Clinical Evaluation of TruFUSE® Lumbar Facet Fusion System

Abstract

Introduction: The TruFUSE ® lumbar facet fusion system is a unique allograft milled bone dowel used to fuse facet joints. We evaluated subjects undergoing TruFUSE ® fusion for stable grade I spondylolisthesis and stenosis comparing operative time, length of stay, blood loss and outcome to a similar literature-based cohort of patients undergoing pedicle screw fusion (PSF). Methods: From 2009 to 2011, 41 subjects (17 M, 24 F, aver. age 69.5 yr) underwent TruFUSE ® facet fusion along with transverse process bone fusion and laminectomy. Length of stay, operative time, blood loss and outcomes were compared to eight literature-based cohort that analyzed similar parameters following pedicle screw fusion. Results: The 41 subjects' mean operative time for laminectomy, transverse process fusion and TruFUSE ® facet fusion was 106 min, with a mean blood loss of 145 cm 3 , and a mean hospital stay of 1.7 days (77% one day). A follow-up at average six months, 33 (80%) subjects reported subjective outcomes of "excellent" or "somewhat improved", four (10%) "unchanged" and four (10%) "worse". Flexion and extension radiographs showed 39 of the 41 patients (95%) had spinal stability at an average six months post-op and all (100%) had signs of early fusion. Discussion: TruFUSE ® subjects had significantly (p < 0.0001) shorter surgeries (106 min compared to the literature data range of 185-240 min); significantly (p < 0.0001) shorter hospitalization (1.7 days compared to 4-19 days range). Mean estimated blood loss (EBL) was significantly lower (p < 0.001) (145 cm 3 compared to 321 cm 3 and 1082 cm 3 range for PSF). Subjective outcome and radiographic stability were comparable between groups. Conclusion: This comparison using the TruFUSE ® lumbar facet fusion system demonstrates improvements in length of stay, surgical blood loss, and operative time in our selected patient population compared to several published lumbar pedicle screw fusion systems outcomes. There may be potential economic benefits as a result of these improvements.

Initial Experience With a Full Endoscopic Facet Fusion in Combination With Endoscopic Interbody Fusion

“…Targeting the facets as the only fusion site has been proposed using a dedicated interfacetary grafting material. Marron et al demonstrated the successful implementation of an allograft milled bone dowel facet fusion system to augment laminectomy and transverse process fusion procedures for the treatment of stable Grade I degenerative spondylolisthesis in a cohort of 41 patients [12]. They demonstrated that 95% of the patients had spinal stability at an average of six months post-operatively and 100% had signs of early fusion [12].…”

Lateral trochlear lengthening osteotomy

“…The subjective evaluation was conducted through the Kujala Anterior Knee Pain Scale [ 21 ], the Lysholm Knee Score and the Tegner Activity Score [ 22 ]. Furthermore, patients were asked to subjectively evaluate the outcome of the operation according to the following options (subjective evaluation score): 5—excellent; 4—somewhat improved; 3—unchanged; 2—somewhat worse; 1—significantly worse [ 23 ], and asked if they would have the operation again. Lastly, isokinetic knee flexor and extensor strength tests were performed at 60°/s using an isokinetic dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA).…”

Percutaneous facet joints arthrodesis technology in surgical treatment of degenerative diseases of lumbar spine

“…Благодаря меньшей травматичности хирургического вмешательства, низкой интраоперационной кровопотере, а также сокращению длительности реабилитации пациентов эти технологии выглядят В настоящее время опубликованы результаты исследований, в которых изучались альтернативные варианты фиксации ПДС с применением имплантатов, не только стабилизирующих сегмент, но и создающих условия для формирования заднего костного блока. Наиболее близкие к разработанной нами технологии методы межсуставной фиксации рассматриваются либо как вариант лечения изолированного поражения дугоотростчатых суставов, либо в комбинации с межтеловым спондилодезом, однако перкутанная транспедикулярная фиксация в них не включена [17,21,22]. Кроме того, данные технологии подразумевают применение открытого или полуоткрытого доступа к дугоотростчатому суставу для установки имплантата.…”