Clinical trial NCT06386666: A Clinical Trial to Evaluate the Safety and Efficacy of Single-use Fibrous Ring Sutures for the Suture of Fibrous Ring Incision After Nucleus Pulposus Removal
Official title: A Prospective, Multicenter, Single-group, Target-value Clinical Trial to Evaluate the Safety and Efficacy of Single-use Annular Sutures for Annular Incisions Following Nucleus Pulposus Removal
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intervertebral Disc Disorder
Lead sponsor: Suzhou Kerui Medical Technology Co., Ltd
Sponsor class: OTHER
Collaborators: name: 2020 (Beijing) Medical Technology Co., Ltd
First posted: 2024-04-26
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. The success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, VAS pain score (low back, bilateral lower extremities), Oswestry index (ODI index), and Short were evaluated The effectiveness evaluation results of Form-12 health survey (SF-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, gender unlimited;
2. Meet the diagnosis of lumbar disc herniation (refer to the Guidelines for Diagnosis and Treatment of Lumbar disc herniation), and expect to undergo single-level disc nucleus pulposus extraction;
3. The history of lumbar disc herniation is more than 6 weeks, and systematic conservative treatment is ineffective；
4. ODI index ≥20 points;
5. In the VAS score of bilateral lower limbs, at least one side was ≥4 points;
6. The score of the three evaluation indicators according to the modified Pfirrmann grade, age and disc height is no more than 7 points (see Annex 1 for the criteria);
7. Voluntarily participate and sign informed consent;
8. Be able to communicate well with research doctors, have good compliance, and can follow the requirements of clinical research.

Exclusion Criteria:

1. Laboratory examination (blood routine examination, blood biochemistry, coagulation function and blood pregnancy, etc.), imaging examination (MRI) and vital signs examination have abnormal results with clinical significance, and the researchers believe that they are not suitable for inclusion;
2. Active local or systemic infection;
3. Patients with lumbar tumors and/or spinal malformations;
4. Imaging showed calcification of the posterior longitudinal ligament;
5. A history of serious diseases of important organs (such as cardiovascular system, liver, lung, kidney and nervous system);
6. There are autoimmune diseases or abnormal coagulation function;
7. Previous or planned surgical procedures to fuse or stabilize the lumbar spine during the trial;
8. Intraoperative exploration of the location of the annulus fibriatus could not satisfy the requirement that the needle entry point was more than 2mm away from the margin of the annulus fibriatus;
9. Pregnant or lactating women, or those who have a pregnancy plan during the trial period;
10. Those who are participating in other clinical trials at the same time;
11. Other situations that the researcher considers inappropriate to participate in this study.

Primary outcomes:
measure: Success rate of suture
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Annulus fibril cleft decreased in value
timeFrame: During the surgery.
measure: Reduced proportion of annular fibril cleft
timeFrame: During the surgery.
measure: Intraoperative blood loss
timeFrame: The day after the surgery
measure: Suture time
timeFrame: The day after the surgery
measure: Treatment success rate
timeFrame: Six months after surgery
measure: VAS pain score (lower back, bilateral lower limbs)
timeFrame: Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery
measure: SF-12 rating
timeFrame: Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery
measure: ODI index
timeFrame: Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery
Other outcomes:
measure: Recurrence rate
timeFrame: From the day of surgery to 6 months after surgery
Locations:
Study officials:
References: