Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries
Primary Purpose
Lumbar Disc Herniation, Lumbar Spinal Stenosis, Radiculopathy
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3D printing guide plate
Conventional guidance
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years old,
- Pain lasting ≥12 weeks,
- The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
- Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
- Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features,
- Agree with spinal minimally invasive and interventional surgery treatments, including endoscopic spinal surgery, radiofrequency treatment of the medial branch of the dorsal ramus or nerve root or sensory ganglion or joint, disc coblation nucleoplasty, etc.
Exclusion Criteria:
- Patient refusal to participate in the study,
- Pregnant or nursing
- Allergies to local anesthetics, contrast dyes or steroids
- Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
- Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
- Steroid injection within the previous 12 weeks,
- Systemic infection,
- Injection site infection,
- Unstable medical or psychiatric condition
Sites / Locations
- Pain medicine center of Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3D printing guide plate group
Conventional guidance group
Arm Description
3D-printed customized guide plate will be used to guide the puncture in the spinal minimally invasive and interventional surgeries.
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.
Outcomes
Primary Outcome Measures
C-arm fluoroscopy times
Numbers of using C-arm fluoroscopy
Secondary Outcome Measures
Puncture time
Time from the first puncture to the last puncture
Numerical rating scale (NRS)
NRS at 1 day, 2 weeks, 1 month after the operation
MacNab
Patient satisfaction using the modified MacNab criteria
Complications
Complication like nerve injury, blood, hemotoma, etc.
Full Information
NCT ID
NCT05487690
First Posted
August 2, 2022
Last Updated
October 29, 2022
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05487690
Brief Title
Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries
Official Title
Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Application of 3D printing guide plate in spinal minimally invasive and interventional surgeries
Detailed Description
This study applies 3D-printed customized guide plate in assisting the accurate puncture in endoscopic spinal surgery, radiofrequency ablation of the medial branch of the dorsal ramus or sensory ganglion or joint, disc coblation nucleoplasty, etc. in patients with low back pain, lumbosacral radicular pain, joint pain, perineal pain and pelvic pain. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.
This study involved lumbar disc herniation (LDH), lumbar spinal stenosis (LCS), radiculopathy, facet joint disorder syndrome, ischemic pain of the lower extremity, cancer pain, etc.. Spinal minimally invasive and interventional surgeries are effective treatments for these disease. Needle Puncture is the key technology in spinal minimally invasive and interventional surgeries.
In the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. If the position of the needles is not satisfactory, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem could be well solved by applying the 3D printing guide plate.
The key processes for the 3D printing guide plate procedure: the model of the spine or bone is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. The final position of needle is confirmed by C-arm fluoroscopy or CT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Lumbar Spinal Stenosis, Radiculopathy, Lumbosacral Facet Joint Syndrome, Ischemic Pain of the Lower Extremity, Spinal Minimally Invasive and Interventional Surgeries, 3D Printing Guide Plate, Radicular Pain, Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D printing guide plate group
Arm Type
Experimental
Arm Description
3D-printed customized guide plate will be used to guide the puncture in the spinal minimally invasive and interventional surgeries.
Arm Title
Conventional guidance group
Arm Type
Active Comparator
Arm Description
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.
Intervention Type
Other
Intervention Name(s)
3D printing guide plate
Intervention Description
3D-printed customized guide plate will be used to guide the puncture in the spinal minimally invasive and interventional surgeries. to help to reduce intra-operative radiation.
Intervention Type
Other
Intervention Name(s)
Conventional guidance
Intervention Description
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.
Primary Outcome Measure Information:
Title
C-arm fluoroscopy times
Description
Numbers of using C-arm fluoroscopy
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Puncture time
Description
Time from the first puncture to the last puncture
Time Frame
Intraoperative
Title
Numerical rating scale (NRS)
Description
NRS at 1 day, 2 weeks, 1 month after the operation
Time Frame
Postoperative 1 day, 2 weeks, 1 month
Title
MacNab
Description
Patient satisfaction using the modified MacNab criteria
Time Frame
Postoperative 1 months
Title
Complications
Description
Complication like nerve injury, blood, hemotoma, etc.
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years old,
Pain lasting ≥12 weeks,
The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features,
Agree with spinal minimally invasive and interventional surgery treatments, including endoscopic spinal surgery, radiofrequency treatment of the medial branch of the dorsal ramus or nerve root or sensory ganglion or joint, disc coblation nucleoplasty, etc.
Exclusion Criteria:
Patient refusal to participate in the study,
Pregnant or nursing
Allergies to local anesthetics, contrast dyes or steroids
Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
Steroid injection within the previous 12 weeks,
Systemic infection,
Injection site infection,
Unstable medical or psychiatric condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuiqing Li
Phone
+86 01082265690
Email
bjfdfx@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qipeng Luo
Phone
+86 01082265026
Email
1293194276@qq.com
Facility Information:
Facility Name
Pain medicine center of Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuiqing Li, MD
Phone
01082266699
Email
bjfdfx@126.com
First Name & Middle Initial & Last Name & Degree
Qipeng Luo, MD
Phone
01082265026
Email
1293194276@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries
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