Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study

Noriega, David; Rodrίguez-Monsalve, F.; Ramajo, Rubén Hernández; Sánchez-Lite, Israel; Toribio, Borja; Ardura, Francisco

doi:10.1007/s00198-018-4773-5

Cited by 49 publications

(55 citation statements)

References 35 publications

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“…The thoracolumbar junction is also found to be more vulnerable to gradual height decrease and progressive deformity despite either VA or BKP [12]. Recent experience with using bilateral titanium implants, the SpineJack R system (Stryker, Kalamazoo, Michigan, USA), that maintain the correction supplemented by use of lesser amounts of bone cement is a new option in these cases since the SpineJack (SJ) has been shown to both maintain the correction over one year studies and more importantly, has significant less incidence of adjacent level fractures [13]. This case highlights the use of the SJ implants for an L1 fracture because of all the above factors.…”

Section: Introductionmentioning

confidence: 99%

Treatment of a High-risk Thoracolumbar Compression Fracture Using Bilateral Expandable Titanium SpineJack Implants

Hartman¹,

Granville²,

Jacobson³

2019

Cureus

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In this case, an 80-year-old active patient developed an acute osteoporotic fracture after a fall at L1 above a previous interlaminar implant at L4-5 for stenosis with neurogenic claudication. Radiologic studies found both intra-discal and intra-vertebral vacuum clefts that are highly correlated with instability and progressive kyphosis. Long-term experience with kyphoplasty has shown that acute and subacute fractures can often be re-expanded; however, over three months to one year, the correction is frequently lost and the vertebral height continues to decrease leading to increased risk of both continued deformity and especially adjacent level fractures. The use of newly available titanium intra-vertebral implants combined with bone cement restores and maintains vertebral height and correction of deformities. Long-term studies also demonstrate a reduced risk of adjacent level fractures compared to balloon kyphoplasty. Using vertebral body implants that remain in place within the fractured vertebral body the initial height correction can be better maintained leading to less adjacent level fractures.

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Section: Introductionmentioning

confidence: 99%

Treatment of a High-risk Thoracolumbar Compression Fracture Using Bilateral Expandable Titanium SpineJack Implants

Hartman¹,

Granville²,

Jacobson³

2019

Cureus

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“…PVP or PKP has been reported as a safe and effective treatment for OVCF 3,4,12 . These traditional cement augmentation techniques have been used for augmentation of the fractured vertebra with the vertebral endplate and disc untreated.…”

Section: Discussionmentioning

confidence: 99%

Percutaneous intervertebral bridging cementoplasty for adjacent multilevel osteoporotic thoracolumbar fractures with vertebral endplate-disc complex injury: technical note

Wang

Duan

Yang

et al. 2020

Sci Rep

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this paper describes a minimally invasive technique of percutaneous intervertebral bridging cementoplasty (piBc) to augment the fractured vertebrae and immobilize the intervertebral space with endplate-disc complex injury simultaneously. thirty-two patients with adjacent multilevel osteoporotic thoracolumbar fractures (AMotLfs) and vertebral endplate-disc complex injury (eDci) treated by piBc were retrospectively reviewed. the piBc technique was a combination of puncture, balloon expansion and bridging cementoplasty. the clinical and radiological assessments were reviewed. The operation time was 82.8 ± 32.5 min, and blood loss was 76.9 ± 31.7 mL. A cement bridge was connected between the two fractured vertebrae across the injured intervertebral space. VAS at three time points including pre-operation, post-operation 1 day and final follow-up was 6.9 ± 0.9, 2.9 ± 0.8 and 1.7 ± 0.8, respectively; ODI at three time points was (71.1 ± 7.8)%, (18.4 ± 5.7)%, and (10.3 ± 5.7)%, respectively; Cobb angle at three time points was 46.0° ± 10.4°, 25.9° ± 8.5°, and 27.5° ± 7.1°, respectively. Compared with pre-operation, VAS, ODI and Cobb angle were significantly improved at post-operation 1 day and final follow-up (P < 0.05). Clinical asymptomatic cement leakage was observed in thirteen patients. no vessel or neurological injury was observed. piBc may be an alternative way of treatment for AMotLfs with eDci. the technique is a minimally invasive surgery to augment the fractured vertebrae and immobilize the injured intervertebral space simultaneously. Osteoporotic vertebral fracture is an increasing common spinal disorder among the elderly patients. Thoracolumbar vertebrae are frequently involved segments and they can cause disabling pain and kyphotic deformity 1. Although conservative pain management is recommended for some patients, minimally invasive vertebral augmentation is generally advocated for symptomatic osteoporotic vertebral fracture 2,3. Patients with symptomatic acute or subacute osteoporotic vertebral compression fracture (OVCF) are often considered potential candidates for treatment with vertebral augmentation. Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are the preferred augmentation techniques which provided rapid pain relief and sustained improvement of physical function 3,4. Furthermore, PKP has advantages of correcting the kyphotic deformity and restoring the height of the fractured vertebrae. However, some OVCFs are characterized not only by vertebral compression fractures, but also by vertebral endplate-disc complex injury (EDCI) 5. Current treatment strategies, such as vertebroplasty and kyphoplasty, are aimed only at stabilizing these painful vertebral fractures. EDCI cannot be treated by traditional augmentation techniques. Consequently, EDCI may account for cement leakage into the disc and persistent back pain after vertebral augmentation. In addition, EDCI may be labeled as new adjacent levels fracture or instability 6 .

