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.     

Risks and benefits of percutaneous vertebroplasty or kyphoplasty in the management of osteoporotic vertebral fractures

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.     

Aktueller Stand der Vertebroplastie und Kyphoplastie in Deutschland

Objective

This study was performed to provide an overview of the current practice of balloon kyphoplasty (BKP) and percutaneous vertebroplasty (PVP) in Germany. All surgical departments were evaluated for indications, experience and expertise, and the complications.

Methods

Questionnaires were mailed to 1330 surgical departments.

Results

A total of 582 (43.76%) surveys were returned; 257 departments perform neither BKP nor PVP. Osteoporotic compression fractures and to a lesser extent hemangiomas and metastasis were treated. About 30% of the BKP users consider traumatic vertebral fractures in young patients as an indication, 76% of the respondents perform further spinal surgery, and 71% of the users operate within the first 2 weeks. For both interventions cement leakage is the most common complication.

Conclusion

Nationwide kyphoplasty and vertebroplasty are widely used by surgeons. The number of users as well as the annual number of cases in each center are increasing continuously. The partially incomplete present state of the studies must be validated by future high-quality, randomized studies.     

Percutaneous vertebroplasty versus balloon kyphoplasty for treatment of osteoporotic vertebral compression fracture: a meta-analysis of randomised and non-randomised controlled trials

Purpose  

There is still debate over whether vertebroplasty (VP) or kyphoplasty (KP) is superior for the treatment of osteoporosis vertebral compression fractures (VCFs). We performed a systematic review and meta-analysis of randomised and non-randomised controlled trials comparing VP with KP to reach a relatively conclusive answer.     

Vertebroplasty and kyphoplasty: complementary techniques for the treatment of painful osteoporotic vertebral compression fractures. A prospective non-randomised study on 154 patients

In a prospective study, we aimed to evaluate the potential use of kyphoplasty (KP) and vertebroplasty (VP) as complementary techniques in the treatment of painful osteoporotic vertebral compression fractures (VCFs). After 1 month of conservative treatment for VCFs, patients with intractable pain were offered treatment with KP or VP according to a treatment algorithm that considers time from fracture (Δt) and amount of vertebral body collapse. Bone biopsy was obtained intra-operatively to exclude patients affected by malignancy or osteomalacia. 164 patients were included according to the above criteria. Mean age was 67.6 years. Mean follow-up was 33 months. 10 patients (6.1%) were lost to follow-up and 154 reached the minimum 2-year follow-up. 118 (69.5%) underwent VP and 36 (30.5%) underwent KP. Complications affected five patients treated with VP, whose one suffered a transient intercostal neuropathy and four a subsequent VCF (two at adjacent level). Results in terms of visual analogue scale and Oswestry scores were not different among treatment groups. In conclusion, at an average follow-up of almost 3 years from surgical treatment of osteoporotic VCFs, VP and KP show similar good clinical outcomes and appear to be complementary techniques with specific different indications.     

Vertebroplasty and kyphoplasty: complementary techniques for the treatment of painful osteoporotic vertebral compression fractures. A prospective non-randomised study on 154 patients

In a prospective study, we aimed to evaluate the potential use of kyphoplasty (KP) and vertebroplasty (VP) as complementary techniques in the treatment of painful osteoporotic vertebral compression fractures (VCFs). After 1 month of conservative treatment for VCFs, patients with intractable pain were offered treatment with KP or VP according to a treatment algorithm that considers time from fracture (Δt) and amount of vertebral body collapse. Bone biopsy was obtained intra-operatively to exclude patients affected by malignancy or osteomalacia. 164 patients were included according to the above criteria. Mean age was 67.6 years. Mean follow-up was 33 months. 10 patients (6.1%) were lost to follow-up and 154 reached the minimum 2-year follow-up. 118 (69.5%) underwent VP and 36 (30.5%) underwent KP. Complications affected five patients treated with VP, whose one suffered a transient intercostal neuropathy and four a subsequent VCF (two at adjacent level). Results in terms of visual analogue scale and Oswestry scores were not different among treatment groups. In conclusion, at an average follow-up of almost 3 years from surgical treatment of osteoporotic VCFs, VP and KP show similar good clinical outcomes and appear to be complementary techniques with specific different indications.

