ORTHOSPINE FITNESS: Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- radiological images
研究概览
简要总结
The present study is related to the project "ORTHOSPINE FITNESS: WHICH MARKERS OF MUSCULOSKELETAL HEALTH CAN EXPLAIN COMPLICATIONS IN SPINE SURGERY?", winner of the Ministry of Health Call, financed by the European Union, "M6/C2_CALL 2023", Project Code " PNRR- MCNT2-2023-12378098", Call section "Non-chronic chronic diseases transmissible diseases (MCnT2) with a high impact on health systems".
Complications of spinal surgery still represent a significant and unsolved problem. Their incidence is between 7 and 20%, with a high percentage of mechanical complications observed in patients operated on for degenerative pathologies. Readmissions, re-operations and subsequent rehabilitation treatments have a heavy impact on patients and the entire healthcare system.
详细描述
The study proposed, financed through the "PNRR-MCNT2-2023-12378098" call, is a multicenter study on a large cohort of patients undergoing spinal surgery for degenerative pathologies of the thoraco-lumbar spine, which has as its general objective to establish a comprehensive preoperative screening of bone health and the musculoskeletal system, combining advanced imaging and modeling (HRpQCT images of bone microstructure at peripheral sites and related computational assessment of bone mechanical properties), assessment of physical fragility (including muscle strength and assessment of proprioception/fall risk), cellular and molecular analyzes of bone fitness and bone-muscle cross-talk, and assessment of nutritional status.
The results of the project will allow us to: (i) define a concept of "surgical suitability" to evaluate patients candidates for elective spinal surgery and possibly improve the surgical decision-making process (for example the choice of fixation and instrumentation); (ii) identify a minimum set of significant and independent markers to monitor in future interventional studies aimed at reducing the risk of adverse events in spinal surgery, (iii) allow patient-specific preoperative interventions (such as nutritional supplementation, physical pre-habilitation or administration of bone anabolic agents)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years;
- •diagnosis of degenerative pathology of the spinal column of the thoraco-lumbo-sacral tract;
- •patients candidates for surgical treatment for the aforementioned pathology during the study period;
- •willingness to participate in the study and sign the specific informed consent
排除标准
- •presence of tumors or infections in the spinal column;
- •presence of degenerative pathology of the spine without surgical indication;
- •presence of degenerative pathology of the spinal column at the cervical level.
结局指标
主要结局
radiological images
时间窗: at baseline (day 0)
constructed mechanical models from HR-pQCT data to quantify mechanical stiffness and bone strength at peripheral sites, which have already been shown to be effective predictors of fractures independent of DXA, and attempted their association with adverse events monitored during the follow-up
biological samples
时间窗: at baseline (day 0), after 6 months, after 12 months
The biopsies will be analyzed for analyzes at the level of secreted proteins (secretome) and gene expression. The bone harvest will be waste material obtained from the laminectomy, while the muscle harvest will be carried out in very small quantities from the posterior paravertebral muscles
pain
时间窗: at baseline (day 0), after 12 months
Pre-operative baseline assessment of pain level will be performed by self-administering validated questionnaires with the visual analogue scale (0-10)
Quality of life
时间窗: at baseline (day 0), after 6 months, after 12 months
the quality of life of the patients will be tracked by questionnairs
nutritional informations
时间窗: since day 1 to day 14
administration of a questionnaire to patients food frequency (Food Frequency Questionnaire - FFQ), which is an accurate measurement of nutrient intake within a 14-day period, using a diary food.
次要结局
未报告次要终点