A Randomized Trial of Annular Repair With Discectomy Versus Discectomy Alone for Lumbar Disc Herniation

NCT07250581 | Recruiting DMC

• 1 other identifier: QYFYEC2025-136
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Intervertebral Disc Herniation

Keywords

Annulus fibrosus repair; Lumbar intervertebral disc herniation; Spinal endoscopy

Outcome Measures

Primary Outcomes (4)

• 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.

  Within one year

• 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

  Within one year

• 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.

  Within one year

• 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.

  Within one year

Secondary Outcomes (1)

• Nerve injury

  Within one year

Study Arms (2)

Annulus fibrosus repair

EXPERIMENTAL

Annulus fibrosus repair, Suture the incision of the annulus fibrosus

Procedure: Repair of the annulus fibrosus

Non-annulus fibrosus repair

NO INTERVENTION

Non-annulus fibrosus repair, Do not suture the incision of the annulus fibrosus

Interventions

Repair of the annulus fibrosus PROCEDURE

Suture the incision of the annulus fibrosus

Annulus fibrosus repair

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Be able to cooperate with long-term follow-up and sign the informed consent form.

You may not qualify if:

• 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;
• Unable to accept regular follow-up visitors

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• 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

Study Sites (1)

Affiliated Hospital of Qingdao University

Qingdao, China

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

xuexiao Ma

CONTACT

053282913568; maxuexiaospinal@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endoscopic Discectomy with Repair of Annulus Fibrosus versus Discectomy Alone for Lumber Disc Herniation:A prospective Multicenter Randomized Controlled Trial

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: November 26, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-08

Locations

CN (1)