AbstractObjectiveTo assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral ...body.DesignRandomised, double blind, sham controlled clinical trial.SettingFour community hospitals in the Netherlands, 2011-15.Participants180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89).InterventionsParticipants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group.Main outcome measuresMain outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months’ follow-up.ResultsThe mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval −0.53 to 0.94) at baseline, −0.43 (−1.17 to 0.31) at one day, −0.11 (−0.85 to 0.63) at one week, 0.41 (−0.33 to 1.15) at one month, 0.21 (−0.54 to 0.96) at three months, 0.39 (−0.37 to 1.15) at six months, and 0.45 (−0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months’ follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction.ConclusionsPercutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months’ follow-up among patients with acute osteoporotic vertebral compression fractures.Trial registrationClinicalTrials.gov NCT01200277.
Purpose
Osteoporotic vertebral compression fractures are treated conservatively or in selected cases with percutaneous vertebroplasty (PV). The purpose of this retrospective analysis is to determine ...predictive factors for a high visual analogue scale (VAS) pain score after conservative, sham or PV and is based on previously published randomized trials.
Methods
The VERTOS II compared conservative versus PV, and VERTOS IV compared sham versus PV treatment. The conservative group received pain medication. The sham and PV group received subcutaneous lidocaine/bupivacaine. In addition, the PV group received cementation, which was simulated in the sham group. Nineteen different predictors of high (≥ 5) versus low (< 5) VAS pain score at 12 months were investigated.
Results
20.7% of patients in the PV group demonstrated a VAS ≥ 5 at the 12-month, compared to 40.1% in the conservative or sham group, with a significant difference (
χ
2
(1) = 15.26,
p
< 0.0001, OR = 2.57, 95% CI = 1.59 to 4.15). In the subgroup analysis, we detected five predictors for the risk of high pain scores (VAS ≥ 5 after 12 months follow-up), namely: female, baseline VAS > 8, long-term baseline pain, mild/severe Genant and new fractures.
Conclusions
Statistically significant more patients had a high pain score at 12 months in the sham and conservative group when compared with the PV group. Five predictors were identified for sustained high local back pain, regardless of the received treatment. Patients with moderate fracture deformity were less likely to have high pain scores at 12 months if they received PV than if they had sham or conservative therapy.
Background
Percutaneous vertebroplasty (PV) is an alternative option to treat pain after an osteoporotic vertebral compression fracture (OVCF). Controversy exists as to whether PV increases the risk ...of new OVCFs or prevents further vertebral height loss in treated levels. We assessed both during 1-year follow-up in patients with acute OVCF randomised to PV or a sham procedure.
Methods
VERTOS IV is a prospective, multicentre, randomised controlled trial comparing PV with sham therapy in 180 patients. New OVCFs and further vertebral height loss were assessed at 3, 6, and 12 months.
Results
After a median follow-up of 12 months (interquartile range (IQR) = 12–12) 31 new fractures were reported in 15 patients from the PV group and 28 new fractures in 19 patients from the sham group. The occurrence of new vertebral fractures did not significantly differ between the groups (
χ
2
(1) = 0.83,
p
= 0.36, OR = .71, 95%CI = 0.33–1.50). There was no higher fracture risk of adjacent versus distant vertebrae. After sham procedure, further height loss of treated vertebrae occurred more frequently (7 patients (8%) in the PV group and 39 (45%) in the sham group (
χ
2
(1) = 28.85,
p
< 0.001, OR = 9.84, 95%CI = 4.08–23.73)) and was more severe (
p
< .001) than after PV.
Conclusions
The risk of further vertebral height loss is significantly lower after PV compared to a sham intervention, i.e. PV protects against progressive vertebral height loss. In addition, PV does not increase the risk of new adjacent and distant OVCFs.
Level of Evidence
Level 1a, therapeutic study.
ClinicalTrials.gov number, NCT01200277
Objective: The optimal timing for discontinuation of clopidogrel before surgery remains under debate. The purpose of this study is to determine the effect of preoperative clopidogrel administration ...on postoperative blood loss and the total requirements of homologous blood products after coronary artery bypass grafting (CABG). We also evaluated the perioperative complications. Methods: Consecutive patients (n = 130) undergoing elective CABG were recruited and randomised between 2006 and 2007. In 38 patients (group 1), treatment with clopidogrel was discontinued 5 days prior to surgery, in 40 patients (group 2) 3 days before surgery and in 40 other patients (group 3) clopidogrel was stopped on the day of surgery. Results: Significantly more postoperative blood loss was observed in group 3 compared to group 1 (929 ± 472 ml vs 664 ± 312 ml; p = 0.009). Other group comparisons were not significant. Blood loss after 12 h and at drain removal was also significantly higher in group 3. Patients in group 3 also had higher total requirements of homologous blood products (p = 0.046) and a significantly higher need for fresh frozen plasma (FFP) transfusion (p = 0.034). Univariable regression analyses revealed that continuing clopidogrel till the day of surgery (group 3) was predictive for postoperative blood loss (β = 0.289; p = 0.007) and the total requirements of homologous blood products after surgery (β = 0.280; p = 0.008). These effects remained the same in multivariable analyses. Conclusions: Continuation of clopidogrel until the day of surgery induces significantly more postoperative blood loss and increases significantly the total requirements of homologous blood products and FFP transfusion after surgery. The blood loss and the use of blood products in the group that stopped at 3 days preoperatively were similar to that of the group that stopped at 5 days preoperatively.
Spastic ataxias are rare neurogenetic disorders involving spinocerebellar and pyramidal tracts. Many genes are involved. Among them,
CAPN1
, when mutated, is responsible for a complex inherited form ...of spastic paraplegia (SPG76). We report the largest published series of 21 novel patients with nine new
CAPN1
disease-causing variants and their clinical characteristics from two European university hospitals (Paris and Stockholm). After a formal clinical examination, causative variants were identified by next-generation sequencing and confirmed by Sanger sequencing.
CAPN1
variants are a rare cause (~ 1.4%) of young-adult-onset spastic ataxia; however, together with all published cases, they allowed us to better describe the clinical and genetic spectra of this form. Truncating variants are the most frequent, and missense variants lead to earlier age at onset in favor of an additional deleterious effect. Cerebellar ataxia with cerebellar atrophy, dysarthria and lower limb weakness are often associated with spasticity. We also suggest that cognitive impairment and depression should be assessed specifically in the follow-up of SPG76 cases.
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