A prospective, international, randomized, noninferiority study comparing an titanium implantable vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study)

Noriega, David C.; Marcia, Stefano; Theumann, Nicolas; Blondel, Benjamin; Simon, A.; Hassel, Frank; Maestretti, Gianluca; Petit, Antoine; Weidle, Patrick A.; González, Andrés; Kaya, J.-M.; Touta, Adamou; Fuentès, S.; Pflugmacher, Robert

doi:10.1016/j.spinee.2020.08.021

Cited by 16 publications

(19 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A prospective multicenter randomized trial of 141 patients comparing SpineJack and BKP (SAKOS) [23] confirmed non-inferiority of the SpineJack to BKP at 6-and 12-month period. SpineJack group was superior to BKP group in VB height restoration at 6-and 12-month period and in pain relief at 1-and 6-month period after surgery.…”

Section: Clinical Outcomementioning

confidence: 97%

Vertebral augmentation with spinal implants: third-generation vertebroplasty

Manz

Georgy

Beall³

et al. 2020

Neuroradiology

View full text Add to dashboard Cite

This article is to review the different types of vertebral augmentation implants recently becoming available for the treatment of benign and malignant spinal compression fractures. After a detailed description of the augmentation implants, we review the available clinical data. We will conclude with a summary of the advantages and disadvantages of vertebral implants and how they can affect the future treatment options of compression fractures. Keywords Vertebroplasty . Kyphoplasty . Compression fractures . Implants Abbreviations BKP Balloon kyphoplasty VB Vertebral body VP Vertebroplasty VAS Visual analog score ODS Ostwestery disability score VBS Vertebral body stent The treatment of vertebral compression fractures is commonly performed using vertebroplasty or kyphoplasty techniques. Many variations of both techniques exist including different types of needles, balloons, and channel creating devices as well as different types of cements. Regardless of the technique used, excellent pain relief and a very low complication rate have been reported. Background and biomechanicsMore specifically, multiple new devices have been recently introduced for vertebral augmentation, the so-called third Key Points 1. Describe different types of vertebral implants available for treatment of spinal compression fractures 2. Outline published clinical data for each implant 3. Summarize the pros and cons of this new technique, the so called third generation vertebroplasty 4. Outline future role in treatment of traumatic and malignant lesions * Bassem A. Georgy

show abstract

Section: Clinical Outcomementioning

confidence: 97%

Vertebral augmentation with spinal implants: third-generation vertebroplasty

Manz

Georgy

Beall³

et al. 2020

Neuroradiology

View full text Add to dashboard Cite

show abstract

“…5 In 2019, a prospective, international, randomized study compared an implantable titanium vertebral augmentation device versus BKP in the reduction of vertebral compression fractures and found non-inferiority of the titanium augmentation device with an excellent risk/bene t pro le for results up to 12 months. 14 Furthermore, in vitro biomechanical cadaver studies demonstrated height restoration was signi cantly better in the VS (SpineJack) group compared with the BKP group. 15 The clinical implications include a better restoration of the sagittal balance of the spine and a reduction of the kyphotic deformity.…”

Section: Surgical Segment Vertebra Stiffnessmentioning

confidence: 99%

Biomechanical Comparison of Vertbroplasty, Kyphoplasty, Vertebrae Stent for Osteoporotic Vertebral Compression Fractures -A Finite Element Analysis

Liao

Chen

Lin

et al. 2021

Preprint

View full text Add to dashboard Cite

Vertebroplasty (VP), balloon kyphoplasty (BKP), and vertebral stent (VS) are usually used for osteoporotic compression fracture. However, these procedures may pose risks of secondary adjacent level fractures. This study simulates finite element models of osteoporotic compression fractures treated with VP, BKP, and VS. Vertebral resection method was used to simulate vertebra fracture with Young’s modulus set at 70 MPa to replicate osteoporosis. A compressive force of 1000N was applied on the T11 vertebra while the L1 vertebra were fully constrained as boundary condition. Moment loadings of 4.2 N-m in flexion, 1.0 N-m in extension, 2.6 N-m in lateral bending, and 3.4 N-m in axial rotation were applied. The VS model had the highest von Mises stresses on the bone cement under all different loading conditions (flexion/5.91 Mpa; extension/3.74 Mpa; lateral bending/3.12 Mpa; axial rotation/3.54 Mpa). The stress distribution and maximum von Mises stresses of the adjacent segments, T11 inferior endplate and L1 superior endplate, showed no significant difference among three surgical models. The postoperative T12 stiffness for VP, BKP, and VS are 2898.48 N/mm, 4123.18 N/mm, and 4690.34 N/mm, respectively. VS is the most effective surgical method to maintain vertebral body height without significantly increasing the risks of adjacent fracture.

show abstract

“…Recent literature has defined the technical success of VA as restoration of vertebral body height, reduction of kyphotic angle, reduction of fracture fragments, and restoration of spine sagittal balance. [3][4][5] Interventional and musculoskeletal radiologists now have not only VP and BKP within their armamentarium, but also mechanical implant-assisted augmentation via the SpineJack (SJ) (Stryker, Kalamazoo, MI), Kiva (KV) (IZI-Medical Ownings Mills, MD), or V-STRUT (VS) (Hyprevention, Pessac, France). These new devices have expanded the indications for treatment and improved outcomes but require operators to be prepared to adapt their approach based on interval fracture progression, vertebral anatomy, and bone quality upon placement of initial cannula.…”

Section: Augmentation Techniquesmentioning

confidence: 99%

“…Patients have fewer adjacent-level fractures, superior height restoration, potentially better pain relief, and greater potential mortality benefit over VP and nonsurgical management. 3,4 SJ is a titanium implantable device that can deliver up to 1,000 N of lifting force. The Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques (SAKOS) trial demonstrated that using SJ results in reduced rates of adjacent-level fractures and superior midline vertebral body height restoration, compared with using BKP.…”

Section: Augmentation Techniquesmentioning

confidence: 99%

“…2 Each technical advance has sought to achieve clinically significant pain reduction and functional improve-ment, with the ultimate goal of height restoration, kyphotic angle reduction, reduction in subsequent fractures, and preservation of the normal sagittal balance of the spine. [3][4][5] Fragility fractures remain a major and growing worldwide public health issue with morbidity, mortality, and annual U.S. health care expenditures in the tens of billions of dollars. Approximately 1.5 million osteoporotic fractures occur annually, with vertebral compression fractures (VCFs) the most common, and they affect as many as 1 in 5 men and women > 50 years of age in the United States.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Vertebroplasty, Kyphoplasty, and Implant-Based Mechanical Vertebral Augmentation

Key

Symanski

Scheidt

et al. 2021

Semin Musculoskelet Radiol

View full text Add to dashboard Cite

Vertebral compression fractures are a global public health issue with a quantifiable negative impact on patient morbidity and mortality. The contemporary approach to the treatment of osteoporotic fragility fractures has moved beyond first-line nonsurgical management. An improved understanding of biomechanical forces, consequential morbidity and mortality, and the drive to reduce opioid use has resulted in multidisciplinary treatment algorithms and significant advances in augmentation techniques. This review will inform musculoskeletal radiologists, interventionalists, and minimally invasive spine surgeons on the proper work-up of patients, imaging features differentiating benign and malignant pathologic fractures, high-risk fracture morphologies, and new mechanical augmentation device options, and it describes the appropriate selection of devices, complications, outcomes, and future trends.

show abstract

A prospective, international, randomized, noninferiority study comparing an titanium implantable vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study)

Cited by 16 publications

References 4 publications

Vertebral augmentation with spinal implants: third-generation vertebroplasty

Vertebral augmentation with spinal implants: third-generation vertebroplasty

Biomechanical Comparison of Vertbroplasty, Kyphoplasty, Vertebrae Stent for Osteoporotic Vertebral Compression Fractures -A Finite Element Analysis

Vertebroplasty, Kyphoplasty, and Implant-Based Mechanical Vertebral Augmentation

Contact Info

Product

Resources

About