Lumbar Disc HerniationLIDHNCT02110186
Lumbar Intervertebral Disc Herniation
A study testing Dynamic Stabilization, Discectomy and Instrumentation and fusion in people with Lumbar Disc Herniation, run by Third Military Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Dynamic Stabilization, Discectomy and Instrumentation and fusion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Military Medical University/Southwest Hospital
Chongqing
Qiang Zhou, MD, PhD, 86-13677669899, zq_tlh@163.com
Qiang Zhou, MD, PhD
About this study
Official title: 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.
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:
- 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;
- 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;
- To compare radiological, clinical, patient-reported and safety outcomes among the three surgical approaches.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Dynamic Stabilization, Discectomy, Instrumentation and fusion
- Keywords
- lumbar disc herniation, dynamic stabilization, discectomy with posterior dynamic stabilization, discectomy alone, discectomy with internal fixation and fusion
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic StabilizationDevice
DiscectomyProcedure or surgery
Instrumentation and fusionDevice
| Study group | Role | What they receive |
|---|---|---|
| Discectomy and dynamic stabilization | Experimental | Discectomy with posterior dynamic stabilization Receives: Device: Dynamic Stabilization; Procedure: Discectomy |
| Discectomy alone | Active comparator | Discectomy Receives: Procedure: Discectomy |
| Discectomy and fusion | Active comparator | Discectomy with internal fixation and fusion Receives: Procedure: Discectomy; Device: Instrumentation and fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion in sagittal plane at the operated level
Measured: 24 months
Mean Change in Oswestry Disability Index (ODI)
Measured: Baseline, 24 months
Secondary outcomes (2)
Change in Lumbar Pain Numeric Rating Scale (NRS)
Measured: Baseline, 24 months
Change in Leg Pain NRS
Measured: Baseline, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJul 2012
- Primary completionJul 2015 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Zhou, MD. PhD., Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110186
- Sponsor's protocol ID
- TMMU-ORTHO-2012-001
- Acronym
- LIDH
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Comparative Study to Evaluate Effectiveness and Safety of Dynamic Stabilization in Treatment of Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT02110186
- Acronym / sponsor ID
- LIDH / TMMU-ORTHO-2012-001
- Conditions
- Lumbar Disc Herniation
- Keywords
- lumbar disc herniation, dynamic stabilization, discectomy with posterior dynamic stabilization, discectomy alone, discectomy with internal fixation and fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- To compare radiological, clinical, patient-reported and safety outcomes among the three surgical approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Discectomy and dynamic stabilization | Experimental | Device: Dynamic Stabilization, Procedure: DiscectomyDiscectomy with posterior dynamic stabilization |
| Discectomy alone | Active comparator | Procedure: DiscectomyDiscectomy |
| Discectomy and fusion | Active comparator | Procedure: Discectomy, Device: Instrumentation and fusionDiscectomy with internal fixation and fusion |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Stabilization | Device | Discectomy and dynamic stabilization |
| Discectomy | Procedure or surgery | Discectomy alone, Discectomy and dynamic stabilization, Discectomy and fusion |
| Instrumentation and fusion | Device | Discectomy and fusion |
Primary outcome
Range of motion in sagittal plane at the operated level
Time frame: 24 months
Mean Change in Oswestry Disability Index (ODI)
Time frame: Baseline, 24 months
2 secondary outcomes
Change in Lumbar Pain Numeric Rating Scale (NRS)
Time frame: Baseline, 24 months
Change in Leg Pain NRS
Time frame: Baseline, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Third Military Medical University/Southwest Hospital
Chongqing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Stabilization, Discectomy and Instrumentation and fusion in people with Lumbar Disc Herniation, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion in sagittal plane at the operated level (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014; AzTrials last refreshed its copy on 27 Oct 2026.