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Health Technology Assessment... Mar 2014Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure in which bone cement is injected into a fractured vertebra. Percutaneous balloon kyphoplasty... (Review)
Review
Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral fractures: a systematic review and cost-effectiveness analysis.
BACKGROUND
Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure in which bone cement is injected into a fractured vertebra. Percutaneous balloon kyphoplasty (BKP) is a variation of this approach, in which an inflatable balloon tamp is placed in the collapsed vertebra prior to cement injection.
OBJECTIVES
To systematically evaluate and appraise the clinical effectiveness and cost-effectiveness of PVP and percutaneous BKP in reducing pain and disability in people with osteoporotic vertebral compression fractures (VCFs) in England and Wales.
DATA SOURCES
A systematic review was carried out. Ten databases including MEDLINE and CINAHL were searched from inception to November 2011, and supplemented by hand-searching relevant articles and contact with an expert. Studies met the inclusion criteria if they were randomised controlled trials (RCTs) including people with painful osteoporotic VCFs with a group receiving PVP or BKP. In addition, lead authors of identified RCTs were contacted for unpublished data.
REVIEW METHODS
Primary outcomes were health-related quality of life; back-specific functional status/mobility; pain/analgesic use; vertebral body height and angular deformity; incidence of new vertebral fractures and progression of treated fracture. A manufacturer provided academic-in-confidence observational data indicating that vertebral augmentation may be associated with a beneficial mortality effect, and that, potentially, BKP was more efficacious than PVP. These data were formally critiqued. A mathematical model was constructed to explore the cost-effectiveness of BKP, PVP and operative placebo with local anaesthesia (OPLA) compared with optimal pain management (OPM). Six scenario analyses were conducted that assessed combinations of assumptions on mortality (differential beneficial effects for BKP and PVP; equal beneficial effects for BKP and PVP; and no effect assumed) and derivation of utility data (either mapped from visual analogue scale pain score data produced by a network meta-analysis or using direct European Quality of Life-5 Dimensions data from the trials). Extensive sensitivity analyses were conducted on each of the six scenarios. This report contains reference to confidential information provided as part of the National Institute for Health and Care Excellence appraisal process. This information has been removed from the report and the results, discussions and conclusions of the report do not include the confidential information. These sections are clearly marked in the report.
RESULTS
A total of nine RCTs were identified and included in the review of clinical effectiveness. This body of literature was of variable quality, with the two double-blind, OPLA-controlled trials being at the least risk of bias. The most significant methodological issue among the remaining trials was lack of blinding for both study participants and outcome assessors. Broadly speaking, the literature suggests that both PVP and BKP provide substantially greater benefits than OPM in open-label trials. However, in double-blinded trials PVP was shown to have no more benefit than local anaesthetic; no trials of BKP compared with local anaesthesia have been conducted. A formal analysis of observational mortality data undertaken within this report concluded that it was not possible to say with certainty if there is a difference in mortality between patients undergoing BKP and PVP compared with OPM. Results from the cost-effectiveness analyses were varied, with all of BKP, PVP and OPLA appearing the most cost-effective treatment dependent on the assumptions made regarding mortality effects, utility, hospitalisation costs and OPLA costs.
LIMITATIONS
Data on key parameters were uncertain and/or potentially confounded, making definitive conclusions difficult to make.
CONCLUSION
For people with painful osteoporotic VCFs refractory to analgesic treatment, PVP and BKP perform significantly better in unblinded trials than OPM in terms of improving quality of life and reducing pain and disability. However, there is as yet no convincing evidence that either procedure performs better than OPLA. The uncertainty in the evidence base means that no definitive conclusion on the cost-effectiveness of PVP or BKP can be provided. Further research should focus on establishing whether or not BKP and PVP have a mortality advantage compared with OPLA and on whether or not these provide any utility gain compared with OPLA.
