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Lumbar Intervertebral Disc Herniation (LIDH)

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ClinicalTrials.gov Identifier: NCT02110186
Recruitment Status : Unknown
Verified April 2014 by Qiang Zhou, MD. PhD., Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : April 10, 2014
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Qiang Zhou, MD. PhD., Third Military Medical University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Device: Dynamic Stabilization Procedure: Discectomy Device: Instrumentation and fusion Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Comparative Study to Evaluate Effectiveness and Safety of Dynamic Stabilization in Treatment of Lumbar Disc Herniation
Study Start Date : July 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : June 2019

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Range of motion in sagittal plane at the operated level [ Time Frame: 24 months ]
  2. Mean Change in Oswestry Disability Index (ODI) [ Time Frame: Baseline, 24 months ]

Secondary Outcome Measures :
  1. Change in Lumbar Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, 24 months ]
  2. Change in Leg Pain NRS [ Time Frame: Baseline, 24 months ]

Other Outcome Measures:
  1. Change in SF-36 dimensions [ Time Frame: Baseline, 24 Months ]
  2. Radiographic Evaluations [ Time Frame: 24 months ]
  3. Time to occurrence and relationship to surgery of adverse events [ Time Frame: up to 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110186


Locations
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China
The Third Military Medical University/Southwest Hospital Recruiting
Chongqing, China
Contact: Qiang Zhou, MD, PhD    86-13677669899    zq_tlh@163.com   
Principal Investigator: Qiang Zhou, MD, PhD         
Sponsors and Collaborators
Third Military Medical University
More Information
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Responsible Party: Qiang Zhou, MD. PhD., Deputy Chair of the Department of Orthopedics, Chair of the Department of Spine Surgical Group, Third Military Medical University
ClinicalTrials.gov Identifier: NCT02110186    
Other Study ID Numbers: TMMU-ORTHO-2012-001
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014
Keywords provided by Qiang Zhou, MD. PhD., Third Military Medical University:
lumbar disc herniation
dynamic stabilization
discectomy with posterior dynamic stabilization
discectomy alone
discectomy with internal fixation and fusion
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Hernia
Pathological Conditions, Anatomical
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases