend vertebroplasty over kyphoplasty for the treatment of osteoporotic VCFs. © 2009 International Osteoporosis Foundation and National Osteoporosis Foundation.

Primary study

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A randomized trial of vertebroplasty for osteoporotic spinal fractures

Journal The New England journal of medicine
Year 2009
Links Pubmed DOI PubMed Central
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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. (ClinicalTrials.gov number, NCT00068822.) Copyright © 2009 Massachusetts Medical Society.

Primary study

Unclassified

A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures

Journal The New England journal of medicine
Year 2009
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BACKGROUND: Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use. METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (<6 weeks or ≥6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months. RESULTS: A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (±SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6±2.9 and 1.9±3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, -0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period. CONCLUSIONS: We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.) Copyright © 2009 Massachusetts Medical Society.

Primary study

Unclassified

Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study.

Journal AJNR. American journal of neuroradiology
Year 2007
Links Pubmed PubMed Central
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PURPOSE: To prospectively assess the short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures (VCF) treated with percutaneous vertebroplasty (PV) compared with optimal pain medication (OPM). METHODS: Randomization of patients in 2 groups: treatment by PV or OPM. After 2 weeks, patients from the OPM arm could change therapy to PV. Patients were evaluated 1 day and 2 weeks after treatment. Visual analog score (VAS) for pain and analgesic use were assessed before, and 1 day and 2 weeks after start of treatment. Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Roland-Morris Disability (RMD) questionnaire scores were assessed before and 2 weeks after start of treatment. Follow-up scores in patients requesting PV treatment after 2 weeks OPM treatment were compared with scores during their OPM period. RESULTS: Eighteen patients treated with PV compared with 16 patients treated with OPM had significantly better VAS and used less analgesics 1 day after treatment. Two weeks after treatment, the mean VAS was less but not significantly different in patients treated with OPM, whereas these patients used significantly less analgesics and had better QUALEFFO and RMD scores. Scores in the PV arm were influenced by occurrence of new VCF in 2 patients. After 2 weeks OPM, 14 patients requested PV treatment. All scores, 1 day and 2 weeks after PV, were significantly better compared with scores during conservative treatment. CONCLUSION: Pain relief and improvement of mobility, function, and stature after PV is immediate and significantly better in the short term compared with OPM treatment.