跳至主要内容
临床试验/CTRI/2025/03/083692
CTRI/2025/03/083692尚未招募2/3 期

Randomised control trial on precision and performance of 3D-printed patient-specific surgical guides (PSSG) in resource-constrained environments in comparison to conventional free-hand surgical methods.

Believers Church Medical college Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年4月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
1)Accuracy of the surgical procedure

研究概览

简要总结

In spinal fusion, pedicle screws are utilized to stabilize the spine using a posterior approach. Traditional surgical techniques, like the insertion of a free-hand screw, mostly depend on the experience of the surgeon and anatomical landmarks.Pedicle screw insertion guided by images (Image guided surgery) can increase placement precision, but it is expensive.Research on patient-specific surgical guides (PSSG) made using that particular  patient’s scan data has demonstrated the need for reduced intra operative X-rays with comparable accuracy rates. 3D printed  PSSG also  reduces the  learning curve for the operating surgeon compared to conventional free hand technique. Our study is aimed at bringing out the advantages of 3D printed PSSG’s over traditional free hand technique especially in a resource constrained environment.Patients undergoing thoracic and lumbar pedicle screw fixation for traumatic and degenerative spinal disease , who satisfy the inclusion and exclusion criteria will be enrolled into 2 arms after randomization. Data will be collected after blinding and analyzed .

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing thoracic and lumbar pedicle screw fixation for traumatic and degenerative spinal disease.
  • Age more Than 18 years.
  • Informed consent obtained.

排除标准

  • Previous spinal surgery in the same level Severe comorbidities that could affect healing or outcomes Congenital deformities of spine Pregnancy.

结局指标

主要结局

1)Accuracy of the surgical procedure

时间窗: At admission preop , post op at 1 week, at 3 months

2)Measurement: Post-operative imaging (e.g., CT or X-ray) to assess medial, lateral, superior or inferior breach.

时间窗: At admission preop , post op at 1 week, at 3 months

Secondary Outcomes:

时间窗: At admission preop , post op at 1 week, at 3 months

Operative time (measured in minutes)

时间窗: At admission preop , post op at 1 week, at 3 months

Blood Loss

时间窗: At admission preop , post op at 1 week, at 3 months

radiation exposure (number of shoots required)

时间窗: At admission preop , post op at 1 week, at 3 months

Cost in Indian rupees

时间窗: At admission preop , post op at 1 week, at 3 months

次要结局

  • 1)Accuracy of the surgical procedure(2)Measurement: Post-operative imaging (e.g., CT or X-ray) to assess medial, lateral, superior or inferior breach.)

研究者

发起方
Believers Church Medical college Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Vipin Chandran C

BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL

研究点 (1)

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