Comparison of unipedicular and bipedicular balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures A PROSPECTIVE RANDOMISED STUDY

Hospital for Special Surgery, 535 East 70th Street, New York, New York 10021, USA.
Bone and Joint Journal (Impact Factor: 1.96). 03/2013; 95-B(3):401-6. DOI: 10.1302/0301-620X.95B3.29819
Source: PubMed


This is a prospective randomised study comparing the clinical and radiological outcomes of uni- and bipedicular balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. A total of 44 patients were randomised to undergo either uni- or bipedicular balloon kyphoplasty. Self-reported clinical assessment using the Oswestry Disability Index, the Roland-Morris Disability questionnaire and a visual analogue score for pain was undertaken pre-operatively, and at three and twelve months post-operatively. The vertebral height and kyphotic angle were measured from pre- and post-operative radiographs. Total operating time and the incidence of cement leakage was recorded for each group. Both uni- and bipedicular kyphoplasty groups showed significant within-group improvements in all clinical outcomes at three months and twelve months after surgery. However, there were no significant differences between the groups in all clinical and radiological outcomes. Operating time was longer in the bipedicular group (p < 0.001). The incidence of cement leakage was not significantly different in the two groups (p = 0.09). A unipedicular technique yielded similar clinical and radiological outcomes as bipedicular balloon kyphoplasty, while reducing the length of the operation. We therefore encourage the use of a unipedicular approach as the preferred surgical technique for the treatment of osteoporotic vertebral compression fractures. Cite this article: Bone Joint J 2013;95-B:401-6.

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    • "However, both biomechanical data [96–98] and clinical series [99–102] suggest that unipedicular procedure is safe and effective. Comparative studies also claim no difference in clinical or radiological parameters [103–106] with the exception of a retrospective study by Chung and coauthors who found same pain reduction but superior kyphosis restoration with bipedicular approach [107]. Only difference may be the smaller cement amount filling in unilateral operations [103, 104], which may be as low as 0.8 cc as seen from our data. "
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    ABSTRACT: Kyphoplasty (KP) and vertebroplasty (VP) have been successfully employed for many years for the treatment of osteoporotic vertebral fractures. The purpose of this review is to resolve the controversial issues raised by the two randomized trials that claimed no difference between VP and SHAM procedure. In particular we compare nonsurgical management (NSM) and KP and VP, in terms of clinical parameters (pain, disability, quality of life, and new fractures), cost-effectiveness, radiological variables (kyphosis correction and vertebral height restoration), and VP versus KP for cement extravasation and complications profile. Cement types and optimal filling are analyzed and technological innovations are presented. Finally unipedicular/bipedicular techniques are compared. Conclusion. VP and KP are superior to NSM in clinical and radiological parameters and probably more cost-effective. KP is superior to VP in sagittal balance improvement and cement leaking. Complications are rare but serious adverse events have been described, so caution should be exerted. Unilateral procedures should be pursued whenever feasible. Upcoming randomized trials (CEEP, OSTEO-6, STIC-2, and VERTOS IV) will provide the missing link.
    Full-text · Article · Mar 2014
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    ABSTRACT: Percutaneous vertebroplasty (PKP) has proved its effectiveness regarding minimal invasion, rapid pain reduction, safe cement augmentation, restoring vertebral height, and accelerating complete recovery of osteoporotic vertebral compression fractures (OVCFs). Whether unipedicular or bipedicular PKP provides a better outcome is controversial. We searched PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Web of Knowledge, Chinese Biomedical Literature Database, and Wanfang Data from January 1980 to March 2013 with "kyphoplasty", "unipedicular", "bipedicular", "compression fracture", and "randomized controlled trial". Risk of bias in the included studies was assessed according to a 12-item scale. Meta-analysis was performed. Dichotomous and continuous variables were calculated using the odds ratio (OR) and standardized mean difference (SMD), respectively. Seven studies involving 440 patients and 559 vertebral bodies met the criteria for inclusion. Among them, one randomized controlled trial had a high risk of bias and six a low risk. The pain visual analogue scale (VAS) SMDs were -0.02 (P = 0.88) for short-term follow-up (≤3 months) and 0.03 (P = 0.82) for long-term follow-up (≥ 1 year). Oswestry Disability Index (ODI) SMDs at short- and long-term follow-up were not statistically significant (-0.04, P = 0.77 and -0.07, P = 0.74, respectively). This meta-analysis showed greater polymethylmethacrylate volume (SMD -1.08, P = 0.00) and operation time (SMD -2.40, P = 0.00), favoring unipedicular PKP. Radiographic outcomes-preoperative kyphosis angle, restoration rate, reduction angle, loss of reduction angle-were not statistically different between the groups. Pooled analyses of cement leakage and subsequent adjacent OVCFs showed no significant differences between the groups, with OR = 0.82 (P = 0.79) and OR = 1.41 (P = 0.70), respectively. This meta-analysis comparing unipedicular and bipedicular PKP demonstrated no significant differences regarding VAS, ODI, radiographic outcomes, or complications. Considering the longer operation time and radiation exposure with bipedicular PKP, we recommend unipedicular PKP over bipedicular PKP for treating OVCFs.
    No preview · Article · Oct 2013 · Chinese medical journal
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    ABSTRACT: Vertebral fracture (VF) is the most common osteoporotic fracture and is associated with high morbidity and mortality. Conservative treatment combining antalgic agents and rest is usually recommended for symptomatic VFs. The aim of this paper is to review the randomized controlled trials comparing the efficacy and safety of percutaneous vertebroplasty (VP) and percutaneous balloon kyphoplasty (KP) versus conservative treatment. VP and KP procedures are associated with an acceptable general safety. Although the case series investigating VP/KP have all shown an outstanding analgesic benefit, randomized controlled studies are rare and have yielded contradictory results. In several of these studies, a short-term analgesic benefit was observed, except in the prospective randomized sham-controlled studies. A long-term analgesic and functional benefit has rarely been noted. Several recent studies have shown that both VP and KP are associated with an increased risk of new VFs. These fractures are mostly VFs adjacent to the procedure, and they occur within a shorter time period than VFs in other locations. The main risk factors include the number of preexisting VFs, the number of VPs/KPs performed, age, decreased bone mineral density, and intradiscal cement leakage. It is therefore important to involve the patients to whom VP/KP is being proposed in the decision-making process. It is also essential to rapidly initiate a specific osteoporosis therapy when a VF occurs (ideally a bone anabolic treatment) so as to reduce the risk of fracture. Randomized controlled studies are necessary in order to better define the profile of patients who likely benefit the most from VP/KP.
    No preview · Article · Nov 2013 · Osteoporosis International
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