Is Kiva implant advantageous to balloon kyphoplasty in treating osteolytic metastasis to the spine? Comparison of 2 percutaneous minimal invasive spine techniques: a prospective randomized controlled short-term study.

STUDY DESIGN: Prospective, parallel-group, controlled, comparative randomized study. OBJECTIVE: To compare cement leakage rate and efficacy for vertebral body restoration of balloon kyphoplasty (BK) versus Kiva novel implant with polymethylmethacrylate (PMMA) for treating osteolytic vertebral body metastasis. SUMMARY OF BACKGROUND DATA: Minimally invasively vertebral augmentation techniques with PMMA are mostly performed for treating osteoporotic compression fractures. The Kiva implant with PMMA offers better vertebral body restoration and less PMMA leakage than BK in osteoporotic fractures. No previous study compared leakage rate and efficacy for vertebral body restoration in traditional BK and Kiva with PMMA in osteolytic vertebral body metastases. METHODS: This study examined 23 patients (71 ± 13 yr) with 41 osteolytic vertebral bodies, who received Kiva with low viscosity PMMA and 24 patients (70 ± 11 yr) with 43 vertebral body osteolyses, who were reinforced with BK and high viscosity PMMA. All osteolyses were graded as Tomita 1 to 3. Anterior vertebral body height ratio (AVBHr), posterior vertebral body height ratio (PVBHr), and middle vertebral body height ratio (MVBHr), Gardner kyphotic deformity, PMMA leakage and were measured and compared between the groups. Visual analogue scale and Oswestry Disability Index were used for functional outcome evaluation. RESULTS: No patient survived after 3 months. Asymptomatic PMMA leakage occurred in 4 (9.3%) vertebrae in the BK group solely (2 to the spinal canal, in Tomita grade 3 osteolysis) Anterior, posterior and middle vertebral body height ratio, Gardner angle improved insignificantly in both groups. Visual anlogue scale and Oswestry Disability Index improved postoperatively similarly in both groups (P < 0.001). CONCLUSION: BK and Kiva provided equally significant spinal pain relief in patients with cancer with osteolytic metastasis. The absence of cement leakage in the Kiva group and absence of neurological complication in the BK group leakages reflects the safety of both augmentation techniques even in significant osteolysis. The lack of cement leakage in the Kiva cases, although low viscosity PMMA was used, increases this implant safety in augmenting severely destructed thoracolumbar vertebrae and sacrum from osteolytic metastasis. LEVEL OF EVIDENCE: 1.

Transpedicular vertebral body augmentation reinforced with pedicle screw fixation in fresh traumatic A2 and A3 lumbar fractures: comparison between two devices and two bone cements.

This retrospective study compares efficacy and safety of balloon kyphoplasty (BK) with calcium phosphate (Group A) versus KIVA implant with PMMA (Group B) reinforced with three vertebrae pedicle screw constructs for A2 and A3 single fresh non-osteoporotic lumbar (L1-L4) fractures in 38 consecutive age- and diagnosis-matched patient populations. Extracanal leakage of both low-viscosity PMMA and calcium phosphate (CP) as well as the following roentgenographic parameters: segmental kyphosis (SKA), anterior (AVBHr) and posterior (PVBHr) vertebral body height ratio, spinal canal encroachment (SCE) clearance, and functional outcome measures: VAS and SF-36, were recorded and compared between the two groups. All patients in both groups were followed for a minimum 26 (Group A) and 25 (Group B) months. Extracanal CP and PMMA leakage was observed in four (18 %) and three (15 %) vertebrae/patients of group A and B, respectively. Hybrid fixation improved AVBHr, SKA, SCE, but PVBHr only in group B. VAS and SF-36 improved postoperatively in the patients of both groups. Short-segment construct with the novel KIVA implant restored better than BK-fractured lumbar vertebral body, but this had no impact in functional outcome. Since there was no leakage difference between PMMA and calcium phosphate and no short-term adverse related to PMMA use were observed, we advice the use of PMMA in fresh traumatic lumbar fractures.

PMMA embolization to the left dorsal foot artery during percutaneous vertebroplasty for spinal metastases.

PURPOSE: Distal arterial embolization to the foot with PMMA during vertebral augmentation has not been previously reported. We report a rare case of distal PMMA embolization to the dorsal foot artery during ipsilateral percutaneous lumbar vertebral augmentation in a patient with spinal osteolytic metastases. METHODS: A 68-year-old woman was admitted because of severe disabling low back pain. Plain roentgenograms, MRI and CT-scan revealed osteolysis in the L4 and L5 vertebral bodies with prevertebral soft tissue involvement. Percutaneous vertebroplasty with PMMA was performed in L2 to L5 vertebrae under general anesthesia. Intraoperatively, leakage into the segmental vessels L3 and L5 was observed. RESULT: Four hours after the procedure the clinical diagnosis of acute ischemia and drop foot on the left was made. CT-angiography justified linear cement leakage in the course of the left third lumbar vein and fifth lumbar artery, and to the ipsilateral common iliac artery. The patient was treated with low molecular heparin and the ischemia resolved without further sequelae 1 week postoperatively. CONCLUSION: PMMA leakage is a complication associated with vertebroplasty and kyphoplasty. Although the outcome of the PMMA embolization to the vessels resolved without sequelae, in our case spine surgeons and interventional radiologists should be aware on this rare complication in patients with osteolytic vertebral metastases even when contemporary cement containment techniques are used.

