Sky Bone Expander Research Articles

Trends in Vertebral Augmentation Practice for Osteoporotic Vertebral Fracture

Osteoporosis is characterized by low bone mass, primarily affecting older individuals and a common complication is vertebral fractures. The collapse-induced height loss in vertebrae can result in spinal instability and progressive kyphotic deformity. Surgical intervention for osteoporotic vertebrae poses challenges due to poor bone quality and frequent medical comorbidities. In recent years, it has become the predominant method for vertebral augmentation in acute fractures, aiming to relieve pain, strengthen the vertebral structure, and prevent deformities by restoring height. These procedures involve percutaneous placement of cannulas into each collapsed vertebral body through a unipedicular or bipedicular approach.
 Novel products are emerging to strengthen vertebrae in treating osteoporotic compression fractures. Balloon kyphoplasty and vertebroplasty are widely accepted and recognized as effective vertebral augmentation methods. Treatment guidelines are evolving with the introduction of innovative systems like Vertebral Body Stenting, Titanium Mesh, and Sky Bone Expander, claiming to achieve exceptional vertebral height restoration. Controversies persist regarding the optimal timing for vertebral augmentation post-fracture.
 Polymethylmethacrylate cement is extensively used to stabilize fractured vertebral bodies. Additionally, new calcium phosphate-based nanocomposite cements are gaining prominence. These advancements underscore the ongoing development in the treatment of osteoporotic vertebral compression fractures. Each innovative implant introduces unique features and indications. Precise confirmation of the source of the painful fracture is crucial for effective and safe treatment, ensuring proper timing and indication.

Innovative minimally invasive implants for osteoporosis vertebral compression fractures.

With increasing population aging, osteoporosis vertebral compression fractures (OVCFs), resulting in severe back pain and functional impairment, have become progressively common. Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) as minimally invasive procedures have revolutionized OVCFs treatment. However, PVP- and PKP-related complications, such as symptomatic cement leakage and adjacent vertebral fractures, continue to plague physicians. Consequently, progressively more implants for OVCFs have been developed recently to overcome the shortcomings of traditional procedures. Therefore, we conducted a literature review on several new implants for OVCFs, including StaXx FX, Vertebral Body Stenting, Vesselplasty, Sky Bone Expander, Kiva, Spine Jack, Osseofix, Optimesh, Jack, and V-strut. Additionally, this review highlights the individualized applications of these implants for OVCFs. Nevertheless, current clinical studies on these innovative implants remain limited. Future prospective, randomized, and controlled studies are needed to elucidate the effectiveness and indications of these new implants for OVCFs.

Comparison of Clinical Outcomes and Radiographic Measurements in 4 Different Treatment Modalities for Osteoporotic Compression Fractures

We conducted a retrospective analysis of a prospectively collected database in a tertiary hospital over 10 years. Treatment for vertebral compression fractures remains an area of controversy with respect to timing and type of surgical management. We analyzed the clinical outcomes and radiographic measurements of 4 different modalities of treatment for these fractures. From 2001 to 2011, we analyzed a total of 363 patients after failure of 30 days of conservative management. These patients were then further managed either conservatively or with vertebroplasty, balloon kyphoplasty, or sky bone expander. Outcomes were assessed by using self-report measures: Visual Analog Score; functional measures: Oswestry Disability Index and Short-Form 36; and physiological measures: preoperative and postoperative radiographs. The outcome measures were assessed for 6 months for those treated conservatively and up till 2 years for those treated surgically. Radiographic measurements of the spine were correlated with the clinical outcomes. A total of 62 patients (12.1%) were treated conservatively, 148 (40.8%) with vertebroplasty, 97 (26.7%) with balloon kyphoplasty, and 56 (15.4%) with sky bone expander. We found significant improvements in Visual Analog Score, Oswestry Disability Index, and Short-Form-36 scores for all groups after 1-month follow-up (P<0.05), with the surgical groups demonstrating a greater improvement in pain scores after the first postoperative day (P<0.0001) when compared with the conservative group. The improvements in outcomes in those treated surgically were sustained for up to 2 years with no significant difference (P>0.05) among the surgical groups. We also found significant improvement (P<0.005) in anterior vertebral and kyphotic wedge angle after surgical intervention. We have shown that early surgical intervention allows for quicker pain relief compared with conservative treatment, with similar improvements in anterior vertebral height and kyphotic wedge angle between all 3 groups of surgical management.

