About this trial
The goal of this study is to explore the indications and application scope of spinal endoscopy combined with annulus fibrosus repair technology, with a focus on verifying the effectiveness of annulus fibrosus suture technology and evaluating its safety, so as to further support the promotion of annulus fibrosus repair technology in patients with lumbar disc herniation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 12 years old to 65 years old, gender not limited;
Diagnosed with Lumbar disc herniation;
Preoperative intervertebral disc MRI Pfirrmann grade I - II;
Conservative treatment is ineffective, and the symptoms significantly affect life;
Disqualifiers
Accompanied by lumbar spondylolisthesis, lumbar instability and other lumbar diseases, etc.
Previous history of lumbar spine surgery;
Those who have other major physical diseases and are unable to tolerate surgery;
Diseases such as malnutrition, abnormal bone metabolism, and autoimmune diseases that may affect the postoperative development process;
Trial design
Parallel
Treatments tested in this trial
Repair of the annulus fibrosus
Procedure/SurgerySuture the incision of the annulus fibrosus
Treatment groups
Trial outcomes
Primary outcomes
Recurrence rate
The proportion of lumbar intervertebral disc protrusion recurring at the surgical segment within a certain period after surgery, including short-term recurrence and long-term recurrence.
Postoperative therapeutic effect
The change of the quality of life of postoperative patients was evaluated by using the VAS(Visual Analog Score), Zero to ten points indicates the degree of pain from mild to severe
Postoperative therapeutic effect
The change of the quality of life of postoperative patients was evaluated by using the JOA score(Japanese Orthopaedic Association), In the JOA score, a range from 0 to 29 points is interpreted as indicating a progression from poor to good.
Postoperative therapeutic effect
The change of the quality of life of postoperative patients was evaluated by using the ODI (Oswestry Disability Index), 0% represents the least severe condition, while 100% indicates the most severe condition.
Secondary outcomes
Nerve injury
The proportion of postoperative nerve injury, including cases of sensory and motor nerve injury.
Sponsors and contacts
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The Affiliated Hospital of Qingdao University
Lead sponsor
Qilu Hospital of Shandong University
Collaborator
Shandong Provincial Hospital
Collaborator
Qianfoshan Hospital
Collaborator
Peking Union Medical College Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborator