| 1. |
- Boonen, Steven, et al.
(författare)
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Balloon Kyphoplasty for the Treatment of Acute Vertebral Compression Fractures: 2-Year Results From a Randomized Trial
- 2011
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Ingår i: Journal of Bone and Mineral Research. - : Wiley. - 1523-4681 .- 0884-0431. ; 26:7, s. 1627-1637
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Tidskriftsartikel (refereegranskat)abstract
- Vertebral fractures are often painful and lead to reduced quality of life and disability. We compared the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p = .003) but not at 12 months (1.70 points, 95% CI -0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI -0.63 to 3.99, p = .15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect -1.49 points, 95% CI -1.88 to -1.10, p<.0001); the difference between groups remained statistically significant at 24 months (-0.80 points, 95% CI -1.39 to -0.20, p = .009). There were two device-related serious adverse events in the second year that occurred at index vertebrae (a spondylitis and an anterior cement migration). There was no statistically significant difference between groups in the number of patients (47.5% for kyphoplasty, 44.1% for control) with new radiographic vertebral fractures; fewer fractures occurred (similar to 18%) within the second year. Compared with nonsurgical management, kyphoplasty rapidly reduces pain and improves function, disability, and quality of life without increasing the risk of additional vertebral fractures. The differences from nonsurgical management are statistically significant when averaged across 24 months. Most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points. (C) 2011 American Society for Bone and Mineral Research.
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| 2. |
- Wardlaw, Douglas, et al.
(författare)
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Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial
- 2009
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Ingår i: The Lancet. - 1474-547X. ; 373:9668, s. 1016-1024
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Tidskriftsartikel (refereegranskat)abstract
- Background Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures, which is intended to reduce pain and improve quality of life. We assessed the efficacy and safety of the procedure. Methods Adults with one to three acute vertebral fractures were eligible for enrolment in this randomised controlled trial at 21 sites in eight countries. We randomly assigned 300 patients by a computer-generated sequence to receive kyphoplasty treatment (n=149) or non-surgical care (n=151). The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary (PCS) score (scale 0-100) between the kyphoplasty and control groups. Quality of life and other efficacy measurements and safety were assessed up to 12 months. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00211211. Findings 138 participants in the kyphoplasty group and 128 controls completed follow-up at 1 month. By use of repeated measures mixed effects modelling, all 300 randomised participants were included in the analysis. Mean SF-36 PCS score improved by 7.2 points (95% CI 5.7-8.8), from 26.0 at baseline to 33.4 at 1 month, in the kyphoplasty group, and by 2.0 points (0.4-3.6), from 25.5 to 27.4, in the non-surgical group (difference between groups 5.2 points, 2.9-7.4; p<0.0001). The frequency of adverse events did not differ between groups. There were two serious adverse events related to kyphoplasty (haematoma and urinary tract infection); other serious adverse events (such as myocardial infarction and pulmonary embolism) did not occur perioperatively and were not related to procedure. Interpretation Our findings suggest that balloon Icyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option. Funding Medtronic Spine LLC.
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| 3. |
- Ranstam, Jonas, et al.
(författare)
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Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE)
- 2012
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Ingår i: BMC Medical Research Methodology. - : Springer Science and Business Media LLC. - 1471-2288. ; 12:35
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Tidskriftsartikel (refereegranskat)abstract
- Background: Clinical trial participants may be temporarily absent or withdraw from trials, leading to missing data. In intention-to-treat (ITT) analyses, several approaches are used for handling the missing information - complete case (CC) analysis, mixed-effects model (MM) analysis, last observation carried forward (LOCF) and multiple imputation (MI). This report discusses the consequences of applying the CC, LOCF and MI for the ITT analysis of published data (analysed using the MM method) from the Fracture Reduction Evaluation (FREE) trial. Methods: The FREE trial was a randomised, non-blinded study comparing balloon kyphoplasty with non-surgical care for the treatment of patients with acute painful vertebral fractures. Patients were randomised to treatment (1: 1 ratio), and stratified for gender, fracture aetiology, use of bisphosphonates and use of systemic steroids at the time of enrolment. Six outcome measures - Short-form 36 physical component summary (SF-36 PCS) scale, EuroQol 5-Dimension Questionnaire (EQ-5D), Roland-Morris Disability (RMD) score, back pain, number of days with restricted activity in last 2 weeks, and number of days in bed in last 2 weeks - were analysed using four methods for dealing with missing data: CC, LOCF, MM and MI analyses. Results: There were no missing data in baseline covariates values, and only a few missing baseline values in outcome variables. The overall missing-response level increased during follow-up (1 month: 14.5%; 24 months: 28%), corresponding to a mean of 19% missing data during the entire period. Overall patterns of missing response across time were similar for each treatment group. Almost half of all randomised patients were not available for a CC analysis, a maximum of 4% were not included in the LOCF analysis, and all randomised patients were included in the MM and MI analyses. Improved estimates of treatment effect were observed with LOCF, MM and MI compared with CC; only MM provided improved estimates across all six outcomes considered. Conclusions: The FREE trial results are robust as the alternative methods used for substituting missing data produced similar results. The MM method showed the highest statistical precision suggesting it is the most appropriate method to use for analysing the FREE trial data.