Effect of SKy bone expander system by percutaneous osteoplasty in treatment calcaneal fracture

Objective To explore the clinical effect of percutaneous osteoplasty with SKy bone expander system in the treatment of calcaneal fracture.Methods 63 feet of 55 patients with calcaneal fractures were involved in this study.According to Sanders fracture classification including 38 feet of Sanders Ⅱ,18 feet of Sanders Ⅲ,7 feet of Sanders Ⅳ.There were 6 to 16 days interval between the injuries and the surgeries.The patients were treated by percutaneous osteoplasty with the SKy bone expander system.The standard of operation was the satisfaction of reduction and Bohler's and Gissane's angles under X-ray.Results All of 63 feet of 55 patients were followed up for average 22 months.According to the criterion of therapeutic effect,the results were as follows:excellent in 30 cases,good in 26 cases,fair in 7cases,and no poor case.The excellent and good rate was 88.9％.Conclusion Percutaneous osteoplasty with SKy bone expander system in the treatment of calcaneal fracture,especially in reduction and fixation of Sanders type Ⅱ and Sanders type Ⅲ,can recover Bohler's and Gissane's angles,significantly shorten the duration of illness,and has fast recovery and can possess satisfactory curative effect,and it is worth popularizing. Key words: Calcaneus; Fracture fixation; SKy bone expander system

Treatment of osteoporotic compression fracture of thoracic/lumbar vertebrae by kyphoplasty with SKY bone expander system

Objective To investigate prospectively the effectiveness of kyphoplasty with SKY bone expander system in treatment of compression fracture of thoracic/lumbar vertebrae and correction of the deformity. Methods Twenty-five patients with thoracic/lumbar vertebral osteoporotic compression fracture were admitted to our hospital between March 2007 and March 2008, and treated by kyphoplasty with SKY bone expander system. Patient's pain status was rated with Visual Analogue Scale (VAS) score system 1 day before and 1 hour, 48 hours, 6 months, 12 months after surgery. In addition, Rolland-Morris and Oswestry disability questionnaires (RDQ and ODI) were used for survey 1 day before and 1, 6, 12 months after surgery. Pre- and post-operative vertebral heights and Cobb's angles were measured based on the X-ray films and statistically analyzed. Results There were 27 fractured vertebrae in these 25 patients. After SKY kyphoplasty, the Cobb's angles (9.8°±9.76°) were significantly reduced compared with preoperative angles (17.18°±9.35°, P<0.05), and the average improvement rate was 39%. Patients' pain VAS scores were also greatly improved after operation ( P<0.05). Moreover, postoperative RDQ and ODI scores were significantly smaller than preoperative values ( P<0.05). Conclusion Kyphoplasty with SKY bone expander system provides an effective method for treating thoracic/lumbar vertebral osteoporotic compression fracture, with the advantages of small surgical wound and short duration. It can effectively recover the anterior and medial heights of fractured vertebrae (33% and 50%, respectively), reduce the Cobb's angle, quickly alleviate pain and improve patients' quality of life in a relatively short time period.

A comparison between dilator-kyphoplasty and SKy-bone expander kyphoplasty

Objective To compare the clinical results of dilator-kyphoplasty (DKP) and SKy-bone expander kyphoplasty (EKP) . Methods From October 2004 to May 2008, 51 patients with vertebral osteoporotic compression fracture received DKP (29 vertebras) and EKP (27 vertebras). The operation time,bleeding volume, cement injection volume were recorded during operation. The patients' visual analogue scale (VAS) and Oswestry disability index (ODI) scores were evaluated before and after operation. The cement distribution and restoration of vertebral height and Cobb angle were observed post-operation. Results There were no significant differences in operation time or bleeding volume at every vertebra between the 2 groups ( P > 0. 05). The DKP group had a significantly larger cement injection volume of (5.7 ±0. 5) mL than the EKP group [(3.6 ± 1.6) mL] ( P < 0.05). The VAS and ODI scores were decreased significantly in both groups after operation ( P < 0.05) . The vertebral height and Cobb angle were restored in both groups after operation. Nine cases ( 11 vertebras, 40. 7% ) had cement leakage in the EKP group, but one case (one vertebrae, 3.4% ) did in the DKP group. Conclusions Both DKP and EKP are efficacious and safe in the treatment of vertebral compression fractures. The vertebral anterior height, middle vertebral body height, and Cobb angle can be all restored by both procedures. DKP may be better in restoration of the vertebral anterior height, middle vertebral body height, and Cobb angle. DKP may lead to less cement leakage than EKP. Key words: Osteoporosis; Spinal fractures; Thoracic vertebrae; Lumbar vertebrae; Surgical instruments

Clinical application of the Sky bone expander system in treatment of ache from senile vertebral bodies

Objective To investigate the clinical efficacy of percutaneous kyphoplasty using the Sky Bone Expander system in the treatment of ache from senile vertebral bodies.Methods From August 2004 to February 2007,82cases(126 Vertebraes) of ache from senile vertebral bodies underwent pereutaneous kyplasty with sky bone expander system.During the operation the sinqle or double technique was applied and the expansion height was reduced with sky bone expander for bone cement injection.Patients were evaluated with Oswestry disability Index (ODI) and Visual Analogue Sere(VAS).Results Back pain was efectively relieved after the operation in all cases.Extravertebral leakage of bone cement were observed in 5 cases (6 vertebraes),4 cases had not symptome,1 case had die hard neuralqia between ribs,2 cases had toxigenic reaction for hearts.2 postoperative cases with neoplasm metastasis had more pain,but one day after,the pain died away.The postoperative follow-up ranged from 9to 37 months.with an average of 20.5 months.The postoperative ODI(P=0.007) and VAS(P=0.012) had better than preoperative.Conclusion Kyphoplasty using the Sky Bone Expander system is an efecfive and safe treatment for ache from senile vertebral bodies.Sky bone expander system provids siguificant pain relief effect,and can improve the kyphosis deformity and remain vertebral height. Key words: Sky bone expander system; Osteoporesis; Spinal fractures; Neoplasm metastasis

Treatment of old osteoporotic vertebral compression fractures with Sky bone expander percutane-ous kyphoplasty

Objective To discuss the clinical effect of Sky bone expander percutaneous ky-pbeplasty (Sky-PKP) in treatment of old osteoperotic vertebral compression fractures. Methods The study involved 27 patients (27 vertebrae) with old osteoporotic vertebral compression fractures treated by Sky-PKP from March 2005 to June 2007. Normotopia, lateral and dynamia radiographs, CT scanning and MRI were performed preoperatively to verify fluid collection in the vertebral body, vacuum phenomenon and open-close phenomenon. Visual analog scale (VAS), Oswestry disability index (ODI), anterior body height, middle line body height, posterior body height and kyphotic angle changes were measured on a lateral radiograph before and after treatment. Results All patients were followed up for mean 6.2 months, which showed no severe complications. VAS score was decresed from preoperative 7.8 to postop-erative 3.1 and ODI from 65% to 37%. However, The anterior vertebral height and middle line vertebral height were recovered for 4.6 nun and 5.7 mm respectively compared with preoperation. Correction of ky-photic angle was mean 5.6°postoperatively. There was no sitatistical changes in regard to posterior body height before and after operation. Conclusions Sky-PKP is a reasonable procedure for treatment of old osteoporotic vertebral compression fractures under strict control of indications, especially with vacuum phenomenon, open-close phenomenon and fluid collection. While high degree of difficulty in puncturation results in insignificant correction of kyphotic angle and body height. Key words: Spinal fractures; Percutaneoas kyphoplasty; Osteoporosis; Fraetures, old

VESSELPLASTY: A NOVEL CONCEPT OF PERCUTANEOUS TREATMENT FOR STABILIZATION AND HEIGHT RESTORATION OF VERTEBRAL COMPRESSION FRACTURES

Objective: Vertebroplasty, kyphoplasty, VEX-3000, SKy bone expander, arcuplasty, and OptiMesh systems are methods of percutaneous osteoplasty (molding of the bone) to treat symptomatic vertebral compression fractures (VCFs) by injection of bone filler materials (BFMs) such as polymethyl methacrylate (PMMA), other kinds of bone cement, and bone grafts (autografts/allografts) or different kinds of osteoinductive/osteoconductive materials. A common risk in performing the abovementioned techniques is leakage of BFMs. The purpose of this technical consideration of vesselplasty was to review the theory, the surgical technique for stabilization and restoration of the height of VCFs, and the prevention of leakage, using a novel bone filler container (BFC) system. Methods: This novel concept of BFC highlights the Vessel-X™ system (A-Spine Holding, Taipei, Taiwan) as an evolution of the percutaneous osteoplasty technique to stabilize and restore VCFs and to prevent leakage risk. Instead of previously creating a void inside the vertebral body to be filled with BFMs, this system allows the delivery of a nonstretchable BFC into the vertebral body in deflated configuration, to be inflated by injecting viscous BFMs into the BFC, then left as an implant and acting as a vertebral body expander. The volume of the injected BFMs is controlled by a controllable cement delivery (CCD) injector system. The pressure inside the BFC is created by the resistance of the polyethylene terephthalate (PET) container, which is related to the number of layers (one or two layers), the pore size (100 μm), and the container size itself. The optimum pressure needed to lift the endplate is the amount of pressure required to counteract the resistance of the surrounding bone density (fresh or old fractures, young or elderly patients) and the large bending moment due to kyphotic deformity of the spine. The pressure is also related to the amount of BFMs to be injected into a certain size of the BFC. When the pressure is higher than the surrounding bone resistance, BFMs start to penetrate, interdigitate, and stabilize the BFC to the surrounding bone. Conclusions: The vesselplasty technique using the novel concept of BFC allows stabilization and restoration of VCF height, with the added advantages of controlling the volume of the injected BFMs, the pressure inside the BFC, and the leakage risk of BFMs as well as creating a gradual stiffness of BFMs inside the bone from the periphery to the central area.

Preliminary Results for the Treatment of a Pain-Causing Osteoporotic Vertebral Compression Fracture with a Sky Bone Expander

ObjectiveVertebral compression fractures (VCFs) are common complications of osteoporosis. The expansion of VCFs with a Sky Bone Expander is a new procedure which improves kyphotic deformities and decreases pain associated with VCFs. The purpose of this study was to investigate the preliminary results for the treatment of painful osteoporotic VCFs with a Sky Bone Expander.Materials and MethodsTwenty-six patients with pain-causing VCFs were treated with a Sky Bone Expander. This operation involved the percutaneous insertion of the Sky Bone Expander into a fractured vertebral body transpedicularly. Following the expansion, the Sky Bone Expander was contracted and removed, resulting in a cavity to be filled with bone cement. All fractures were analyzed for improvement in sagittal alignment. Clinical complications, pain relief and ambulation status were evaluated 1 day, 1 week, 1 month, and 3 months after the operation.ResultsTwenty-four hours after the operation, all the patients treated experienced some degree of pain relief. In addition, no postoperative neurologic complications were noted. The average operative time was 42.4 ± 15.5 min per vertebra. Moreover, an average cement volume of 3.5 mL (range, 2.5 ± 5.0 mL) was injected per vertebra. The average anterior height was 18.4 ± 5.1 mm preoperatively and 20.5 ± 5.3 mm postoperatively (p < 0.01). Furthermore, the average midline height was 15.5 ± 5.2 mm preoperatively and 18.9 ± 4.0 mm postoperatively (p < 0.01). The Cobb angle improved from 18.5 ± 8.2 degrees preoperatively to 9.2 ± 4.0 degrees postoperatively (p < 0.01). The Visual Anabog Scale scores decreased from 7.7 ± 1.8 points preoperatively to 3.1 ± 2.0, 2.9 ± 1.7, 2.6 ± 1.5 and 2.9 ± 11.3 after 1 day, 1 week, 1 month and 3 months after the operation, respectively. Cement extrusion was observed in four patients without any neurologic symptoms.ConclusionAs a result of this study, we can postulate that the expansion of compressed vetrebra with a Sky Bone Expander is a safe and minimally invasive procedure resulting in the restoration of vertebral body height and the relief of pain associated with VCFs.

The Sky bone expander system in treatment of senile traumatic fractures of vertebral body

目的 探讨Sky膨胀式椎体成形器治疗老年创伤性椎体骨折的疗效和安全性.方法 2004年8月～2006年2月,采用Sky膨胀式椎体成形器行经皮椎体后凸成形术治疗老年由创伤引起的脊柱压缩性骨折23例34椎.所有患者椎体后壁完整,术前均无脊髓和神经根受损的症状和体征.采用经皮穿刺单侧椎弓根置入Sky膨胀式椎体成形器使骨折塌陷椎体复位,用骨水泥进行充填.结果 所有患者术后24 h内疼痛症状明显缓解或消失,术后1 d可下地行走,3 d出院.术后第2天常规行X线复查,2例3个椎体出现骨水泥少许渗漏,未见神经压迫症状.手术前、后骨折椎体前缘的平均高度分别为(18.34±3.25)mm和(20.51±1.34)mm,差异有统计学意义(P＜0.05);中线的平均高度分别为(14.40±2.56)mm和(19.66±1.28)mm,差异有统计学意义(P＜0.05);后缘的平均高度分别为(23.78±1.89)mm和(24.57±2.03)mm,差异无统计学意义(P＞0.05),均提示伤椎前中部高度恢复明显.后凸畸形纠正范围13°～26°,平均19°.23例随访17～36个月,平均24.3个月,未诉明显疼痛,X线片示椎体高度未见明显丢失.未出现严重并发症.患者术前、术后第3天、随访12个月时的平均VAS评分分别为7.9分、3.1分、2.8分,后两者与术前比较差异均有统计学意义(P＜0.05).结论 Sky膨胀式椎体成形器治疗性老年创伤性椎体压缩骨折,能迅速缓解疼痛,恢复椎体高度。

Results, experience and technical points learnt with use of the SKy Bone Expander kyphoplasty system for osteoporotic vertebral compression fractures: a prospective study of 40 patients with a minimum of 12 months of follow-up

To describe our centre's results, experience and technical points learnt with the SKy Bone Expander System for osteoporotic vertebral compression fractures (VCFs). Forty consecutive patients with painful single level T12 or L1 osteoporotic VCF who had failed conservative management for more than 3 months had 40 single level SKy Bone Expander kyphoplasties performed. Using local anaesthesia with patients in a prone, hyper-lordotic position, a unilateral, percutaneous, intra-pedicular approach was employed. Once correctly positioned, the SKy Bone Expander was expanded, creating a void. It was subsequently contracted, removed and bone cement injected. Pre-kyphoplasty and 12-month post-kyphoplasty radiological and functional outcomes were recorded. Statistical analysis was by Wilcoxon Signed Ranks Test. Median percentage increase in anterior, middle and posterior vertebral body heights at 12-month post-operative was 51.25% [inter-quartile range (IQR) 17.21-93.22], 52.29% (IQR 26.50-126.17) and 9.84% (IQR 4.94-19.26) respectively, while median percentage decrease in kyphotic angle was 30.77% (IQR 17.06-46.61). There was no significant vertebral body correction loss at 12-month post-operative. Visual analogue score, North American Spine Society and Short Form-36 scores for physical functioning and bodily pain scores improved by medians of 5.0 (IQR 3.0-8.0), 1.45 (IQR 0.68-2.90), 20.5 (IQR 0.0-40.8) and 10.0 (IQR 0.0-20.0) respectively. All P-values were <0.001. There were eight adjacent/remote level VCFs, three cases of cement extravasation and one case of the SKy Bone Expander being unable to be contracted and withdrawn from the vertebral body. It was left in situ. This is the first reported incidence of such a complication. The SKy Bone Expander System appears to be a viable alternative to balloon tamp kyphoplasty. Important technical considerations include proper device positioning within the vertebral body before expansion, single use of devices, familiarity with salvage procedure and injection of bone cement under close image intensifier guidance to prevent cement extravasation.

