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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Percutaneous vertebroplasty as a treatment for osteoporotic vertebral compression fractures: a systematic review

WT Ploeg, AG Veldhuizen, B The, and MS Sietsma.

Review published: 2006.

CRD summary

This review concluded that there was insufficient evidence to determine the efficacy and safety of percutaneous vertebroplasty for painful osteoporotic vertebral compression fractures. Despite methodological weaknesses in the review process, the lack of good-quality evidence means that this conclusion is likely to be reliable.

Authors' objectives

To evaluate the efficacy and safety of percutaneous vertebroplasty for painful osteoporotic vertebral compression fractures.

Searching

PubMed, EMBASE and the Cochrane CENTRAL Register were searched to 2004 or 2005 for relevant articles; the search terms were reported. The reference lists of included studies were also checked. Studies were excluded unless the abstract (at least) was written in English, German, French or Dutch.

Study selection

Study designs of evaluations included in the review

Studies of any design were eligible for inclusion, provided they included at least 10 participants and followed them up for at least 6 months.

The included studies comprised controlled studies and case series. Mean follow-up varied from 6 to 65 months.

Specific interventions included in the review

Studies of percutaneous vertebroplasty were eligible for inclusion. Studies of kyphoplasty were excluded.

In the included studies, multiple interventions were common and among 793 patients there were 1,136 vertebroplasties. Several studies involved an unspecified cointervention after the procedure. In the single controlled study, the control was conservative treatment.

Participants included in the review

Studies of patients with osteoporotic compression fractures were eligible for inclusion. Studies of patients with haemangiomas or neoplasms were excluded.

Most of the studies in the review concerned patients with a history of incapacitating pain, which was unrelieved by conventional treatment. The mean age of the patients was 64 to 79 years (range: 34 to 99). The duration of pain prior to the procedure was usually at least 4 weeks, but ranged from less than a week to over a year. Most studies described screening participants with magnetic resonance imaging or computer tomography to exclude other diagnoses and confirm posterior vertebral wall continuity. The majority of the participants, but not all, were female.

Outcomes assessed in the review

Eligible studies measured efficacy and safety and used a clinical measure as an outcome.

Efficacy outcomes were pain and quality of life. They were measured using a visual analogue scale (VAS) for pain and/or a quality-of-life questionnaire such as the Nottingham Health Profile, the Oswestry Low Back Pain Disability Questionnaire, the Barthel Index or the Musculoskeletal Outcomes Data Evaluation and Management Scale.

Safety outcomes included cement leakage (detected by post-procedural imaging) and the incidence and location of new vertebral fractures.

How were decisions on the relevance of primary studies made?

Two reviewers selected the articles independently and consulted a third reviewer if they were unable to achieve consensus.

Assessment of study quality

Study validity was assessed using an adaptation of a published checklist (van Tulder 1997). The checklist considered assessment of randomisation and allocation concealment, presence of a control group, blinding, cointervention, validity of outcome measures, drop-out rates, clarity of eligibility criteria and length of follow-up. Levels of evidence were assigned using the model of the Oxford Centre for Evidence-Based Medicine.

Two reviewers applied the checklist independently and consulted a third reviewer if they were unable to achieve consensus.

Data extraction

A single reviewer extracted data on efficacy and safety.

The results for efficacy were reported descriptively within the text as the mean or median percentage change in pain or quality- of-life scores from baseline to follow-up, or as the percentage of patients whose pain decreased in excess of a predetermined threshold. In addition, the 'Response in percentage of patients at follow up' was recorded in a table, but it was unclear what these data represented.

The results for safety were reported in a table as the percentage of patients (or of treated vertebrae) who experienced specific short-term or long-term complications.

Methods of synthesis

How were the studies combined?

The studies were combined in a narrative, organised by outcome. The authors did not state that the data were pooled in a meta-analysis, though the text reported what appears to be a pooled result of the pain scores of 4 studies.

How were differences between studies investigated?

The authors did not systematically investigate how differences between the studies might relate to the study findings.

Results of the review

Fifteen articles (n=1,062) were included: 1 cohort study (n=79), 11 prospective case series (n=435) and 3 retrospective case series (n=548).

