Patients with intervertebral disc herniation were sutured with annulus fibrosus incision after nucleus pulposus removal
Conditions
Interventions
Disposable fibrous ring sutures:Use a disposable annulus suture device for annulus suture
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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 Pfirrman 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of suture; | — |
Secondary
| Measure | Time frame |
|---|---|
| Annulus fibril cleft decreased in value;Reduced proportion of annular fibril cleft;Intraoperative blood loss;Suture time;Treatment success rate;VAS pain score (lower back, bilateral lower limbs);SF-12 rating;ODI index;Instrument defect;Product operation satisfaction; | — |
Countries
China
Contacts
Public ContactWeihong Xu
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed