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临床试验/CTRI/2025/09/094200
CTRI/2025/09/094200尚未招募不适用

A Prospective Comparative Study of Minimally Invasive and Open Transforaminal Lumbar Interbody Fusion Assessing Biochemical Markers Muscle Damage and Clinical Outcomes

Ganesh Kumar1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
ESR, CRP, LDH, CK MB

研究概览

简要总结

Minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is a surgical technique that appears to minimize iatrogenic paraspinal muscle injury thereby enhancing early recovery. In 2010, Villavicencio et al. compared the outcomes of 63 open and 76 MIS TLIF patients, and they reported comparable good clinical outcomes between the two groups, but with a higher neurological complication rate in the MIS group. In a meta-analysis by Wu et al. of 16 open TLIF studies consisting of 716 patients and eight MIS TLIF studies consisting of 312 patients, the authors reported similar fusion and complication rates in both groups. Likewise, multiple studies in the literature support the comparable long-term clinical outcomes between open and MI-TLIF patients.

Muscle injury is one of the points of interest that differentiates these two procedures. Dave et. al. showed that the mean reduction in lean muscle mass of multifidus muscle was greater in open TLIF compared to MIS-TLIF. However, Min et. al. at 1-year follow-up showed that there was less change in fat infiltration percentage and cross-sectional area in the MI-TLIF but there was no significant difference between the two groups. Although percutaneous pedicle screw fixation had positive effects on postoperative trunk muscle performance, clinical outcomes were not significantly different in areas of pain score, JOA score, and patient’s opinion regarding the outcome of the surgery as concluded by Kim and his colleagues. All the above studies evaluated the muscle damage using postoperative MRI imaging at different time intervals. The muscle damage that has been quantified using late postoperative MRI will be biased because of different rehabilitation protocols and variability between individuals, which is unavoidable. However, no study has evaluated or compared the biochemical muscle damage between the open and MI-TLIF groups. We hypothesize that muscle damage in minimally invasive techniques, using retractors through small incisions causes an increase in surrounding muscle pressure in the immediate postoperative period and hence the increased muscle damage compared to the open TLIF procedure.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients who had undergone one level open/minimally invasive transforminal Lumbar fusion surgery.

排除标准

  • More than 2 level surgery, Patient who has undergone interbody fusion for infection, neoplasm, and deformity, Patients who underwent uninstrumented fusion, Age more than 60 years due to osteoporosis Patients operated for tandem canal stenosis, Ongoing psychiatric disease or under psychiatric care Infection during followup Muscular dystrophies, Inflammatory diseases Patients on antioxidants Patients who underwent any kind of physiotherapy or manipulation 1 day prior to the surgery and Neoplasm.

结局指标

主要结局

ESR, CRP, LDH, CK MB

时间窗: 12 hrs before and after surgery

次要结局

  • Preoperative VAS and ODI

研究者

发起方
Ganesh Kumar
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Ganesh Kumar

Department of Spine Services

研究点 (1)

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