Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05632835
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.2
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Application of 3D printing guide plate in endoscopic spinal surgery

Condition or Disease	Intervention/Treatment	Phase
Lumbar Disc Herniation; Lumbar Spinal Stenosis; Radicular Pain; Low Back Pain	Other: 3D printing guide plate; Other: Conventional guidance	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery
• Anticipated Study Start Date: Nov 25, 2022
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D printing guide plate group 3D-printed customized guide plate will be used to guide the puncture in endoscopic spinal surgeries.	Other: 3D printing guide plate; 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..
Active Comparator: Conventional guidance group The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.	Other: Conventional guidance; The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.

Outcome Measures

Primary Outcome Measures

1. C-arm fluoroscopy times [Intraoperative]

   Numbers of using C-arm fluoroscopy

Secondary Outcome Measures

1. Puncture time [Intraoperative]

   Time from the first puncture to the last puncture

2. Numerical rating scale [Postoperative 1 day, 2 weeks, 1 month]

   Numerical rating scale (NRS) at 1 day, 2 weeks, 1 month after the operation, with 0-10 numbers and 10 represents most worse condition

3. Patient satisfaction [Postoperative 1 months]

   Patient satisfaction using the modified MacNab criteria (MacNab)

4. Rate of Complications [Intraoperative]

   Rate of Complications like nerve injury, blood, hemotoma, etc.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥18 years old;

2. Pain lasting ≥12 weeks;

3. The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications;

4. Pain intensity≥4 out of 10 on the numerical rating scale (NRS);

5. Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features;

6. Agree with endoscopic spinal surgeries.

Exclusion Criteria:

1. Patient refusal to participate in the study;

2. Pregnant or nursing;

3. Allergies to local anesthetics, contrast dyes or steroids;

4. Significant anatomic deformity (either congenital or acquired) making it difficult to access the target as evidenced by computed tomography/magnetic resonance imaging;

5. Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment;

6. Systemic infection;

7. Injection site infection;

8. Unstable medical or psychiatric condition;

9. Unable to tolerate the surgeries.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pain medicine center of Peking University Third Hospital	Beijing	Beijing	China	100191

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT05632835
• Other Study ID Numbers: TTK04
• First Posted: Dec 1, 2022
• Last Update Posted: Dec 1, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking University Third Hospital: Endoscopic spinal surgeries; 3D printing guide plate
• Additional relevant MeSH terms: Spinal Stenosis; Intervertebral Disc Displacement; Low Back Pain

Study Results

No Results Posted as of Dec 1, 2022