Clinical trial NCT02110186: Lumbar Intervertebral Disc Herniation
Official title: A Prospective, Comparative Study to Evaluate Effectiveness and Safety of Dynamic Stabilization in Treatment of Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: lumbar disc herniation
dynamic stabilization
discectomy with posterior dynamic stabilization
discectomy alone
discectomy with internal fixation and fusion
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 195
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Range of motion in sagittal plane at the operated level
timeFrame: 24 months
measure: Mean Change in Oswestry Disability Index (ODI)
timeFrame: Baseline, 24 months
Secondary outcomes:
measure: Change in Lumbar Pain Numeric Rating Scale (NRS)
timeFrame: Baseline, 24 months
measure: Change in Leg Pain NRS
timeFrame: Baseline, 24 months
Other outcomes:
measure: Change in SF-36 dimensions
timeFrame: Baseline, 24 Months
measure: Radiographic Evaluations
timeFrame: 24 months
measure: Time to occurrence and relationship to surgery of adverse events
timeFrame: up to 24 months
Locations:
city: Chongqing
country: China
facility: The Third Military Medical University/Southwest Hospital
Study officials:
References: