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

Launched by SUZHOU KERUI MEDICAL TECHNOLOGY CO., LTD · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of suture, called a single-use annular suture, which is used to close an incision after a specific spine surgery known as nucleus pulposus removal. This surgery is performed on people with a condition called lumbar disc herniation, where the soft center of a spinal disc pushes out and can cause pain. The trial aims to find out if these sutures are safe and effective by looking at how well they work, the amount of pain patients experience, and any complications that may arise after the surgery.

To be eligible for this trial, participants need to be at least 18 years old, have been diagnosed with lumbar disc herniation, and have tried other treatments without success. They should have a certain level of pain and meet specific health criteria. If you join this study, you can expect to have your surgery with the new sutures and to be monitored for how well you heal and recover afterward. This trial is not yet recruiting participants, but it seeks to improve treatment options for those suffering from back pain due to this condition.

Gender

ALL

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.