Clinical trial NCT02385695: Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spine Disc Degeneration
Keywords: Disc Degeneration Disease
DDD
multilevel lumbar Disc Degeneration Disease
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 102
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of The Third Medical University/Southwest Hospital with multilevel lumbar degenerative disk 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.

Eligibility criteria: 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

Primary outcomes:
measure: Range of Motion in Lumbar Spine
timeFrame: 24 Months
Secondary outcomes:
measure: Change in Oswestry Disability Index
timeFrame: 24 Months
Other outcomes:
measure: Numeric Rating Scale for Back Pain
timeFrame: 24 Months
measure: Numeric Rating Scale for Leg Pain
timeFrame: 24 Months
measure: Range of Motion in Sagittal Plane at Each Operated Level
timeFrame: 24 Months
measure: Radiographic Evaluations by Woodend Classification and Modic Changes on MRI
timeFrame: 24 Months
Locations:
city: Chongqing
country: China
facility: Third Military Medical University/Southwest Hospital
Study officials:
affiliation: Third Military Medical University
name: Qiang Zhou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: