Cementless Fixation of Osteoporotic VCFs Using Titanium Mesh Implants (OsseoFix): Preliminary Results

Abstract

Introduction. Vertebral compression fractures (VCFs) affect 20% of people over the age of 70 with increasing incidence. Kypho-/vertebroplasty as standard operative procedures are associated with limitations like cement leakage, limited reduction capabilities, and risk for adjacent fractures. To address these shortcomings, we introduce a new minimal invasive cementless VCF fixation technique. Methods. Four patients (72.3 years, range 70–76) with VCFs type AO/Müller A1.3 and concomitant osteoporosis were treated by minimal invasive transpedicular placement of two intervertebral mesh cages for fracture reduction and maintenance. Follow-up included functional/radiological assessment and clinical scores and averaged 27.7 months (24–28). Results. Endplate reduction was achieved in all cases (mean surgery time: 28.5 minutes). Kyphotic (KA) and Cobb angle revealed considerable improvements postoperatively (KA 14.5° to 10.7°/Cobb 10.1° to 8.3°). Slight loss of vertebral reduction (KA: 12.6°) and segment rekyphosis (Cobb: 10.7°) were observed for final follow-up. Pain improved from 8.8 to 2.8 (visual analogue scale). All cases showed signs of bony healing. No perioperative complications and no adjacent fractures occurred. Conclusion. Preliminary results in a small, selected patient collective indicate the ability of bony healing for osteoporotic VCFs. Cementless fixation using intravertebral titanium mesh cages revealed substantial pain relief, adequate reduction, and reduction maintenance without complications. Trial registration number is DRKS00005657, German Clinical Trials Register (DKRS).

Percutaneous stabilization of lumbar spine: a literature review and new options in treating spine pain

“…As an alternative to BKP, VA mechanical devices were introduced in the past few years, [63][64][65][66][67][68][69][70][71] in order to reach the best long-term vertebral height restoration. In fact, clinical experience has demonstrated a potential limitation of BKP with loss of restored height after balloon deflation due to vertebral elastic recoil.…”

“…To the best of our knowledge, four VA systems were described in literature: the VerteLift® (Spine Align Medical Inc., San Jose, CA) 64 ( Figure 3), a nitinol cage; the OsseoFix® (Alphatec Spine Inc., Carlsbad, CA) [69][70][71] (Figure 4), a titanium self expandable mesh cage; the Vertebral Body Stenting® (Synthes, Soletta, Switzerland) ( Figure 5), 66,67 a titanium balloon-expandable stent; and the Spine Jack® (Vexim, Balma, France), 74 a titanium endovertebral jack ( Figure 6). Procedures can be performed in an operating room equipped with a C arm or in an angiography room.…”

“…Then, cement injection could be performed by means of dedicated fillers, but some authors described the implant of the mesh cages without PMMA injection. 69 The vertebral body stenting device represents an evolution of BKP, having a balloon expandable titanium stent that can be delivered with balloon inflation. 63,66,67 Through the working cannula, a metallic drill can be used to model the trabecular bone such as other osteotomy cannula to lead the insertion of the metallic implant without problems.…”

Third-generation percutaneous vertebral augmentation systems

“…It is made of a titanium mesh which expands into the vertebral body with the aim of reducing the vertebral fractures and decreasing the kyphotic deformity by compacting the surrounding trabecular bone (31 (31,32). This device is inserted into the vertebral body, targeting its tip to the anterior third of the vertebral body, and subsequently expanding the screw handle.…”

“…Because the trabecular bone surrounding the devices is finally compacted, this system is also able to reduce the risk of cement leakage (33). For these reasons, OsseoFix ® provides both immediate and long-term effectiveness in reducing pain and kyphotic deformities secondary to vertebral compression fractures (31)(32)(33).…”