Less invasive reduction and fusion of fresh A2 and A 3 traumatic L 1-L 4 fractures with a novel vertebral body augmentation implant and short pedicle screw fixation and fusion.

The aim of this clinical study was to report on the efficacy in reduction and safety in PMMA leakage of a novel vertebral augmentation technique with PEEK and PMMA, together with pedicle screws in the treatment of fresh vertebral fractures in young adults. Twenty consecutive young adults aged 45 ± 11 years with fresh burst A3/AO or severely compressed A2/AO fractures underwent via a less invasive posterior approach one-staged reduction with a novel augmentation implant and PMMA plus 3-vertebrae pedicle screw fixation and fusion. Radiologic parameters as segmental kyphosis (SKA), anterior (AVBHr) and posterior vertebral body height ratio (PVBHr), spinal canal encroachment (SCE), cement leakage and functional parameters as VAS, SF-36 were measured pre- and post-operatively. Hybrid construct restored AVBHr (P < 0.000), PVBHr (P = 0.02), SKA (P = 0.015), SCE (P = 0.002) without loss of correction at an average follow-up of 17 months. PMMA leakage occurred in 3 patients (3 vertebrae) either anteriorly to the fractured vertebral body or to the adjacent disc, but in no case to the spinal canal. Two pedicle screws were malpositioned (one medially, one laterally to the pedicle at the fracture level) without neurologic sequelae. Solid posterolateral spinal fusion occurred 8-10 months post-operatively. Pre-operative VAS and SF-36 scores improved post-operatively significantly. This study showed that this novel vertebral augmentation technique using PEEK implant and PMMA reduces and stabilizes via less invasive technique A2 and A3 vertebral fractures without loss of correction and leakage to the spinal canal.

Balloon kyphoplasty versus KIVA vertebral augmentation--comparison of 2 techniques for osteoporotic vertebral body fractures: a prospective randomized study.

STUDY DESIGN: Prospective, parallel-group, controlled comparative randomized study. OBJECTIVE: This study compares the efficacy in sagittal vertebral height and wedge deformity restoration, polymethylmethacrylate cement leakage safety, and functional outcome of balloon kyphoplasty (BK) versus KIVA (a novel vertebral augmentation technique) implant for the augmentation of fresh osteoporotic vertebral body fractures. SUMMARY OF BACKGROUND DATA: Minimally invasive vertebral augmentation procedures have been widely used to treat vertebral compression fractures caused by osteoporosis. The results of these trials are encouraging in augmenting the vertebra and reducing the wedge deformity. However, after BK, polymethylmethacrylate leakage remains common after A3.1 AO type fractures, with a frequency per vertebra into the epidural space up to 9.8% but less common (0.03%-5.6%) in A1.1 AO type fracture. KIVA is a novel percutaneous uniportal vertebral augmentation device that is designed to restore the vertebral body and reduce polymethylmethacrylate leakage. METHODS: From a total 190 patients with osteoporotic fractures who were initially enrolled in this prospective randomized study, 10 patients were excluded (5 met exclusion criteria, 5 with evidence of metastasis). This study examined 82 patients (69 ± 11 yr) with 133 fractures who received KIVA and 86 patients (72 ± 9 yr) with 122 fractures that were reinforced with BK. Anterior (anterior vertebral body height ratio [AVBHr]), midline (midline vertebral body height ratio [MVBHr]), and posterior (posterior vertebral body height ratio [PVBHr]) vertebral body height ratio and Gardner segmental vertebral wedge deformity were measured preoperatively to postoperatively. New fractures were recorded at the final observation. The baseline anthropometric and roentgenographic parameters did not differ between the 2 groups. Any cement leakage was examined on plain roentgenograms and computed tomographic scan. All patients were followed for an average of 14 months (range, 13-15 mo) postoperatively. RESULTS.: At the final observation, both KIVA and BK restored significantly AVBHr, PVBHr, and MVBHr. However, only KIVA device reduced significantly the Gardner angle (P = 0.002). Residual kyphosis of more than 5° was measured significantly more (P < 0.001) in the BK than in KIVA spines. KIVA showed significantly lower (3%, χ2, P ≤ 0.05) leakage) [corrected] (paravertebral, intradiscal) rate per vertebra than BK (0.098%) in which because of intracanal leakage 2 patients developed acute paraplegia and were reoperated in emergency. New fracture rate was similar in both groups. Back pain scores (visual analogue scale), 36-Item Short Form Health Survey (Physical Function and Mental Health domains), and Oswestry Disability Index scores improved significantly in the patients of both groups. CONCLUSION: Both KIVA and BK restored in short-term similarly vertebral body height, but only KIVA restored vertebral body wedge deformity. KIVA was followed by significantly lower and harmless always extracanal leakage rate than BK. Longer observation is needed to show whether these radiological changes have any functional impact.