Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Comparative Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease

Conditions
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Lumbar Spine Disc Degeneration

Intervention / Treatment
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* Procedure: Posterior Dynamic Stabilization
* Procedure: Internal Fixation and Fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Posterior Dynamic Stabilization<br>Surgical treatment with posterior dynamic stabilization | Procedure: Posterior Dynamic Stabilization<br> <br> |
| Internal Fixation and Fusion<br>Surgical treatment with internal fixation and fusion | Procedure: Internal Fixation and Fusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion in Lumbar Spine |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oswestry Disability Index |  | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disc Degeneration Disease, DDD, multilevel lumbar Disc Degeneration Disease