RESUMO
STUDY DESIGN: Prospective observational study. OBJECTIVE: The population of patients with advanced stages of cancer, including metastatic spinal disease, is growing because of better treatment options allowing for longer control of disease. The main goal of treatment for these patients is to improve or maintain their health-related quality of life (HRQOL). A spine oncology-specific outcome measure has been developed by the Spine Oncology Study Group and validated through international studies. We proposed to translate and validate the questionnaire in Italian language. METHODS: The cross-cultural adaptation of the questionnaire has been performed according to guidelines previously proposed. After this process, an observational prospective study has been conducted to validate the efficacy of SOSGOQ in Italian language. SOSGOQ has been compared to SF-36 (Short Form Health Survey-36), a generic validated questionnaire to assess HRQOL. Starting from January 2020, SOSGOQ and SF-36 questionnaires were auto-administered to 150 patients affected by spinal metastases who provided written informed consent for study participation. RESULTS: The confirmatory factor analysis on the 4 domains examined showed a good model fit (comparative fit index, .95; RMSEA .07 (90% CI, .05-.09) and SRMR, .05), endorsing construct validity. The analysis of concurrent validity demonstrated strong correlation for physical function, pain and mental health domains with the corresponding domain scores of SF-36. The reliability across item was high with a Cronbach's alpha coefficient of .91. CONCLUSIONS: The statistical analysis of the results will allow to accept the Italian version of SOSGOQ as a specific and efficient tool to measure HRQOL in Italian-speaking patients affected by spinal metastases.
RESUMO
BACKGROUND: Protocols including combination of surgery and radiotherapy are more and more frequent in the treatment of bone tumors of the spine. In metastatic disease, combination of surgery and radiotherapy is since long time accepted, as based on clinical evidence. In primary tumors, combination of surgery and radiotherapy can be considered in all the cases in which a satisfactory oncological margin cannot be achieved: high-grade malignancies, recurrent tumors, huge tumors expanding in an extracompartimental area, and when tumor-free margin requires unacceptable functional sacrifices. However, metal implants are an obstacle in the collaboration between surgeons and radiation oncologists. Carbon-fiber-reinforced polyethil-ether-ether-ketone (CFR-PEEK) composite implants could make easier and more effective the treatment as radiolucent and not interfering with ionizing radiation and accelerated particles. The purpose of this article is to report the preliminary results from a cohort of patients treated with CFR-PEEK and to evaluate the safety and the non-inferiority of the device respect the commonly used titanium implants. MATERIALS AND METHODS: This study concerns an ambispective cohort series of 34 tumor patients (14 metastases and 20 primaries, most of them recurrent) submitted to thoracic and lumbar spine fixation with a CFR-PEEK composite implants. Oncologic surgery was palliative decompression and fixation in 9 cases, tumor excision in 21, and enbloc resection in 4. Data collected for this preliminary report were all intraoperative remarks, incidence of complications, changes in neurological status, local control, and survival. All the cases were followed 6-36 months (mean 13 months). RESULTS: Only one intraoperative screw breakage occurred out of 232 implanted screws. Pain control and neurological improvement were the early clinical results. Two sacral screws loosening were found at 9 and 12 months in multilevel constructs performed on multirecurrent tumors. Six local recurrences were early found thanks to the implant radiolucency. Radiation oncologists' opinion was favourable as concerning better treatment planning on CT and lacking of scattering effect during the treatment. CONCLUSIONS: No artifacts on imaging studies mean early local recurrence detection. For radiation oncologists, no artifacts on imaging studies mean easier planning and no scattering effect means more effective and safe radiotherapy, particularly when particles are used. Moreover, it seems that the clinical use of CFR-PEEK composite implants may be safe and at least comparable with the commonly used titanium implants in terms of intraoperative complications, stability at weight bearing and at functional recovery. Larger patient series and longer follow-up are required to confirm these data.
