Anterior cervical fusion with a bio-resorbable composite cage (beta TCP–PLLA): clinical and radiological results from a prospective study on 20 patients

Abstract

A resorbable composite material (40% PLLA and 60% beta TCP) with a high breaking strength and capacity to withstand plastic and elastic strain has been developed for cervical interbody fusion. This is a prospective study to evaluate clinical and radiological results of 20 patients implanted with 27 cages (mean follow-up, 27 months). Clinical (neck disability index, VAS, neurological evaluation) and radiological (anteroposterior, lateral, bending X-rays) data were assessed before and after surgery. At the end of the study, CT scan was performed to evaluate fusion, resorption of the cage and density of the new tissue substituting the cage. The mean patient age was 50.3 years (range, 18-79 years). The average improvement was 55% for neck pain, 83% for arm pain and 65% for NDI, with 85% good or excellent results at final outcomes. Radiologically, lordosis was significantly improved (mean gain of 5.4°and 3.7°for overall and segmental lordosis, respectively). This correction was conserved in 95% of cases. Fusion was obtained in 96% (CT evaluation). Resorption was started in all cases and completed in an average of 36 months after surgery. The mean density of tissue substituting the cage was 659 UH with a range, of 455-911 UH (compatible with bone nature). Over time, the amount of bony tissue increased and the graft remodelled with an increase in density value. This demonstrates a biological activity and changing bone mineral content of this tissue. The new composite cage under investigation provides long-term fusion without loss of correction or inflammatory reaction. The ceramic block guarantees the maintenance of the disc height and its slow resorption allows long-term fusion and stability with good and reliable clinical and radiological outcomes.

Anterior Cervical Interbody Fusion Using Polyetheretherketone Cage Filled With Autologous and Synthetic Bone Graft Substrates for Cervical Spondylosis: Comparative Analysis Between PolyBone^® and Iliac Bone

“…Hydroxyapatite and calcium phosphate have good biocompatibility and osteoconductive capacity, 13,22) and a mixture of calcium phosphate and hydroxyapatite has shown good clinical and radiological outcomes as an iliac bone graft alternative. 6,7,9,[14][15][16][17]21,24) PolyBone } (Kyungwon Medical Co., Ltd., Seoul, Korea) is a beta-tricalcium phosphate material designed to act as a substitute bone graft. To assess the efficacy of PolyBone for cervical interbody fusion, we retrospectively examined clinical and radiological outcomes in patients who underwent ACDF using PolyBone, and compared these with outcomes achieved in patients who underwent ACDF using iliac grafts.…”

The Performance Envelope of Spinal Implants Utilizing Thermoplastic Materials

“…The authors reported positive clinical and radiologic results in terms of improved pain scores and CT-based fusion evaluation at a mean followup of 27 months. No incidences of cage migration or material complications were reported, and an average resorption of 64% was reported at latest follow-up (Debusscher et al 2009). …”

Interação biológica de membranas poliméricas bioativas em falhas ósseas induzidas em tíbias de coelhos

“…Estas características são muito importantes em aplicações clínicas em função de serem desnecessárias novas intervenções cirúrgicas para a retirada do material implantado (WARRER et al, 1992;WILSON, 1993;WEILER et al, 2000;BARBANTI;ZAVAGLIA, 2005;DEBUSSCHER et al, 2009 GROOT, 1979;PAUL et al, 1992;SCHINDELER et al, 2008). Em estudo mecânico com fraturas de fêmures em ratos, observou-se que o calo ósseo desorganizado e mais volumoso foi superior ao calo remodelado em ensaios de flexão de três pontos (LI et al, 1999).…”

“…Os biomateriais poliméricos usados no experimento, por possuírem propriedades bioativas incluindo osteoindução, osteocondução e sinalização celular (MENEZES;FREITAS;GONÇALVES, 2009;OLIVEIRA, 2010;ROCHA, 2010;DINARVAND et al, 2011) ZHANG et al, 2004;ROSANNA;VITTORIO;SANTI, 2004;SANG-HOON, 2004;DECLERCQ et al, 2005;DEBUSSCHER et al, 2009).…”

“…A exemplo deste experimento, várias pesquisas foram realizadas no intuito de desenvolver e avaliar materiais com propriedades osteoindutoras / osteocondutoras (OHARA et al, 1995;SERVICE, 2000;ROETHER et al, 2002;SAKATA;RINCON;DUEK, 2004;TEMENOFF et al, 2004;2005;FEINBERG;AGHALOO;CUNNINGHAM JR., 2005;ZHANG et al, 2005;SANGINÁRIO et al, 2006;MENEZES;FREITAS;GONÇALVES, 2009) e biomateriais semelhantes para as situações supracitadas ou indivíduos hiporreativos são motivo de avaliações clínicas e vários trabalhos demonstraram bons resultados (BOYNE, 1969;CASTNER;RATNER, 2002;KRUYT et al, 2006;DEBUSSCHER et al, 2009 …”