Robot-Assisted US-Based Vertebral Segmentation for Pedicle Screw Trajectory Identification: A Comparison With Handheld US-Reconstructions and Ground Truth CT-Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Pedicle screw placement - Trajectory errors in terms of direction
研究概览
简要总结
This other clinical trial compares robot-assisted US scanning with handheld US scanning and ground-truth CT data of the lumbar spine in healthy, young volunteers. The main questions it aims to answer are:
- Is a 3D reconstruction of a lumbar spine from robot-assisted US scanning equivalent to or better quality than a 3D reconstruction from handheld US scanning?
- Can a machine learning algorithm automatically segment the bone anatomy from robot-assisted and handheld US scanning to generate 3D lumbar spine reconstructions?
- Can pedicle screw trajectories be identified based on posterior vertebral landmarks of 3D reconstructions of lumbar spines from both robot-assisted and handheld US scanning?
Participants will:
- fill out a medical history questionnaire
- get clinically examined
- have an ultra-low-dose (ULD) CT Scan of the vertebra L1 to S1
- have a handheld US scan of the vertebra L1 to S1
- have a robot-assisted US Scan of the vertebra L1 to S1
- fill out a post-study questionnaire
详细描述
The following hypotheses are tested:
- A 3D reconstruction of a lumbar spine from robot-assisted US scanning is equivalent to or of better quality than a 3D reconstruction handheld US scanning.
- A machine learning algorithm can automatically segment the bone anatomy from robot-assisted and handheld US scanning to generate said 3D lumbar spine reconstructions.
- Pedicle screw trajectories can be identified based on posterior vertebral landmarks of 3D reconstructions of lumbar spines from robot-assisted and handheld US scanning.
The project consists of three pillars as objectives to help solidify the US reconstruction of the lumbar spine as a novel navigational method in interventional spine applications.
- 1st Pillar: A first-of-a-kind in-vivo robot-assisted and handheld US reconstruction dataset of the lumbar spine in healthy subjects is acquired. The collected dataset is compared to ground truth CT data to assess quality.
- 2nd Pillar: A novel machine learning algorithm is trained to segment the US reconstructions of all the collected lumbar spine data into each identified vertebra.
- 3rd Pillar: A novel measurement method to identify pedicle screw trajectories based on posterior vertebral landmarks is applied to the segmented US reconstructions. This research further promotes US for future use in robot-assisted interventions.
This project consists of two phases. First, a preliminary pilot study is planned to assess the project's feasibility and improve the planned workflow and safety measures. For this pilot, the investigators will mouth-to-mouth recruit two volunteers. After completing and thoroughly evaluating the pilot, the investigators will conduct the actual study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Oral and written informed consent from the volunteer
- •Volunteers aged ≥18 y/o and ≤35 y/o
- •BMI above or equal to 19 kg/m2 or below or equal to 25 kg/m2
- •Proficient in German or English language
排除标准
- •Documented volunteer refusal
- •Volunteers in whom CT cannot be performed
- •Positive pregnancy test prior to radiology (contraindication to CT)
- •Pregnancy
- •Chronic pain in the lumbar spine
- •Moderate or severe deformity of the lumbar spine
- •Any prior intervention to the lumbar spine:
- •Chiropractic adjustment therapy
- •Injections such as local anesthetics and corticosteroids
- •Fracture of the lumbar spine
- •BMI below 19 kg/m2 or above 25 kg/m2
- •Anatomies, such as subcutaneous fat or tendon, occlude the bony surface or do not allow a clear image in the US scan
结局指标
主要结局
Pedicle screw placement - Trajectory errors in terms of direction
时间窗: Up to 1 year
Evaluating the directional accuracy of the Pedicle screw placement
Pedicle screw placement - Trajectory errors in terms of position
时间窗: Up to 1 year
Evaluating the positional accuracy of the Pedicle screw placement
Target registration errors between US reconstructions and ground truth CT data
时间窗: Up to 1 year
Evaluating the accuracy of the US reconstructions
次要结局
- Gender(Up to 4 weeks)
- Tegner activity score(Up to 4 weeks)
- ODI Oswestry Low Back Pain Disability Index(Up to 4 weeks)
- Age(Up to 4 weeks)
- Smoking status(Up to 4 weeks)
- BMI(Up to 4 weeks)
研究者
Philipp Fürnstahl
Prof. Dr. Sc., Assistant Professor in Orthopedic Computer Science
Balgrist University Hospital