First-time systematic postoperative clinical assessment of a minimally invasive approach for lumbar ventrolateral vertebroplasty in the large animal model sheep

详细信息    查看全文

• 作者：Matthias Bungartz^a ; ^b ; ^{m.bungartz@krankenhaus-eisenberg.de" class="auth_mail" title="E-mail the corresponding author} ; Stefan Maenz^c ; ^d ; Elke Kunisch^b ; Victoria Horbert^b ; Long Xin^b ; Francesca Gunnella^b ; Joerg Mika^b ; ¹ ; ² ; Juliane Borowski^b ; Sabine Bischoff^e ; Harald Schubert^e ; Andre Sachse^a ; Bernhard Illerhaus^f ; Jens Gü ; nster^f ; Jö ; rg Bossert^c ; Klaus D. Jandt^c ; ^d ; ^g ; Raimund W. Kinne^b ; Olaf Brinkmann^a ; ^b
• 关键词：Calcium phosphate cement ; Large animal model ; Minimal-invasive ; Sheep ; Ventrolateral ; Vertebroplasty ; Void defect
• 刊名：The Spine Journal
• 出版年：2016
• 出版时间：October 2016
• 年：2016
• 卷：16
• 期：10
• 页码：1263-1275
• 全文大小：2789 K

文摘

Large animal models are highly recommended for meaningful preclinical studies, including the optimization of cement augmentation for vertebral body defects by vertebroplasty/kyphoplasty.

Purpose

The aim of this study was to perform a systematic characterization of a strictly minimally invasive in vivo large animal model for lumbar ventrolateral vertebroplasty.

Study Design/ Setting

This is a prospective experimental animal study.

Methods

Lumbar defects (diameter 5 mm; depth approximately 14 mm) were created by a ventrolateral percutaneous approach in aged, osteopenic, female sheep (40 Merino sheep; 6–9 years; 68–110 kg). L1 remained untouched, L2 was left with an empty defect, and L3 carried a defect injected with a brushite-forming calcium phosphate cement (CPC). Trauma/functional impairment, surgical techniques (including drill sleeve and working canula with stop), reproducibility, bone defects, cement filling, and functional cement augmentation were documented by intraoperative incision-to-suture time and X-ray, postoperative trauma/impairment scores, and ex vivo osteodensitometry, microcomputed tomography (CT), histology, static/fluorescence histomorphometry, and biomechanical testing.

Results

Minimally invasive vertebroplasty resulted in short operation times (28±2 minutes; mean±standard error of the mean) and X-ray exposure (1.59±0.12 minutes), very limited local trauma (score 0.00±0.00 at 24 hours), short postoperative recovery (2.95±0.29 hours), and rapid decrease of the postoperative impairment score to 0 (3.28±0.36 hours). Reproducible defect creation and cement filling were documented by intraoperative X-ray and ex vivo conventional/micro-CT. Vertebral cement augmentation and osteoconductivity of the CPC was verified by osteodensitometry (CPC>control), micro-CT (CPC>control and empty defect), histology/static histomorphometry (CPC>control and empty defect), fluorescence histomorphometry (CPC>control; all p<.05 for 3 and 9 months), and compressive strength measurements (CPC numerically higher than control; 102% for 3 months and 110% for 9 months).

Conclusions

This first-time systematic clinical assessment of a minimally invasive, ventrolateral, lumbar vertebroplasty model in aged, osteopenic sheep resulted in short operation times, rapid postoperative recovery, and high experimental reproducibility. This model represents an optimal basis for standardized evaluation of future studies on vertebral augmentation with resorbable and osteoconductive CPC.