STUDY REGISTRATION
This study was registered as PROSPERO number CRD42011001822.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Back Pain; Bone Cements; Cost-Benefit Analysis; England; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Quality of Life; Randomized Controlled Trials as Topic; Recovery of Function; Spinal Fractures; Technology Assessment, Biomedical; Vertebroplasty
PubMed: 24650687
DOI: 10.3310/hta18170 -
BMJ Case Reports Jul 2019
Topics: Aged, 80 and over; Bone Cements; Dyspnea; Echocardiography; Embolism; Female; Humans; Pulmonary Embolism; Tomography, X-Ray Computed; Treatment Outcome; Vertebroplasty
PubMed: 31311789
DOI: 10.1136/bcr-2019-230603 -
Annals of Saudi Medicine 2016Both kyphoplasty (KP) and vertebroplasty (VP) are effective for patients with osteoporotic vertebral compression fracture (OVCF), but which approach might be more... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Both kyphoplasty (KP) and vertebroplasty (VP) are effective for patients with osteoporotic vertebral compression fracture (OVCF), but which approach might be more effective remains unclear, so we decided to update earlier systematic reviews.
OBJECTIVE
Review and analyze studies published as of August 2015 that compared clinical outcomes and complications of KP versus VP.
DESIGN
Systematic review and meta-analysis.
SEARCH METHOD
Published reports up to August 2015 were found in PubMed, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL).
SELECTION CRITERIA
Randomized controlled trials (RCTs) and prospective and retrospective cohort stud.ies comparing KP and VP in patients with OVCF.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed the studies and extracted data.
RESULTS
Thirty-two studies involving 3274 patients fulfilled the inclusion criteria. There were significant differences between the two groups in short- and long-term postoperative changes in measures of pain intensity and dysfunction (P < .01), in anterior and middle height (P < .01), kyphotic angle (P < .01), and time to injury, but not in posterior height (P=.178). There were no significant differences in the rate of postoperative fractures including adjacent and total fractures, but cement leakage to the intraspinal space was greater in the VP group (P=.035). KP surgery took longer and required a greater volume of injected cement.
CONCLUSIONS
KR resulted in better pain relief, improvements in Oswestry dysfunction and radiographic outcomes with less cement leakage, but further RCTs are needed to verify this conclusion.
LIMITATIONS
Only four RCTs with a certain of risk of bias. Most studies were observational.
Topics: Bone Cements; Disability Evaluation; Fractures, Compression; Humans; Kyphoplasty; Operative Time; Osteoporotic Fractures; Pain Measurement; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 27236387
DOI: 10.5144/0256-4947.2016.165 -
Der Orthopade Apr 2009Osteolytic lesions of the spine (metastasis, myeloma) can be treated extremely efficiently by percutaneous cement injection. The treatment should be restricted to... (Review)
Review
Osteolytic lesions of the spine (metastasis, myeloma) can be treated extremely efficiently by percutaneous cement injection. The treatment should be restricted to osteolytic lesions of the vertebral body, and only if a relevant mechanical deterioration is present. If the pedicles and/or the lamina are involved and if there is compression of the spinal canal, the treatment is no longer appropriate. The surgical technique is similar to the treatment of osteoporotic fractures; however, there is definitely a higher risk for cement leakage and the clinical outcome is not as predictable as in osteoporotic fracture treatment. It is important to realize that cement injection per se has no impact on the tumor itself, but provides stability to the vertebral body. An osteolytic lesion without mechanical compromise does not need a vertebroplasty. Patients with tumorous lesions of the spine should be followed by an interdisciplinary team of spine surgeon, oncologist and radio-oncologist.
Topics: Bone Cements; Humans; Injections, Intralesional; Spinal Fractures; Spinal Neoplasms; Vertebroplasty
PubMed: 19229516
DOI: 10.1007/s00132-008-1377-3 -
AJNR. American Journal of Neuroradiology Oct 2018
Topics: Humans; Kyphoplasty; Motivation; Radiology, Interventional; Spinal Fractures; Vertebroplasty
PubMed: 30213815
DOI: 10.3174/ajnr.A5762 -
The Spine Journal : Official Journal of... Oct 2016Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure and is frequently performed in humans who need surgical treatment of vertebral fractures....
BACKGROUND CONTEXT
Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure and is frequently performed in humans who need surgical treatment of vertebral fractures. PVP involves cement injection into the vertebral body, thereby providing rapid and significant pain relief.
PURPOSE
The testing of novel biomaterials depends on suitable animal models. The aim of this study was to develop a reproducible and safe model of PVP in sheep.
STUDY DESIGN
This study used ex vivo and in vivo large animal model study (Merino sheep).
METHODS
Ex vivo vertebroplasty was performed through a bilateral modified parapedicular access in 24 ovine lumbar hemivertebrae, divided into four groups (n=6). Cerament (Bone Support, Lund, Sweden) was the control material. In the experimental group, a novel composite was tested-Spine-Ghost-which consisted of an alpha-calcium sulfate matrix enriched with micrometric particles of mesoporous bioactive glass. All vertebrae were assessed by micro-computed tomography (micro-CT) and underwent mechanical testing. For the in vivo study, 16 sheep were randomly allocated into control and experimental groups (n=8), and underwent PVP using the same bone cements. All vertebrae were assessed postmortem by micro-CT, histology, and reverse transcription-polymerase chain reaction (rt-PCR). This work has been supported by the European Commission under the 7th Framework Programme for collaborative projects (600,000-650,000 USD).
RESULTS
In the ex vivo model, the average defect volume was 1,275.46±219.29 mm. Adequate defect filling with cement was observed. No mechanical failure was observed under loads which were higher than physiological. In the in vivo study, cardiorespiratory distress was observed in two animals, and one sheep presented mild neurologic deficits in the hind limbs before recovering.
CONCLUSIONS
The model of PVP is considered suitable for preclinical in vivo studies, mimicking clinical application. All sheep recovered and completed a 6-month implantation period. There was no evidence of cement leakage into the vertebral foramen in the postmortem examination.
Topics: Animals; Bone Cements; Calcium Sulfate; Disease Models, Animal; Drug Combinations; Durapatite; Minimally Invasive Surgical Procedures; Sheep; Spinal Fractures; Vertebroplasty
PubMed: 27374111
DOI: 10.1016/j.spinee.2016.06.011 -
PloS One 2015Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic... (Review)
Review
CONTEXT
Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic evaluations, particularly for innovative devices, such as those used in vertebroplasty and kyphoplasty.
OBJECTIVE
To assess the level of evidence provided by the available economic evaluations for vertebroplasty and kyphoplasty.
DATA SOURCES
A systematic review of articles in English or French listed in the MEDLINE, PASCAL, COCHRANE and National Health Service Economic Evaluation databases, with limits on publication date (up to the date of the review, March 2014).
STUDY SELECTION
We included only economic evaluations of vertebroplasty or kyphoplasty. Editorial and methodological articles were excluded.
DATA EXTRACTION
Data were extracted from articles by two authors working independently and using two analysis grids to measure the quality of economic evaluations.
DATA SYNTHESIS
Twenty-one studies met our inclusion criteria. All were published between 2008 and 2014. Eighteen (86%) were full economic evaluations. Cost-effectiveness analysis (CEA) was the most frequent type of economic evaluation, and was present in 11 (52%) studies. Only three CEAs complied fully with the British Medical Journal checklist. The quality of the data sources used in the 21 studies was high, but the CEAs conforming to methodological guidelines did not use high-quality data sources for all components of the analysis.
CONCLUSIONS
This systematic review shows that the level of evidence in economic evaluations of vertebroplasty and kyphoplasty is low, despite the recent publication of a large number of studies. This finding highlights the challenges to be faced to improve the quality of economic evaluations of medical devices.
Topics: Cost-Benefit Analysis; Equipment and Supplies; Humans; Kyphoplasty; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Vertebroplasty
PubMed: 26661078
DOI: 10.1371/journal.pone.0144892 -
BMC Surgery Jan 2021Percutaneous vertebroplasty (PVP) and kyphoplasty (PKP) have been widely used to treat neurologically intact osteoporotic Kümmell's disease (KD), but it is still...
BACKGROUND
Percutaneous vertebroplasty (PVP) and kyphoplasty (PKP) have been widely used to treat neurologically intact osteoporotic Kümmell's disease (KD), but it is still unclear which treatment is more advantageous. Our study aimed to compare and investigate the safety and clinical efficacy of PVP and PKP in the treatment of KD.
METHODS
The relevant data that 64 patients of neurologically intact osteoporotic KD receiving PVP (30 patients) or PKP (34 patients) were analyzed. Surgical time, operation costs, intraoperative blood loss, volume of bone cement injection, and fluoroscopy times were compared. Occurrence of cement leakage, transient fever and re-fracture were recorded. Universal indicators of visual analogue scale (VAS) and Oswestry disability index (ODI) were evaluated separately before surgery and at 1 day, 6 months, 1 year, 2 years and the final follow-up after operation. The height of anterior edge of the affected vertebra and the Cobb's angle were assessed by imaging.