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“…However, independent studies on intradiscal pressure demonstrate that there is significant reduction in pressure in the disc space above an untreated compression fracture which may lead to loss of mechanical support by the intervening disc between the already deformed fractured vertebra and the superior adjacent often osteoporotic vertebra [15,19]. Pressure measurements within the adjacent disc before and after expansion of the SJ support this theory, with post-implant measurements showing return to more normalized pressures [17,19-20]. This raises a possible additional bio-mechanical explanation for the significant reduction in adjacent level osteoporotic fractures as the restoration of disc pressure to normal provides better support to the adjacent vertebra and makes it less vulnerable to both compression and sheer forces [20].…”

Section: Discussionmentioning

confidence: 99%

“…Pressure measurements within the adjacent disc before and after expansion of the SJ support this theory, with post-implant measurements showing return to more normalized pressures [17,19-20]. This raises a possible additional bio-mechanical explanation for the significant reduction in adjacent level osteoporotic fractures as the restoration of disc pressure to normal provides better support to the adjacent vertebra and makes it less vulnerable to both compression and sheer forces [20].…”

Section: Discussionmentioning

confidence: 99%

Re-expansion of Osteoporotic Compression Fractures Using Bilateral SpineJack Implants: Early Clinical Experience and Biomechanical Considerations

Jacobson

Nenov

Duong

2019

Cureus

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Thoraco-lumbar osteoporotic compression fractures have a higher incidence of continued collapse with development of deformity and progression to vertebra plana when untreated and even after vertebral augmentation (VA) or balloon kyphoplasty (BKP). Even when there is the restoration of height and improvement in angulation, multiple long-term follow-up series have repeatedly documented that over time, many patients lose the initial height correction and in a smaller group the vertebral body re-collapses leading to the development of progressive deformity with an increased risk for adjacent level fractures. At first, larger balloons and more cement were used to try and avoid these problems, but it did not reduce the risk of adjacent fractures. Several procedures were developed to place various types of intervertebral implants combined with bone cement to maintain the initial height correction. Initial studies with these implants showed a reduction in adjacent level fractures but the systems did not proceed to market. The SpineJack R (SJ) system (Stryker Corp, Kalamazoo, MI), consisting of bilateral expandable titanium implants supplemented with bone cement, was first used approximately 10 years ago in Europe and recently gained FDA approval in the United States. This system provides more symmetric and balanced lateral and anterior support and is effective with lesser amounts of bone cement compared to BKP. Follow-up studies have documented that there is equal or better pain control, with better long-term results based both on maintaining vertebral height restoration and deformity correction. Most importantly, statistically it clearly reduces the risk of adjacent level fractures by at least 60%. The biomechanical effects of intravertebral implants for osteoporotic fractures in regard to the risk of adjacent level fractures and preliminary experience with the use of the SJ is reviewed.

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Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study

Cited by 49 publications

References 35 publications

Treatment of a High-risk Thoracolumbar Compression Fracture Using Bilateral Expandable Titanium SpineJack Implants

Treatment of a High-risk Thoracolumbar Compression Fracture Using Bilateral Expandable Titanium SpineJack Implants

Percutaneous intervertebral bridging cementoplasty for adjacent multilevel osteoporotic thoracolumbar fractures with vertebral endplate-disc complex injury: technical note

Re-expansion of Osteoporotic Compression Fractures Using Bilateral SpineJack Implants: Early Clinical Experience and Biomechanical Considerations

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