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Status unknownNCT02110186LIDHUpdated Apr 10, 2014

Lumbar Intervertebral Disc Herniation

An interventional study of Dynamic Stabilization and Discectomy in Lumbar Disc Herniation, sponsored by Third Military Medical University. Status unknown at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-04-10.

Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
195
Allocation
Non-randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Lumbar Disc Herniation

Keywords

  • lumbar disc herniation
  • dynamic stabilization
  • discectomy with posterior dynamic stabilization
  • discectomy alone
  • discectomy with internal fixation and fusion
03

In context

Intervertebral Disc Displacement

478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.

This study's planned enrollment of 195 is above the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
195 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceDynamic Stabilization
  • ProcedureDiscectomy
  • DeviceInstrumentation and fusion
06

What researchers measure

Primary outcomes

  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 outcomes

  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 outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • The Third Military Medical University/Southwest Hospital
    Chongqing, China
    • Qiang Zhou, MD, PhD · Contact · zq_tlh@163.com · 86-13677669899
    • Qiang Zhou, MD, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02110186
Lead sponsor
Third Military Medical University
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) — Principal investigator
First posted
Apr 10, 2014
Start date
Jul 2012
Primary completion
Jul 2015 (estimated)
Completion
Jun 2019 (estimated)
Last update
Apr 10, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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