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MagnetOs, Vitoss, and Novabone in a Multi-endpoint Study of Posterolateral Fusion: A True Fusion or Not?
van Dijk, Lukas A; Barrère-de Groot, Florence; Rosenberg, Antoine J W P; Pelletier, Matthew; Christou, Chris; de Bruijn, Joost D; Walsh, William R.
Afiliação
  • van Dijk LA; Kuros Biosciences, Bilthoven.
  • Barrère-de Groot F; Department of Oral and Maxillofacial Surgery, University Medical Center Utrecht, The Netherlands.
  • Rosenberg AJWP; Kuros Biosciences, Bilthoven.
  • Pelletier M; Department of Oral and Maxillofacial Surgery, University Medical Center Utrecht, The Netherlands.
  • Christou C; Surgical and Orthopaedic Research Laboratories, Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia.
  • de Bruijn JD; Surgical and Orthopaedic Research Laboratories, Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia.
  • Walsh WR; Kuros Biosciences, Bilthoven.
Clin Spine Surg ; 33(6): E276-E287, 2020 07.
Article em En | MEDLINE | ID: mdl-31977334
STUDY DESIGN: This study was a multi-endpoint analysis of bone graft substitutes implanted as a standalone graft in a clinically relevant Ovine model of instrumented posterolateral spinal fusion (PLF). OBJECTIVE: The objective of this study was to obtain high-quality evidence on the efficacy of commercial bone graft substitutes compared with autograft in instrumented PLF using a state-of-the-art model with a complete range of assessment techniques. SUMMARY OF BACKGROUND DATA: Preclinical and clinical data on the quality of spinal fusions obtained with bone graft substitutes are often limited. Calcium phosphates with submicron topography have shown promising results in PLF, as these are able to induce bone formation in tissues distant from the host bone, which facilitates bony union. METHODS: Nine female, skeletally mature sheep (4-5 y) underwent posterior pedicle screw/rods instrumented PLF at L2-L3 and L4-L5 using the following bone graft materials as a standalone graft per spinal segment: (1) biphasic calcium phosphate with submicron topography (BCP<µm), (2) 45S5 Bioglass (BG), and (3) collagen-ß-tricalcium phosphate with a 45S5 Bioglass adjunct (TCP/BG). Autograft bone (AB) was used as a positive control treatment. Twelve weeks after implantation, the spinal segments were evaluated by fusion assessment (manual palpation, x-ray, micro-computed tomography, and histology), fusion mass volume quantification (micro-computed tomography), range of motion (ROM) testing, histologic evaluation, and histomorphometry. RESULTS: Fusion assessment revealed equivalence between AB and BCP<µm by all fusion assessment methods, whereas BG and TCP/BG led to significantly inferior results. Fusion mass volume was highest for BCP<µm, followed by AB, BG, and TCP/BG. ROM testing determined equivalence for spinal levels treated with AB and BCP<µm, while BG and TCP/BG exhibited higher ROM. Histologic evaluation revealed substantial bone formation in the intertransverse regions for AB and BCP<µm, whereas BG and TCP/BG grafts contained fibrous tissue and minimal bone formation. Histologic observations were supported by the histomorphometry data. CONCLUSIONS: This study reveals clear differences in efficacy between commercially available bone graft substitutes, emphasizing the importance of clinically relevant animal models with multiendpoint analyses for the evaluation of bone graft materials. The results corroborate the efficacy of calcium phosphate with submicron topography, as this was the only material that showed equivalent performance to autograft in achieving spinal fusion.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Fusão Vertebral / Fosfatos de Cálcio / Transplante Ósseo / Silicatos / Substitutos Ósseos / Vértebras Lombares Tipo de estudo: Guideline Limite: Animals Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Fusão Vertebral / Fosfatos de Cálcio / Transplante Ósseo / Silicatos / Substitutos Ósseos / Vértebras Lombares Tipo de estudo: Guideline Limite: Animals Idioma: En Ano de publicação: 2020 Tipo de documento: Article