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

Lumbar Spine Disc Degeneration Clinical Trial

— MLIDH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02385695
• Other study ID #: Scientific Research 2015 (06)
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2015
• Last updated: September 24, 2015
• Start date: March 2015
• Est. completion date: August 2021

Study information

• Verified date: September 2015
• Source: Third Military Medical University
• Contact: Qiang Zhou, MD, PhD
• Phone: 86-13677669899
• Email: zq_tlh[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Spine Disc Degeneration

Intervention

Procedure:
• Posterior Dynamic Stabilization

• Internal Fixation and Fusion

Locations

Country	Name	City	State
China	Third Military Medical University/Southwest Hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Qiang Zhou, MD. PhD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numeric Rating Scale for Back Pain		24 Months	No
Other	Numeric Rating Scale for Leg Pain		24 Months	No
Other	Range of Motion in Sagittal Plane at Each Operated Level		24 Months	No
Other	Radiographic Evaluations by Woodend Classification and Modic Changes on MRI		24 Months	No
Primary	Range of Motion in Lumbar Spine		24 Months	No
Secondary	Change in Oswestry Disability Index		24 Months	No