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.
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;
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;
Active local or systemic infection;
Patients with lumbar tumors and/or spinal malformations;
Imaging showed calcification of the posterior longitudinal ligament;
Single group
Disposable fibrous ring sutures
DeviceA new disposable fibrous ring suture device developed and produced by 2020 (Beijing) Medical Technology Co., Ltd
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%
Annulus fibril cleft decreased in value
The change of annulus cleft was evaluated according to annulus suture.Annular cleft reduction = annular cleft size before suture - annular cleft size after suture.
Reduced proportion of annular fibril cleft
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%
Intraoperative blood loss
Information on intraoperative blood loss was obtained from surgical records.
Suture time
The time between assembly and completion of the suture from the single use of the ring suture.
Recurrence rate
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%.
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Suzhou Care-Real Medical Technology Co., Ltd.
Lead sponsor
2020 (Beijing) Medical Technology Co., Ltd
Collaborator
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