Clinical and radiological evaluation of Trabecular Metal and the Smith–Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up

A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal™ (TM) to the traditional Smith–Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A–P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2 years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24 months postoperatively. Follow-ups at 12 and 24 months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (P < 0.05). The accuracy of the measurements was calculated to be 2.4°. Operating time was shorter for fusion with TM compared with autograft; mean times were 100 min (SD 18) and 123 min (SD 23), respectively (P = 0.001). The patients’ global assessments of their neck and arm symptoms 2 years postoperatively for the TM group were rated as 79% much better or better after fusion with TM and 75% using autograft. Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group. There was no statistically significant difference in clinical outcomes between fusion techniques or between patients who appeared radiologically fused or non-fused. There was no difference in pelvic/hip pain between patients operated on with or without autograft. In our study, Trabecular Metal showed a lower fusion rate than the Smith–Robinson technique with autograft after single-level anterior cervical fusion without plating. There was no difference in clinical outcomes between the groups. The operative time was shorter with Trabecular Metal implants

Aspectos da distribuição de tecidos músculo-esqueléticos de um banco de tecidos Aspects of the distribution of musculoskeletal tissues by a tissue bank

OBJETIVO: Avaliar as características da distribuição desses por um Banco de Tecidos no Brasil. MÉTODOS: Base de dados do Banco de Tecidos entre setembro de 2006 e junho de 2008. Características dos receptores foram tabuladas. Os tipos de tecidos processados foram: cabeças femorais, osso metafisio-epifisário, osso cortical, ossos curtos ou chatos e tendões. O destino dos enxertos foi analisado. Frequências das distribuições foram obtidas e analisadas. RESULTADOS: Foram distribuídas 734 unidades tecidos fresco-congelados, transplantadas em 683 receptores. Doadores de múltiplos órgãos originaram 97,9% dos tecidos e doadores vivos os demais. Foram transplantados 489 unidades de osso córtico-esponjoso, 137 de osso metafisio-epifisário, 44 de osso chato ou curto, 3 de tendão, 29 de osso particulado e 32 de cabeças femorais. A média de idade dos receptores foi 50,3 anos, sendo 59,5% do sexo feminino e 40,5% do masculino. Os tecidos foram destinados para uso ortopédico em 21,1% dos casos e buco-maxilo-facial, em 78,9%. CONCLUSÃO: O Banco de Tecidos aumentou o número de distribuições em resposta à demanda crescente de tecidos, principalmente para uso em cirurgia buco-maxilo-facial.<br>OBJECTIVE: Is to evaluate the characteristics of the distribution of these grafts by a Tissue Bank in Brazil. METHODS: Tissue Bank database from September 2006 to June 2008. The characteristics of the recipients were drawn up in the table form. The types of tissue processed were: femoral heads, metaphyseal-epiphyseal bone, cortical bone, flat or short bones and tendons. The intended purpose of the grafts was analyzed, and distribution frequencies were also obtained and analyzed. RESULTS: Altogether, 734 units of fresh-frozen tissue were distributed and transplanted into 683 recipients. In terms of origin of the tissues, 97.9% came from multiple organ donors, and the remainder from living donors. A total of 489 units of cortical bone were transplanted, 137 of metaphyseal-epiphyseal bone, 44 of short or flat bones, 3 of tendon, 29 of particulate bone and 32 femoral heads. The mean age of the recipients was 50.3 years; 59.5% were women and 40.5% men. The tissues were used in orthopedic surgeries in 21.1% of the cases, and in oral and maxillofacial procedures in 78.9%. CONCLUSION: The Tissue Bank has increased the number of distributions in response to the growing demand for tissues, particularly for use in oral and maxillofacial procedures