Annulus repair with discectomy versus discectomy alone for lumbar disc herniation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Affiliated Hospital of Qingdao University
  Qingdao, China Recruiting

Study contacts

• Study coordinator: xuexiao Ma
• Email: maxuexiaospinal@163.com
• Phone: 053282913568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.