Preliminary clinical outcomes of percutaneous kyphoplasty with Sky-bone expander

Percutaneous kyphoplasty (PKP) using balloon expander has been proved to be effective in the treatment of painful vertebral compression fractures. Recently, Sky-bone expander, an alternative bone expander for PKP has been developed. The purpose of this study was to show our preliminary clinical outcomes of PKP with Sky-bone expander. PKP with Sky-bone expander was performed in 25 patients (30 vertebrae). The operation time, bleeding volume, cement volume injected were recorded. The pain and functional activities of the patients before and after the operation were compared using Wilcoxon signed-rank test. The cement distribution in the vertebrae, vertebral height restoration, and kyphosis correction after the procedure were evaluated by radiography. The pre- and post-operative absolute values of the vertebral height and kyphotic angle were compared by paired-sample t test. All the patients were followed up by telephone or clinic consulting after being discharged from our hospital. The procedure was performed successfully in all the patients. Bipedicular injection was used in 2 of the patients, and unipedicular injection was made in the others. The operation time ranged from 25 to 120 minutes (45 minutes per vertebra on average). The average bleeding volume was about 20 ml. Polymethylmethacrylate 1.5-5.0 ml (mean, (3.15+/-0.78) ml) was injected through each pedicle into all the patients except one, who received calcium sulphate 3.5 ml instead. The patients were followed up for 12-15 months (13.5 months on average). The mean visual analogue scale (VAS) score, Oswestry Disability Index, anterior, midline, and posterior vertebral height, and kyphotic angle of the patients were improved significantly at the end of the follow-up compared with those before the operation. (2.5+/-1.3, 35.1%, (20.94+/-6.15) mm, (20.26+/-4.59) mm, (26.72+/-3.49) mm, and 8.2 degrees vs. 8.5+/-1.9, 61.2%, (19.11+/-6.72) mm, (15.88+/-5.73) mm, (25.78+/-3.67) mm, and 17.3 degrees; all P<0.05). The cement distribution with unipedicular injection was mostly limited within the injection site in the vertebral body. Cement extravasation was seen at ten levels (33.3%). PKP with Sky-bone expander is an effective and relatively safe alternative to the PKP using balloon expander. It can relieve pain, improve physical function, and restore the height of the collapsed vertebrae, but the cement extravasation is unsolved.

“SKyphoplasty”: A Single Institution's Initial Experience

The treatment of painful compression fractures has been revolutionized by vertebroplasty and kyphoplasty, two recently developed techniques that continue to evolve. This article describes a new device for the performance of kyphoplasty that uses a polymer device rather than a balloon to create a void in the bone. In nine consecutive patients, kyphoplasty was performed at 12 vertebral levels with osteoporotic compression with use of the new SKy bone expander polymer device. The device was successful in creating a void in the bone at all levels. The procedure was also effective in alleviating pain from compression fractures. There were no technical failures or complications. The SKy bone expander polymer device is effective and safe for the performance of kyphoplasty to alleviate pain from vertebral compression fractures.

The Sky bone expander system in treatment of osteoporotic compression fractures of vertebral body

目的 探讨膨胀式椎体成形器 (Sky)在骨质疏松性椎体压缩性骨折治疗中的手术方法、临床效果、适应证及其技术优势.方法回顾分析采用 Sky治疗 74例( 87个椎体)骨质疏松性椎体压缩骨折患者,其中 16例附加后路 USS固定融合.按照 Genant分级 :一级 29个椎体,二级 41个椎体,三级 17个椎体.新鲜骨折 46例,陈旧性骨折 28例.术前 VAS评分 8.7分.结果术后平均随访 8.6个月,所有患者疼痛消失或明显减轻,术后第 3天的平均 VAS评分为 1.4分 (P< 0.01).无严重并发症发生,脊柱后凸角由术前平均 20.9°恢复为平均 12.4°,疗效满意.结论 Sky椎体成形术对新鲜和陈旧性椎体压缩性骨折均适用,该方法安全有效,并发症少,具有重要的应用价值。

4:23 35. Vertebral compression fracture reconstruction: a multi-center study

BACKGROUND CONTEXT: A novel expandable device was used to reconstruct fractured vertebral bodies by means of a minimally invasive technique. The SKy Bone Expander System is a 4-mm-diameter polymer tube that following axial pressure, radially expands up to 16 mm in diameter. The concept enables percutaneous positioning of the device in its reduced form under local or general anesthesia, and its contraction and removal once vertebral reconstruction is achieved. The device creates a defined cavity, which enables paste-like bone cement injection instead of liquiform injection with standard vertebroplasty techniques.