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

NCT06386666 | Not Yet Recruiting

• 1 other identifier: RLRL-CTP
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intervertebral Disc Disorder

Outcome Measures

Primary Outcomes (1)

• Success rate of suture

  After the intraoperative suture was completed, the quality of the suture was evaluated by the investigator. After all subjects completed the operation, the success rate of suture was calculated. Evaluation criteria: 1) No sutures fell off during the suture process; 2) No suture fracture during the suture process; 3) A sterile scale was used to measure annulus fibrosus cleft before and after suture, and medical image data were retained. Finally, the size changes of cleft before and after suture were compared. The size of the wound after suture should be reduced by more than 60% compared with that before suture (the size of the annulus fibrous tear should be determined by its maximum diameter). If all the above three conditions are met, the suture is successful. If any one of the conditions is not met, the suture is failed. Successful rate of suture = Number of successful sutures/total number of sutures \*100%

  Immediately after surgery

Secondary Outcomes (8)

• Annulus fibril cleft decreased in value

  During the surgery.

• Reduced proportion of annular fibril cleft

  During the surgery.

• Intraoperative blood loss

  The day after the surgery

• Suture time

  The day after the surgery

• Treatment success rate

  Six months after surgery

Other Outcomes (1)

• Recurrence rate

  From the day of surgery to 6 months after surgery

Study Arms (1)

The fibrous ring was sutured using a disposable fibrous ring suturing device

EXPERIMENTAL

Device: Disposable fibrous ring sutures

Interventions

Disposable fibrous ring sutures DEVICE

A new disposable fibrous ring suture device developed and produced by 2020 (Beijing) Medical Technology Co., Ltd

The fibrous ring was sutured using a disposable fibrous ring suturing device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, gender unlimited;
• 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;
• The history of lumbar disc herniation is more than 6 weeks, and systematic conservative treatment is ineffective；
• ODI index ≥20 points;
• In the VAS score of bilateral lower limbs, at least one side was ≥4 points;
• 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);
• Voluntarily participate and sign informed consent;
• Be able to communicate well with research doctors, have good compliance, and can follow the requirements of clinical research.

You may not qualify if:

• Active local or systemic infection;
• Patients with lumbar tumors and/or spinal malformations;
• Imaging showed calcification of the posterior longitudinal ligament;
• A history of serious diseases of important organs (such as cardiovascular system, liver, lung, kidney and nervous system);
• There are autoimmune diseases or abnormal coagulation function;
• Previous or planned surgical procedures to fuse or stabilize the lumbar spine during the trial;
• 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;
• Pregnant or lactating women, or those who have a pregnancy plan during the trial period;
• Those who are participating in other clinical trials at the same time;
• Other situations that the researcher considers inappropriate to participate in this study.

Sponsors & Collaborators

• Suzhou Kerui Medical Technology Co., Ltd: lead
• 2020 (Beijing) Medical Technology Co., Ltd: collaborator

MeSH Terms

Conditions

Intervertebral disc disease

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 26, 2024
• Study Start: August 15, 2024
• Primary Completion: August 29, 2025
• Study Completion: November 15, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07