The Effect of Protein Supplement on Vertebral Fusion and Enhanced Recovery After Posterior Spine Fusion Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Rate of vertebral fusion in CT scan
研究概览
简要总结
Receiving protein can affect the bone formation and maintenance by providing a structural matrix of the bone, optimizing the level of IGF-1, increasing intestinal calcium absorption, transferring phosphorous, and improving muscle strength.Therefore, protein may be effective on vertebral fusion by such mechanisms. In this trial patients undergoing elective posterior spine fusion surgery are divided into two groups of intervention or control.
详细描述
A randomized, double blind, controlled trial will be conducted in patients undergoing elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 80 eligible posterior spine fusion surgery patients, aged ≥ 18 years. Intervention patients will be received 36 grams of protein supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and control patients will be received Carbo Mass along with diet containing 1.2 g/kg/day of protein 30 days after surgery. Patients will be evaluated for occurrence of vertebral fusion and enhanced recovery after 3 months surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Allergy or intolerance to protein or maltodextrine supplement
- •Unwillingness to continue cooperation
研究组 & 干预措施
protein supplement
Intervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery.
干预措施: protein supplement (Drug)
Carbo Mass
Control patients will be received protein diet (1.2 g/kg/day) and Carbo Mass for 1 month after surgery.
干预措施: Carbo Mass (Other)
结局指标
主要结局
Rate of vertebral fusion in CT scan
时间窗: 6 months after surgery
Rate of formation of a solid bony Union in CT scan
次要结局
- Rate of of wound infection(15 days, 1 and 3 month after surgery)
- Rate of wound healing(Discharge, 15 days and 1 month after surgery)
- score of pre and postoperative pain(baseline, discharge, 15 days 1 and 3 month after surgery)
- Concentration of serum IGF-1(baseline, 1 month after surgery)
- Concentration of serum albumin(baseline, 1 month after surgery)
- Concentration of serum total protein(baseline, 1 month after surgery)
- Concentration of serum hsCRP(baseline, 48 hour,15 days and 1 month after the surgery)
研究者
Zahra Vahdat Shariatpanahi
Principal Investigator
Shahid Beheshti University