     

Patterns of Treatment for Metastatic Pathological Fractures of the Spine: The Efficacy of Each Treatment Modality

Background

Metastatic pathological fractures of the spine are a major problem for cancer patients; however, there is no consensus on treatment strategy. The purpose of this study was to evaluate various treatment options by analyzing their patterns for metastatic pathological fractures of the spine.

Methods

In this study, 54 patients (male:female = 36:18) who were diagnosed with metastatic pathological fractures of spine were recruited. Demographic data, origin of cancer, type of treatment, and results were obtained from electronic medical records. Treatment options were divided into radiotherapy (RT), vertebroplasty (VP) or kyphoplasty (KP), operation (OP), and other treatments. Treatment results were defined as aggravation, no response, fair response, good response, and unknown. The survival time after detection of pathologic fractures was analyzed with the Kaplan-Meier method.

Results

The mean age of the patients was 62.3 years. Hepatocellular carcinoma was the most common cancer of primary origin (n = 9), followed by multiple myeloma (n = 8). RT was the most common primary choice of treatment (n = 29, 53.7%), followed by OP (n = 13, 24.1%), and VP or KP (n = 10, 18.5%). Only 13 of 29 RT cases and 7 of 13 OP cases demonstrated a fair or good response. The mean survival time following detection of pathological spinal fractures was 11.1 months for 29 patients, who died during the study period.

Conclusions

RT was the most common primary choice of treatment for metastatic pathological fractures of the spine. However, the response rate was suboptimal. Although OP should be considered for the relief of mechanical back pain or neurologic symptoms, care should be taken in determining the surgical indication. VP or KP could be considered for short-term control of localized pain, although the number of cases was too small to confirm the conclusion. It is difficult to determine the superiority of the treatment modalities, hence, a common guideline for the diagnosis and treatment of metastatic pathological fractures of the spine is required.     

Minimally Invasive Vertebral Augmentation Techniques in Osteoporotic Fractures

Abstract Minimally invasive vertebral augmentation techniques fill the gap between conservative treatment and open surgical fusion in the treatment of osteoporotic vertebral fractures. Both vertebroplasty (VP) and kyphoplasty (KP) have proven to be effective in the reinforcement of a fractured vertebral body and provide pain relief, but both procedures have technical differences. Furthermore, patient selection criteria are still under debate, as no randomized comparison trials of VP and KP exist. A competitive environment has arisen between both methods. In the authors’ opinion, VP and KP do not replace, but complement each other and offer both potential benefits. It is the purpose of this article to outline the different kinds of application of both methods.     

Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies

Purpose

To determine if differences in safety or efficacy exist between balloon kyphoplasty (BKP), vertebroplasty (VP) and non-surgical management (NSM) for the treatment of osteoporotic vertebral compression fractures (VCFs).

Methods

As of February 1, 2011, a PubMed search (key words: kyphoplasty, vertebroplasty) resulted in 1,587 articles out of which 27 met basic selection criteria (prospective multiple-arm studies with cohorts of ≥20 patients). This systematic review adheres to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines.

Results

Pain reduction in both BKP (?5.07/10 points, P?P?P?=?0.35). Subsequent fractures occurred more frequently in the NSM group (22?%) compared with VP (11?%, P?=?0.04) and BKP (11?%, P?=?0.01). BKP resulted in greater kyphosis reduction than VP (4.8o vs. 1.7°, P?P?=?0.04), along with a trend for disability improvement (P?=?0.08). Cement extravasation was less frequent in the BKP (P?=?0.01). Surgical intervention within the first 7?weeks yielded greater pain reduction than VCFs treated later.

