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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OON-15006018
Enrollment
Unknown
Registered
2015-02-03
Start date
2015-03-09
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Degenerative Diseases

Interventions

A:Posterior Dynamic Stabilization
B:Internal Fixation and Fusion

Sponsors

The first Affiliated Hospital of Third Military Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion 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: (1)Radicular back or lower extremity pain and/or (2)Decreased muscular strength and/or (3)Abnormal sensation. 7. Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The ROM of Lumbar;

Secondary

MeasureTime frame
Oswestry Disability Index (ODI);

Countries

China

Contacts

Public ContactZhou Qiang
zq_tlh@163.com+86 13677669899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026