The quality of evidence was generally low as nearly all of the studies were case series, with high potential for confounding. Many studies (9 of the 15) administered (unspecified) cointerventions and several studies (5 of the 15) had high (37 to 50%) or undisclosed drop-out rates. Some used questionnaires of limited relevance and some were poorly reported. Some publication bias might have occurred as positive studies were more likely to have been published. Moreover four potentially relevant studies were excluded by the language restriction. There was a high degree of clinical heterogeneity between the studies.

Pain.

All studies apparently reported this outcome.

A cohort study (n=79) reported a statistically significant decrease in pain score in the intervention group, from 19 on a 25-point scale at baseline to 9 at 24 hours post-procedure (-52.6%), while the score in the control group, who received conservative treatment, changed from 20 to 19 (-5%). In 4 case series (n=284), there was a statistically significant decrease in VAS score from 7.8 on a 10-point scale at baseline to 3.1 within 24 hours of the procedure (-60.3%). Another case series (n=16) reported a decrease of over 50% for 44% of patients at 3 days post-procedure.

Most studies reported a statistically significant improvement in pain at long-term follow-up (mean 17 months, range 6: to 65), though 5 studies reported a non significant increase in pain score during follow-up.

Quality of life.

Eight studies reported this outcome.

The cohort study reported a 29% improvement in physical functioning (by the Barthel index) on day 1, with no improvement in the conservatively treated group. However, there was no difference between the groups at 6 or 12 months.

In 7 case series, the results for quality of life were mixed. Overall, most of the studies reported an improvement, though it was unclear in some cases whether this was statistically significant.

Safety.

All studies reported this outcome.

The authors stated that over all 15 studies a mean of 2.4% of patients experienced clinical complications (range: 0.4 to 15.4%). However, this estimate did not include cement leakage, which was reported in 3% to 76% of patients (13 studies). New fractures were reported in a mean of 17% of patients (range: 5.5 to 52) over long-term follow up (9 studies). One study reported no statistically significant evidence that the risk of vertebral fracture was higher in the vicinity of a cemented vertebra than elsewhere. Another study reported a significant increase in new fractures near the cemented vertebra.

Authors' conclusions

Currently there is insufficient controlled evidence to determine the efficacy of percutaneous vertebroplasty. Although the procedure has a low rate of clinical complications, there is a potential for such complications to be devastating. Controlled trials with long-term follow-up are required.

CRD commentary

The review question and inclusion criteria were clear. The search was adequate, though four potentially relevant studies were excluded by the language restrictions. Steps were taken to minimise bias and error in the review process by having two reviewers involved independently in the study selection and validity assessment. However, the data extraction was undertaken by only one reviewer, which could have introduced subjectivity into the process. The validity assessment was based on a tool designed for randomised controlled trials. This was largely inapplicable to the bulk of the studies in the review, which were case series.

Insufficient details were provided on the primary studies. The authors mentioned heterogeneity in the type of interventions and noted that cointervention was common, but no relevant details were provided. There was no systematic report of the results of each study, particularly with respect to pain outcomes, and no indication of levels of statistical significance such as p- values. The only controlled study was noted as having remarkable results at 6 weeks and at 6 to 12 months, but only the 24-hour results were reported in the publication. The narrative synthesis of studies did not include several of the studies, and it was unclear whether meta-analysis was performed and if so what methods were used. The authors commented that complication rates were low although cement leakage occurred in up to 75% of patients.

The authors were appropriately cautious about the value of case series evidence, but failed to provide adequate information to evaluate the cohort study in their review. However, despite methodological flaws in the review process, the dearth of controlled evidence means that their conclusions are likely to be reliable.

Implications of the review for practice and research

Practice: The authors did not clearly state any implications for practice.

Research: The authors stated that controlled trials with long-term follow-up are required to assess the efficacy and safety of percutaneous vertebroplasty.

Bibliographic details

Ploeg W T, Veldhuizen A G, The B, Sietsma M S. Percutaneous vertebroplasty as a treatment for osteoporotic vertebral compression fractures: a systematic review. European Spine Journal 2006; 15(12): 1749-1758. [PubMed: 16823557]

Indexing Status

Subject indexing assigned by NLM

MeSH

Fractures, Compression /surgery; Fractures, Spontaneous /surgery; Humans; Osteoporosis /complications; Spinal Fractures /surgery; Surgical Procedures, Minimally Invasive

AccessionNumber

12007005188

Database entry date

31/03/2008

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 16823557

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