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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Spine Disc Degeneration
• Intervention / Treatment: Procedure: Posterior Dynamic Stabilization; Procedure: Internal Fixation and Fusion

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 Type: Observational
• Enrollment (Anticipated): 102

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • Third Military Medical University/Southwest Hospital
    • Contact: Qiang Zhou, MD, PhD; Phone Number: 86-13677669899; Email: zq_tlh@163.com
    • Principal Investigator: Qiang Zhou, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of The Third Medical University/Southwest Hospital with multilevel lumbar degenerative disk disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Posterior Dynamic Stabilization; Surgical treatment with posterior dynamic stabilization	Procedure: Posterior Dynamic Stabilization
Internal Fixation and Fusion; Surgical treatment with internal fixation and fusion	Procedure: Internal Fixation and Fusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Oswestry Disability Index	24 Months

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Qiang Zhou, MD. PhD.
• Investigators: Principal Investigator: Qiang Zhou, MD, PhD, Third Military Medical University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 5, 2015
• First Posted (Estimate): March 11, 2015

Study Record Updates

• Last Update Posted (Estimate): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: DDD; Disc Degeneration Disease; multilevel lumbar Disc Degeneration Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: Scientific Research 2015 (06)