Conclusions

BKP/VP provided greater pain relief and fewer subsequent fractures than NSM in osteoporotic VCFs. BKP is marginally favored over VP in disability improvement, and significantly favored in QOL improvement. BKP had a lower risk of cement extravasation and resulted in greater kyphosis correction. Despite this analysis being restricted to Level I and II studies, significant heterogeneity suggests that the current literature is delivering inconsistent messages and further trials are needed to delineate confounding variables.     

Augmentation von Wirbelkörperfrakturen mit einem neuen Calciumphosphat-Zement nach Ballon-Kyphoplastie

Question

Can the same levels of pain reduction and increase in function be achieved in kyphoplasty procedures with Calcibon as with polymethylmethacrylate (PMMA) cement?

Patients and methods

In a prospective, interdisciplinary single-center study, 99 patients (173 vertebral fractures) were treated with kyphoplasty. Augmentation was performed with PMMA in 66 cases (127 vertebral bodies) and with Calcibon in 33 patients (46 vertebral bodies). Outcome data were obtained with a VAS spine score and by radiomorphometric evaluation of X-rays before and after treatment.

Results

Pain and function improved in 87% of the patients; an average of 16% of the lost vertebral height was regained. A 9% cement leakage rate was observed with PMMA and 10% with Calcibon. There was no significant difference in pain reduction and radiomorphometric evaluation between the two techniques.

Conclusion

Kyphoplasty is a reliable, minimally invasive method to stabilize fractured vertebral bodies. Augmentation with Calcibon improves pain and function and enables the treated vertebral body to regain of height.     

椎体后凸成形术与椎体成形术生物力学比较

目的比较椎体后凸成形术（KP）与椎体成形术（VP）对骨质疏松性椎体压缩骨折（OVCF）椎体力学性能的影响。方法5具尸体取20个胸腰段骨质疏松单椎体标本,按配对设计,分配为球囊扩张椎体后凸成形术组（KP组）和椎体成形术组（VP组）。经轴向加载压缩25%,制成椎体压缩骨折,记录制成骨折时的最大载荷及刚度数据。KP组将椎体压缩骨折标本行球囊扩张椎体后凸成形术;VP组将椎体压缩骨折标本行椎体成形术。然后将骨水泥强化治疗的椎体再次经万能力学试验机轴向加载,记录治疗后最大载荷及刚度数据。结果KP组和VP组骨折治疗后椎体最大载荷均分别明显高于骨折前（P〈0.01）,而椎体刚度差异无统计学意义（P〉0.05）。KP组与VP组间比较治疗后椎体最大载荷差异无统计学意义（P〉0.05）,椎体刚度差异无统计学意义（P〉0.05）。结论KP和VP均可明显增加OVCF椎体的抗压强度和恢复刚度。     

Kyphoplastie und Vertebroplastie bei osteoporotischen Wirbelkörperkompressionsfrakturen

Background

We evaluated the efficacy and safety of kyphoplasty and vertebroplasty using the data presented in recently published papers with respect to pain relief, function, complication rate, and incidence of new vertebral fractures.

Methods

Detailed searches for English-language and German-language articles published between 2002 and 2009 were performed in a number of electronic databases. Because of the large number of case series, we considered only systematic reviews and controlled studies. The internal validity of reviews and studies was judged by two authors independently. Data extraction was performed by one author, and extracted data were checked for completeness and correctness by a second author.

Results

A total of eight systematic reviews, primarily summarizing results from case series, and 11 controlled studies, two of which were randomized controlled trials (RCTs), were included. Both kyphoplasty and vertebroplasty significantly reduce pain in the majority of patients and can lead to short-term and possibly long-term improvement of function. Kyphoplasty induces fewer clinically relevant complications than vertebroplasty does, and there is presently stronger evidence for its efficacy compared with vertebroplasty. There is inconclusive evidence about the risk of new fractures after kyphoplasty and vertebroplasty.

Conclusion

Both procedures seem to be equally effective, but kyphoplasty is safer than vertebroplasty. New results, specifically from RCTs comparing the two procedures, are needed to provide more definitive data.     

Vergütung der Kyphoplastie im DRG-System 2011/2012

Background

The treatment of osteoporotic vertebral fractures by means of kyphoplasty is an accepted and safe procedure.

Aim

In Germany the reimbursement for kyphoplasty and vertebroplasty differs greatly. The growing diversity of suppliers and systems makes a comparison possible and necessary. Besides the illustration of kyphoplasty in the German diagnosis-related group (G-DRG) system and the amendments for 2012 we analyzed the procedures and associated costs.

Method

Using the example of two manufacturers and different system approaches, both of which can be charged as kyphoplasty, we try to point out the importance of selecting exact comparison parameters. In particular material and treatment costs are compared for both methods.     

Comparison of vertebroplasty and kyphoplasty for complications

Vertebroplasty (VP) and kyphoplasty (KP) have been proven equally effective in providing pain relief in patients with vertebral compression fractures (VCF). Both have been reported to have multiple complications which, though rare, are potentially devastating. This literature review focuses on comparing the incidence of various types of complication of VP and KP. Local cement leakage and pulmonary cement embolism have been reported more commonly after VP than KP. It is questionable whether the relative risk of developing an adjacent level new fracture after VP is greater than after KP The relationship between a new VCF and each of these procedures has also not been clearly established. Although the majority of complications are clinically silent, their potential risks, which include a fatal outcome, should always be kept in mind by the practitioner.     

Effect of vertebroplasty with bone filler device and comparison with balloon kyphoplasty

Purpose

To evaluate the effect of vertebroplasty with a bone filler device compared with balloon kyphoplasty.

Methods

A total of 222 patients underwent operations from January 2008 to October 2012. One-level fractures numbered 169 (86.7 %) cases and two-level fractures numbered 26 (13.3 %). A total of 221 vertebral levels were analyzed consequently. Vertebral height, compression ratio, and segmental Cobb’s angle were measured in preoperative and postoperative lateral X-rays.

Results

The compression ratio was the most influential parameter among three variables. Adjusted postoperative compression ratio was not significantly different between two operation groups. Bone cement leakage rates did not differ (p < 0.05). Bone cement distribution was spongy type in the majority of the vertebroplasty with bone filler device (94.5 %), but only in 42.0 % of the kyphoplasty. High bone densitometry readings and long period from diagnosis to operation were significant risk factors for bone cement leakage.

Conclusions

Vertebroplasty with a bone filler device could achieve equivalent compression reduction and bone cement leakage rate, as well as greater sponge-type bone cement distribution, which were advantages over balloon kyphoplasty.     

What is the importance of “halo” phenomenon around bone cement following vertebral augmentation for osteoporotic compression fracture?

Summary

We investigated the importance, risk factors, and clinical course of the radiolucent “halo” phenomenon around bone cement following vertebral augmentation for osteoporotic compression fracture. Preoperative osteonecrosis and a lump cement pattern were the most important risk factors for the peri-cement halo phenomenon, and it was associated with vertebral recollapse.

Introduction

We observed a newly developed radiolucent area around the bone cement following vertebral augmentation for osteoporotic compression fractures. Here, we describe the importance of the peri-cement halo phenomenon, as well as any associated risk factors and long-term sequelae.

Methods

In total, 175 patients (202 treated vertebrae) were enrolled in this study. The treated vertebrae were subdivided into two groups: Group A (with halo, n?=?32) and Group B (without halo, n?=?170), and the groups were compared with respect to multiple preoperative (age, sex, BMD, preoperative osteonecrosis) and perioperative factors (operative approach: vertebroplasty or kyphoplasty; cement distribution pattern; cement leakage; cement volume), and postoperative results (VAS score, recollapse). Logistic regression analysis was used to evaluate the relationship between the incidence of the peri-cement halo and all of the parameters described above.

Results

Rates of osteonecrosis were also significantly higher in Group A than in Group B (62.5% vs. 31.2%, p?p?p?p?p?=?0.001), KP (OR?=?3.630; 95% CI?=?1.628–8.095; p?=?0.002), lump pattern (OR?=?13.870; 95% CI?=?2.907–66.188; p?=?0.001), and vertebral recollapse (OR?=?5.356; 95% CI?=?1.897–15.122; p?=?0.002) were significantly associated with peri-cement halo.

Conclusions

The peri-cement halo was found to be associated with vertebral recollapse, this sign likely represents a poor prognostic factor after vertebral augmentation for osteoporotic compression fractures.     

Balloon kyphoplasty versus percutaneous vertebroplasty for treatment of osteoporotic vertebral compression fractures (OVCFs)

Summary

The study investigated whether kyphoplasty (KP) was superior to vertebroplasty (VP) in treating patients with osteoporotic vertebral compression fractures (OVCFs). KP may be superior to VP for treating patients with OVCFs based on long-term VAS and ODI but not short-term VAS. Further large-scale trials are needed to verify these findings due to potential risk of selection bias.

Introduction

This study aimed to assess whether KP was superior to VP in treating patients with OVCFs.

Methods

The Medline, Embase, and Cochrane databases and references within articles and proceedings of major meetings were systematically searched. Eligible studies included patients with OVCFs who received either KP or VP. Standard mean differences (SMDs) and relative risks (RRs) were used as measures of efficacy and safety in a random-effects model.

Results

Eleven studies enrolling 869 patients with OVCFs were identified as eligible for final analysis. Compared with VP, KP was associated with significant improvements in long-term (SMD, ?0.70; 95 % confidence interval [CI]: ?1.30, ?0.10; P?=?0.023) visual analog scale (VAS); short-term (SMD, ?1.50; 95 % CI: ?2.94, ?0.07; P?=?0.040) and long-term (SMD, ?1.03; 95 % CI: ?1.88, ?0.18; P?=?0.017) Oswestry Disability Indexes (ODIs); short-term (SMD, ?0.74; 95 % CI: ?1.42, ?0.06; P?=?0.032) and long-term (SMD, ?0.71; 95 % CI: ?1.19, ?0.23; P?=?0.004) kyphosis angles; and vertebral body height (SMD, 1.56; 95 % CI: 0.62, 2.49; P?=?0.001) and anterior vertebral body height (SMD, 3.04; 95 % CI: 0.53, 5.56; P?=?0.018). KP was also associated with a significantly longer operation time (SMD, 0.73; 95 % CI: 0.26, 1.19; P?=?0.002) and a lower risk of cement extravasation (RR, 0.68; 95 % CI: 0.48, 0.96; P?=?0.030) compared with VP. No significant differences were found in the short-term VAS, posterior vertebral body height, and adjacent-level fractures.

Conclusion

Acknowledging some risk of selection bias, KP displayed a significantly better performance compared with VP only in one of the two primary endpoints, that is, for ODI but not for short-term VAS. Further randomized studies are required to confirm these results.

     

Vertebroplasty and Kyphoplasty in Spinal Trauma

Abstract Kyphoplasty and vertebroplasty have become recognized procedures for the treatment of vertebral fractures, especially in patients with osteoporosis. In most cases of osteoporotic spinal vertebral fracture in elderly patients, polymethylmethacrylate (PMMA) cement is used to fill the defect and stabilize the vertebral body. The techniques of vertebroplasty and kyphoplasty differ in the possibility of realignment and reconstruction of the vertebral body and spinal column. Long-term results in terms of integration of the cement and bioreactivity of the vertebral body are still lacking; so, these procedures are still no options in the treatment of younger patients. Vertebroplasty and kyphoplasty show different success in the management of fresh traumatic spine fractures. The acute traumatic vertebral fracture has to be classified sensitively, to find the right indication for cement augmentation. Mild acute compression fractures can be treated by vertebroplasty or kyphoplasty, severe compression and burst fractures by combination of internal fixation and kyphoplasty. The indications for use of biological or osteoinductive cement in spinal fracture management must still be regarded as restricted owing to the lack of basic biomechanical research data. Such cement should not be used except in clinical studies.