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.
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
Vipin Chandran C
BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL
