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

• Conditions: Lumbar Spine Disc Degeneration
• Interventions: Procedure: Internal Fixation and Fusion; Procedure: Posterior Dynamic Stabilization

• Registration Number: NCT02385695
• Lead Sponsor: Qiang Zhou, MD. PhD.

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.

Study Timeline

• Study First Submitted: 2015-02-26
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-28
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Internal Fixation and Fusion	Internal Fixation and Fusion	Surgical treatment with internal fixation and fusion
Posterior Dynamic Stabilization	Posterior Dynamic Stabilization	Surgical treatment with posterior dynamic stabilization

Primary Outcome Measures

Name	Time	Method
Range of Motion in Lumbar Spine	24 Months

Secondary Outcome Measures

Name	Time	Method
Change in Oswestry Disability Index	24 Months

Trial Locations

Locations (1)

Third Military Medical University/Southwest Hospital; 🇨🇳 Chongqing, China