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Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery

Primary Purpose

Lumbar Disc Herniation, Lumbar Spinal Stenosis, Radicular Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3D printing guide plate
Conventional guidance
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lumbar Disc Herniation focused on measuring Endoscopic spinal surgeries, 3D printing guide plate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 endoscopic spinal surgeries. 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 target as evidenced by computed tomography/magnetic resonance imaging; Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment; Systemic infection; Injection site infection; Unstable medical or psychiatric condition; Unable to tolerate the surgeries.

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 endoscopic spinal 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
Numerical rating scale (NRS) at 1 day, 2 weeks, 1 month after the operation, with 0-10 numbers and 10 represents most worse condition
Patient satisfaction
Patient satisfaction using the modified MacNab criteria (MacNab)
Rate of Complications
Rate of Complications like nerve injury, blood, hemotoma, etc.

Full Information

First Posted
October 29, 2022
Last Updated
November 20, 2022
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05632835
Brief Title
Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery
Official Title
Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 25, 2022 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (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 endoscopic spinal surgery
Detailed Description
This study applies 3D-printed customized guide plate in assisting the accurate puncture in endoscopic spinal surgeries, in patients with low back pain, lumbosacral radicular pain, abnormal sensation or muscle strength or reflex of lower extremity, cauda equina syndrome, etc. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome. This study involved diseases such as lumbar disc herniation, lumbar spinal stenosis, radiculopathy, disc degeneration, etc. Endoscopic spinal surgeries are effective treatments for these disease. Needle Puncture is the key technology in endoscopic spinal 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 or evoked pain.

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, Radicular Pain, Low Back Pain
Keywords
Endoscopic spinal surgeries, 3D printing guide plate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (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 endoscopic spinal 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 endoscopic spinal surgeries to help to reduce intra-operative radiation, puncture time, etc..
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
Description
Numerical rating scale (NRS) at 1 day, 2 weeks, 1 month after the operation, with 0-10 numbers and 10 represents most worse condition
Time Frame
Postoperative 1 day, 2 weeks, 1 month
Title
Patient satisfaction
Description
Patient satisfaction using the modified MacNab criteria (MacNab)
Time Frame
Postoperative 1 months
Title
Rate of Complications
Description
Rate of Complications 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 endoscopic spinal surgeries. 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 target as evidenced by computed tomography/magnetic resonance imaging; Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment; Systemic infection; Injection site infection; Unstable medical or psychiatric condition; Unable to tolerate the surgeries.
Facility Information:
Facility Name
Pain medicine center of Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery

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