Lumbar Intervertebral Disc Herniation (LIDH)

A Prospective, Comparative Study to Evaluate Effectiveness and Safety of Dynamic Stabilization in Treatment of Lumbar Disc Herniation

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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Device: Dynamic Stabilization; Procedure: Discectomy; Device: Instrumentation and fusion

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 Type: Interventional
• Enrollment (Anticipated): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • The Third Military Medical University/Southwest Hospital
    • Contact: Qiang Zhou, MD, PhD; Phone Number: 86-13677669899; Email: zq_tlh@163.com
    • Principal Investigator: Qiang Zhou, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Discectomy and dynamic stabilization; Discectomy with posterior dynamic stabilization	Device: Dynamic Stabilization; Procedure: Discectomy
Active Comparator: Discectomy alone; Discectomy	Procedure: Discectomy
Active Comparator: Discectomy and fusion; Discectomy with internal fixation and fusion	Procedure: Discectomy; Device: Instrumentation and fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Change in Lumbar Pain Numeric Rating Scale (NRS)	Baseline, 24 months
Change in Leg Pain NRS	Baseline, 24 months

Other Outcome Measures

Outcome Measure	Time Frame
Change in SF-36 dimensions	Baseline, 24 Months
Radiographic Evaluations	24 months
Time to occurrence and relationship to surgery of adverse events	up to 24 months

Collaborators and Investigators

• Sponsor: Third Military Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): April 10, 2014
• Last Update Submitted That Met QC Criteria: April 7, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: lumbar disc herniation; dynamic stabilization; discectomy with posterior dynamic stabilization; discectomy alone; discectomy with internal fixation and fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: TMMU-ORTHO-2012-001