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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-65
SponsorThe Affiliated Hospital of Qingdao University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Repair of the annulus fibrosus

    Procedure/Surgery

    Suture the incision of the annulus fibrosus

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Annulus fibrosus repairExperimental treatment 1 intervention
Group B: Non-annulus fibrosus repairNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Within one year
2

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

Time frame
Within one year
3

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.

Time frame
Within one year
4

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.

Time frame
Within one year

Secondary outcomes

1

Nerve injury

The proportion of postoperative nerve injury, including cases of sensory and motor nerve injury.

Time frame
Within one year

Other outcomes

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