Lumbar Intervertebral Disc Herniation

Not Applicable

• Conditions: Lumbar Disc Herniation
• Interventions: Procedure: Discectomy; Device: Dynamic Stabilization; Device: Instrumentation and fusion

• Registration Number: NCT02110186
• Lead Sponsor: Third Military Medical University

Brief Summary

The purpose of this study is to compare safety and outcomes of the following treatments of lumbar disc herniation: (1) discectomy with posterior dynamic stabilization with those of (2) discectomy alone or (3) discectomy with internal fixation and fusion.

Discectomy with posterior dynamic stabilization is proposed as the most effective treatment to improve range of motion, and to be similarly effective to discectomy alone and discectomy with internal fixation and fusion for other functional outcomes after surgery.

Detailed Description

The purpose of this study is to compare outcomes of (1) discectomy with posterior dynamic stabilization with those of (2) discectomy alone or (3) discectomy with internal fixation and fusion.

Study aims are:

1. To demonstrate superiority of discectomy with posterior dynamic stabilization over discectomy alone and discectomy with internal fixation and fusion in range of motion at the operated level;

2. To demonstrate non-inferiority of discectomy with posterior dynamic stabilization compared to discectomy alone and discectomy with internal fixation and fusion in functional outcomes as measured by change in Oswestry Disability Index;

3. To compare radiological, clinical, patient-reported and safety outcomes among the three surgical approaches.

Study Timeline

• Study Start: 2012-07
• Status Verified: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-07
• Last Update Submitted: 2014-04-07
• Study First Posted: 2014-04-10
• Last Update Posted: 2014-04-10
• Primary Completion: 2015-07
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• Signed informed consent

• Age between 20 and 60 years inclusive

• Radiographic evidence of single level lumbar disc herniation

• Scheduled for single-level lumbar discectomy with or without fusion or dynamic stabilization

• Preoperative ODI ≥ 30

• Clinical symptoms consistent with lumbar disc herniation determined by history or physical exam:

  • Radicular back or lower extremity pain and/or
  • Decreased muscular strength and/or
  • Abnormal sensation

• Involved disk at the spinal level between L2 and S1

• Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment, except in patients with severe symptoms that require immediate surgery (at surgeon's discretion)

• Absence of significant symptomatic adjacent segment disk herniation

Exclusion Criteria

• Cauda equine syndrome
• Previous spinal surgery, except previous discectomy at the same segment
• Patients with other lumbar conditions that will, in the opinion of the investigator, interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
• Osteoporosis defined as T-score ≤ -2.5. BMD will be measured by DEXA performed on lumbar spine
• Systemic infection such as AIDS, HIV, and active hepatitis
• Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance, which may impact the outcome or study participation
• Participation in a clinical trial of another investigational drug or device within the past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discectomy alone	Discectomy	Discectomy
Discectomy and fusion	Discectomy	Discectomy with internal fixation and fusion
Discectomy and dynamic stabilization	Dynamic Stabilization	Discectomy with posterior dynamic stabilization
Discectomy and dynamic stabilization	Discectomy	Discectomy with posterior dynamic stabilization
Discectomy and fusion	Instrumentation and fusion	Discectomy with internal fixation and fusion

Primary Outcome Measures

Name	Time	Method
Range of motion in sagittal plane at the operated level	24 months
Mean Change in Oswestry Disability Index (ODI)	Baseline, 24 months

Secondary Outcome Measures

Name	Time	Method
Change in Lumbar Pain Numeric Rating Scale (NRS)	Baseline, 24 months
Change in Leg Pain NRS	Baseline, 24 months

Trial Locations

Locations (1)

The Third Military Medical University/Southwest Hospital; 🇨🇳 Chongqing, China