Annulus repair with discectomy versus discectomy alone for lumbar disc herniation
Endoscopic Discectomy With Repair of Annulus Fibrosus Versus Discectomy Alone for Lumber Disc Herniation:A Prospective Multicenter Randomized Controlled Trial
This will test whether adding a small endoscopic annulus fibrosus repair to discectomy helps people with lumbar disc herniation recover better and have fewer re-herniations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital of Qingdao University Academic / other |
| Locations | 1 site (Qingdao) |
| Trial ID | NCT07250581 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study compares endoscopic discectomy plus annulus fibrosus (AF) suture repair versus endoscopic discectomy alone in patients with lumbar disc herniation. Eligible patients (ages 12–65, Pfirrmann grade I–II) who failed conservative care will be randomized to receive standard endoscopic nucleus removal with or without an AF suture device. The procedure is performed through spinal endoscopy using a dedicated AF repair tool, and outcomes will include recurrence rates, postoperative pain and function, and safety/adverse events. The trial aims to determine whether restoring annular integrity reduces re-herniation and related complications compared with discectomy alone.
Who should consider this trial
Good fit: Ideal candidates are people aged 12–65 with lumbar disc herniation (Pfirrmann I–II) whose symptoms persist after conservative treatment and who can attend long-term follow-up.
Not a fit: Patients with lumbar instability or spondylolisthesis, prior lumbar spine surgery, significant systemic disease, poor bone/metabolic status, or those unable to follow-up are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the procedure could lower re-herniation and reoperation rates and reduce postoperative pain and complications after endoscopic discectomy.
How similar studies have performed: Annulus repair has had mixed results historically in open surgery but recent large-scale clinical use of endoscopic AF suture devices shows promising early outcomes, though randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age: 12 years old to 65 years old, gender not limited; 2. Diagnosed with Lumbar disc herniation; 3. Preoperative intervertebral disc MRI Pfirrmann grade I - II; 4. Conservative treatment is ineffective, and the symptoms significantly affect life; 5. Be able to cooperate with long-term follow-up and sign the informed consent form. Exclusion Criteria: 1. Accompanied by lumbar spondylolisthesis, lumbar instability and other lumbar diseases, etc. 2. Previous history of lumbar spine surgery; 3. Those who have other major physical diseases and are unable to tolerate surgery; 4. Diseases such as malnutrition, abnormal bone metabolism, and autoimmune diseases that may affect the postoperative development process; 5. Unable to accept regular follow-up visitors
Where this trial is running
Qingdao
- Affiliated Hospital of Qingdao University — Qingdao, China (Recruiting)
Study contacts
- Study coordinator: xuexiao Ma
- Email: maxuexiaospinal@163.com
- Phone: 053282913568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.