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| 4. |
- Van Meirhaeghe, Jan, et al.
(författare)
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A Randomized Trial of Balloon Kyphoplasty and Non-Surgical Management for Treating Acute Vertebral Compression Fractures: Vertebral Body Kyphosis Correction and Surgical Parameters.
- 2013
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Ingår i: Spine. - 0362-2436. ; 38:12, s. 971-983
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Tidskriftsartikel (refereegranskat)abstract
- Study Design. Multicenter randomized controlled trial.Objective. To compare the efficacy and safety of balloon kyphoplasty (BKP) to non-surgical management (NSM) over 24 months in patients with painful vertebral compression fractures (VCF).Summary of Background Data. Recently, several large randomized controlled trials have been conducted and reported how vertebral augmentation compares with NSM for patients with acute VCFs. Few of these trials report on the surgical aspects and radiographic vertebral deformity results.Methods. Adults with 1-3 VCF were randomized within 3 months of pain to undergo bilateral BKP (n = 149) or NSM (n = 151). Surgical parameters, subjective quality of life (QOL) assessments and objective functional (timed up and go [TUG]) and radiographic assessments were collected.Results. Compared with NSM, the BKP group had greater improvements in SF-36 physical component summary (PCS) scores at one month (5.4 points, 95%CI, 3.4-7.3; p<0.0001) and when averaged across the 24-months (overall treatment effect 2.7 points, 95% CI, 1.3-4.1; p<0.0001). The kyphoplasty group also had greater functionality by assessing TUG (overall treatment effect -2.5 seconds, 95% CI, -0.8 to -4.2; p = 0.0036). At 24 months, the change in index fracture kyphotic angulation was statistically significantly improved in the kyphoplasty group (average 3.1° of correction for kyphoplasty compared to 0.8° in the control, p = 0.003). Number of baseline prevalent fractures (p = 0.003) and treatment assignment (p = 0.004) are the most predictive variables for PCS improvement; however in BKP patients there may also be a link with kyphotic angulation. In BKP, the highest quart for kyphotic angulation correction had higher PCS improvement (13.4 points) compared to the quart having lowest correction of angulation (7.40 points, p = 0.0146 for difference). The most common adverse events (AEs) temporally related to surgery (i.e., within 30-days) were back pain (20 BKP, 11 NSM) new VCF (11 BKP, 7 NSM), nausea/vomiting (12 BKP, 4 NSM) and urinary tract infection (10 BKP, 3 NSM). Several other AEs were possibly related to patient positioning in the operating room.Conclusion. Compared with NSM, BKP improves patient QOL and pain averaged over 24-months and results in better improvement of index vertebral body kyphotic angulation. Peri-operative complications may be reduced with more care in patient positioning.
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| 5. |
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| 6. |
- Wardlaw, Douglas, et al.
(författare)
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Balloon kyphoplasty in patients with osteoporotic vertebral compression fractures
- 2012
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Ingår i: Expert Review of Medical Devices. - 1745-2422. ; 9:4, s. 423-436
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Forskningsöversikt (refereegranskat)abstract
- Balloon kyphoplasty (BKP) is a minimally invasive surgical procedure indicated for treatment of painful vertebral compression fractures. During BKP, cannulae are placed percutaneously into the vertebral body, allowing insertion of inflatable balloons. Inflating the balloons partially restores vertebral body height, compacts the bone and creates a cavity for placement of bone cement after balloon removal. Placement of the cement reduces and stabilizes the fracture. BKP differs from vertebroplasty in that it aims to restore vertebral height and reduce kyphotic deformity. Case reports and observational studies have consistently shown that BKP significantly reduces pain, increases mobility and functional capacity and improves quality of life for up to 3 years. Clinically significant adverse events have been rarely reported. These findings were confirmed in randomized and nonrandomized prospective controlled studies. The objective of this review is to describe the surgical procedures involved in BKP and to review the evidence supporting its use.
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