Lumbar Spine Disc DegenerationMLIDHNCT02385695
Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease
An observational study of Lumbar Spine Disc Degeneration, run by Qiang Zhou, MD. PhD. at 1 site in China.
Trial summary
The purpose of this study is to compare outcomes of (i) surgical treatment with posterior dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in patients with multilevel lumbar degenerative disk disease. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Lumbar Spine Disc Degeneration
- What is being tested?
- Posterior Dynamic Stabilization and Internal Fixation and Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Aug 2021
- Phase
- Observational
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of The Third Medical University/Southwest Hospital with multilevel lumbar degenerative disk disease.
Who may be able to join
- Signed informed consent
- Age between 30 and 75 years inclusive
- Radiographic evidence of multi-level lumbar disc degeneration disease
- Scheduled for 2- or 3-level lumbar discectomy at levels from L1 to S1 with or without dynamic stabilization or fusion
- Preoperative ODI ≥ 30%
- Clinical symptoms consistent with diagnosis of lumbar DDD:
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- Radicular back or lower extremity pain and/or
- Decreased muscular strength and/or
- Abnormal sensation
- Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment
Who cannot join
- Cauda equina syndrome
- 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 ≤ -3.5. BMD will be measured by DEXA performed on lumbar spine
- Systemic infection such as AIDS 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 investigational drug or device within the past 30 days
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
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 Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease
The purpose of this study is to compare outcomes of (i) surgical treatment with posterior dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in patients with multilevel lumbar degenerative disk disease.
Read the detailed description
Study aims are:
- To evaluate superiority of Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in lumbar range of motion;
- To compare Surgical treatment with posterior dynamic stabilization compared to Surgical treatment 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 between the two surgical approaches.
- Conditions
- Lumbar Spine Disc Degeneration
- Being tested
- Posterior Dynamic Stabilization, Internal Fixation and Fusion
- Keywords
- Disc Degeneration Disease, DDD, multilevel lumbar Disc Degeneration Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Dynamic StabilizationProcedure or surgery
Internal Fixation and FusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Posterior Dynamic Stabilization | Surgical treatment with posterior dynamic stabilization Receives: Procedure: Posterior Dynamic Stabilization | |
| Internal Fixation and Fusion | Surgical treatment with internal fixation and fusion Receives: Procedure: Internal Fixation and Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion in Lumbar Spine
Measured: 24 Months
Secondary outcomes (1)
Change in Oswestry Disability Index
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine Disc DegenerationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiang Zhou, MD. PhD.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiang Zhou, MD. PhD., Third Military Medical University
- Investigators
- Qiang Zhou, MD, PhD, Principal investigator, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385695
- Sponsor's protocol ID
- Scientific Research 2015 (06)
- Acronym
- MLIDH
- Status last verified
- Sep 2015
- First submitted
- 26 Feb 2015
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease
- ClinicalTrials.gov ID
- NCT02385695
- Acronym / sponsor ID
- MLIDH / Scientific Research 2015 (06)
- Conditions
- Lumbar Spine Disc Degeneration
- Keywords
- Disc Degeneration Disease, DDD, multilevel lumbar Disc Degeneration Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Qiang Zhou, MD. PhD.University, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 11 Mar 2015 (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 outcomes of (i) surgical treatment with posterior dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in patients with multilevel lumbar degenerative disk disease.
Detailed description
Study aims are:
- To evaluate superiority of Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in lumbar range of motion;
- To compare Surgical treatment with posterior dynamic stabilization compared to Surgical treatment 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 between the two surgical approaches.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior Dynamic Stabilization | – | Procedure: Posterior Dynamic StabilizationSurgical treatment with posterior dynamic stabilization |
| Internal Fixation and Fusion | – | Procedure: Internal Fixation and FusionSurgical treatment with internal fixation and fusion |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of The Third Medical University/Southwest Hospital with multilevel lumbar degenerative disk disease.
Key inclusion criteria (10 listed)
- Signed informed consent
- Age between 30 and 75 years inclusive
- Radiographic evidence of multi-level lumbar disc degeneration disease
- Scheduled for 2- or 3-level lumbar discectomy at levels from L1 to S1 with or without dynamic stabilization or fusion
- Preoperative ODI ≥ 30%
Key exclusion criteria (6 listed)
- Cauda equina syndrome
- 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 ≤ -3.5. BMD will be measured by DEXA performed on lumbar spine
- Systemic infection such as AIDS 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
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 |
|---|---|---|
| Posterior Dynamic Stabilization | Procedure or surgery | Posterior Dynamic Stabilization |
| Internal Fixation and Fusion | Procedure or surgery | Internal Fixation and Fusion |
Primary outcome
Range of Motion in Lumbar Spine
Time frame: 24 Months
1 secondary outcome
Change in Oswestry Disability Index
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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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.
Qiang Zhou, MD, PhD principal investigator
Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spine Disc Degeneration, run by Qiang Zhou, MD. PhD. 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 10 inclusion and 6 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 28 Sep 2015. 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?
Contact Qiang Zhou, MD, PhD (86-13677669899, zq_tlh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion in Lumbar Spine (time frame: 24 Months). 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 28 Sep 2015.