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

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%

The change of annulus cleft was evaluated according to annulus suture.Annular cleft reduction = annular cleft size before suture - annular cleft size after suture.

The change of annular tear reduction was assessed according to annular suture.Annulus cut reduction ratio = (size of annulus cut before unsutured - size of annulus cut after sutured)/size of annulus cut without suture *100%

Information on intraoperative blood loss was obtained from surgical records.

The time between assembly and completion of the suture from the single use of the ring suture.

After the subjects completed the 6-month post-operation interview, the researchers made the judgment. If the subjects met all the following evaluation criteria, they were recorded as "treatment success"; otherwise, they were "treatment failure".Evaluation criteria: 1) ODI index decreased by ≥10 points compared with pre-operation; 2) Compared with the preoperative results, the VAS score of lower extremities decreased by ≥2 points (if only one side was ≥4 points, that side was dominant; If both sides are ≥4 points, the average score of both sides is used to calculate the VAS score decline value); 3) No nerve root symptoms; 4) No second operation and/or other therapeutic intervention at the treated site after surgery; 5) MRI images showed no swelling or other abnormalities of clinical significance in the operative segment.

Treatment success rate = Number of successful cases/total cases *100%

According to their subjective feelings, the subjects were evaluated by Visual Analogue Scales (VAS). On a 10cm scale, "0" means painless and "10" means the most intense pain.

The SF-12 Health Questionnaire consists of 12 questions divided into 2 dimensions: physical health and mental health. Each question is set with different options, subjects according to their own feelings and actual situation, choose the most suitable option, each option corresponds to a different score. The score ranges from 0 to 100, with higher scores indicating better physical and mental health, and lower scores indicating worse physical and mental health.

ODI index includes 3 areas of single function, pain and individual comprehensive function, with a total of 10 items, the score range is 0 ~ 5 points, the total score is 50 points, the higher the score, the more serious the dysfunction of the subject.

The relapses of the subjects were closely observed and recorded by the researchers. If radiculopathy occurs and the MRI shows that the disc at the original surgical level has herniated again and is pressing on the nerve tissue, it can be considered a "recurrence." Recurrence rate = Number of recurrence cases/total cases ×100%.