Lumbar Spine Disc Degeneration
Conditions
Keywords
Disc Degeneration Disease, DDD, multilevel lumbar Disc Degeneration Disease
Brief 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.
Detailed description
Study aims are: 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.
Interventions
PROCEDUREPosterior Dynamic Stabilization
PROCEDUREInternal Fixation and Fusion
Sponsors
Qiang Zhou, MD. PhD.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 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
1. Cauda equina syndrome 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Range of Motion in Lumbar Spine | 24 Months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Oswestry Disability Index | 24 Months |
Other
| Measure | Time frame |
|---|---|
| Numeric Rating Scale for Back Pain | 24 Months |
| Numeric Rating Scale for Leg Pain | 24 Months |
| Range of Motion in Sagittal Plane at Each Operated Level | 24 Months |
| Radiographic Evaluations by Woodend Classification and Modic Changes on MRI | 24 Months |
Countries
China
Contacts
Primary ContactQiang Zhou, MD, PhD
Backup ContactBranko Kopjar, MD, PhD
Outcome results
None listed