Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease
NCT ID: NCT02385695
Last Updated: 2015-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
102 participants
OBSERVATIONAL
2015-03-31
2021-08-31
Brief Summary
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Detailed Description
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1. To evaluate superiority of Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in lumbar range of motion;
2. 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;
3. To compare radiological, clinical, patient-reported and, safety outcomes between the two surgical approaches.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Posterior Dynamic Stabilization
Surgical treatment with posterior dynamic stabilization
Posterior Dynamic Stabilization
Internal Fixation and Fusion
Surgical treatment with internal fixation and fusion
Internal Fixation and Fusion
Interventions
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Posterior Dynamic Stabilization
Internal Fixation and Fusion
Eligibility Criteria
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Inclusion Criteria
2. Age between 30 and 75 years inclusive
3. Radiographic evidence of multi-level lumbar disc degeneration disease
4. Scheduled for 2- or 3-level lumbar discectomy at levels from L1 to S1 with or without dynamic stabilization or fusion
5. Preoperative ODI ≥ 30%
6. Clinical symptoms consistent with diagnosis of lumbar DDD:
* Radicular back or lower extremity pain and/or
* Decreased muscular strength and/or
* Abnormal sensation
7. Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment
Exclusion Criteria
2. 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)
3. Osteoporosis defined as T-score ≤ -3.5. BMD will be measured by DEXA performed on lumbar spine
4. Systemic infection such as AIDS and active hepatitis
5. Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance, which may impact the outcome or study participation
6. Participation in a clinical trial of investigational drug or device within the past 30 days
30 Years
75 Years
ALL
No
Sponsors
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Qiang Zhou, MD. PhD.
OTHER
Responsible Party
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Qiang Zhou, MD. PhD.
Deputy Chair of the Department of Orthopedics, Chair of the Department of Spine Surgical Group
Principal Investigators
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Qiang Zhou, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Third Military Medical University
Locations
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Third Military Medical University/Southwest Hospital
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Scientific Research 2015 (06)
Identifier Type: -
Identifier Source: org_study_id
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