RESULTS
All patients were followed up for at least 24 months. The volume of bone cement injection, intraoperative blood loss, occurrence of bone cement leakage, transient fever and re-fracture between two groups showed no significant difference. The surgical time, the operation cost and fluoroscopy times of the PKP group was significantly higher than that of the PVP group. The post-operative VAS, ODI scores, the height of the anterior edge of the injured vertebrae and kyphosis deformity were significantly improved in both groups compared with the pre-operation. The improvement of vertebral height and kyphosis deformity in PKP group was significantly better than that in the PVP group at every same time point during the follow-up periods, but the VAS and ODI scores between the two groups showed no significant difference.
CONCLUSION
PVP and PKP can both significantly alleviate the pain of patients with KD and obtain good clinical efficacy and safety. By contrast, PKP can achieve better imaging height and kyphosis correction, while PVP has the advantages of shorter operation time, less radiation volume and operation cost.
Topics: Aged; Aged, 80 and over; Bone Cements; Female; Fractures, Compression; Humans; Kyphoplasty; Male; Minimally Invasive Surgical Procedures; Osteoporotic Fractures; Retrospective Studies; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 33514359
DOI: 10.1186/s12893-021-01057-x -
Revue de Chirurgie Orthopedique Et... Sep 2006
Topics: Humans; Osteoporosis; Spinal Diseases; Spinal Injuries; Spinal Neoplasms; Vertebroplasty
PubMed: 17088781
DOI: No ID Found -
European Spine Journal : Official... Sep 2012To assess the safety and efficacy of balloon kyphoplasty (KP) compared with percutaneous vertebroplasty (VP) and provide recommendations for using these procedures to... (Meta-Analysis)
Meta-Analysis Review
Balloon kyphoplasty versus percutaneous vertebroplasty in treating osteoporotic vertebral compression fracture: grading the evidence through a systematic review and meta-analysis.
OBJECTIVE
To assess the safety and efficacy of balloon kyphoplasty (KP) compared with percutaneous vertebroplasty (VP) and provide recommendations for using these procedures to treat osteoporotic vertebral compression fractures (OVCF).
METHODS
A systematic search of all studies published through March 2012 was conducted using the MEDLINE, EMBASE, OVID, ScienceDirect and Cochrane CENTRAL databases. The randomized controlled trials (RCTs) and non-randomized controlled trials that compared KP to VP and provided data on safety and clinical effects were identified. Demographic characteristics, adverse events and clinical outcomes were manually extracted from all of the selected studies. The evidence quality levels and recommendations were assessed using the GRADE system.
RESULTS
Twelve studies encompassing 1,081 patients met the inclusion criteria. Subgroup meta-analyses were performed according to the study design. In the RCT subgroup, there were significant differences between the two procedures in short-term visual analog scale (VAS), long-term kyphosis angles, operative times and anterior vertebrae heights. In the cohort study subgroup, there were significant differences between the two procedures in short- and long-term VAS, short- and long-term Oswestry Disability Index (ODI), cement leakage rates, short- and long-term kyphosis angles, operative times and anterior vertebrae heights. However, there were no significant differences in long-term VAS or adjacent vertebral fracture rates in the RCT subgroup. There were no significant differences in short- or long-term VAS, short- or long-term ODI, cement leakage rates, adjacent vertebral fracture rates, short- or long-term kyphosis angles or anterior vertebrae heights in the CCT subgroup, and the adjacent vertebral fracture rates did not differ significantly in the cohort study subgroup. The overall GRADE system evidence quality was very low, which lowers our confidence in their recommendations.
CONCLUSIONS
KP and VP are both safe and effective surgical procedures for treating OVCF. KP may be superior to VP in patients with large kyphosis angles, vertebral fissures, fractures in the posterior edge of the vertebral body or significant height loss in the fractured vertebrae. Due to the poor quality of the evidence currently available, high-quality RCTs are required.
Topics: Fractures, Compression; Humans; Kyphoplasty; Minimally Invasive Surgical Procedures; Osteoporotic Fractures; Pain; Recovery of Function; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 22832872
DOI: 10.1007/s00586-012-2441-6