Lumbar Intervertebral Disc Herniation

Lumbar Disc Herniation Clinical Trial

— LIDH  

Official title:

A Prospective, Comparative Study to Evaluate Effectiveness and Safety of Dynamic Stabilization in Treatment of Lumbar Disc Herniation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02110186
• Other study ID #: TMMU—ORTHO—2012—001
• Status: Recruiting
• Phase: N/A
• First received: April 7, 2014
• Last updated: April 7, 2014
• Start date: July 2012
• Est. completion date: June 2019

Study information

• Verified date: April 2014
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare safety and outcomes of the following treatments of lumbar disc herniation: (1) discectomy with posterior dynamic stabilization with those of (2) discectomy alone or (3) discectomy with internal fixation and fusion.

Discectomy with posterior dynamic stabilization is proposed as the most effective treatment to improve range of motion, and to be similarly effective to discectomy alone and discectomy with internal fixation and fusion for other functional outcomes after surgery.

Description:

The purpose of this study is to compare outcomes of (1) discectomy with posterior dynamic stabilization with those of (2) discectomy alone or (3) discectomy with internal fixation and fusion.

Study aims are:

1. To demonstrate superiority of discectomy with posterior dynamic stabilization over discectomy alone and discectomy with internal fixation and fusion in range of motion at the operated level;

2. To demonstrate non-inferiority of discectomy with posterior dynamic stabilization compared to discectomy alone and discectomy 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 among the three surgical approaches.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: June 2019
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Signed informed consent

• Age between 20 and 60 years inclusive

• Radiographic evidence of single level lumbar disc herniation

• Scheduled for single-level lumbar discectomy with or without fusion or dynamic stabilization

• Preoperative ODI = 30

• Clinical symptoms consistent with lumbar disc herniation determined by history or physical exam:

• Radicular back or lower extremity pain and/or

• Decreased muscular strength and/or

• Abnormal sensation

• Involved disk at the spinal level between L2 and S1

• Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment, except in patients with severe symptoms that require immediate surgery (at surgeon's discretion)

• Absence of significant symptomatic adjacent segment disk herniation

Exclusion Criteria:

• Cauda equine syndrome

• Previous spinal surgery, except previous discectomy at the same segment

• 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 = -2.5. BMD will be measured by DEXA performed on lumbar spine

• Systemic infection such as AIDS, HIV, 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 another investigational drug or device within the past 30 days

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Device:
• Dynamic Stabilization

Procedure:
• Discectomy

Device:
• Instrumentation and fusion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in SF-36 dimensions		Baseline, 24 Months	No
Other	Radiographic Evaluations		24 months	No
Other	Time to occurrence and relationship to surgery of adverse events		up to 24 months	Yes
Primary	Range of motion in sagittal plane at the operated level		24 months	No
Primary	Mean Change in Oswestry Disability Index (ODI)		Baseline, 24 months	No
Secondary	Change in Lumbar Pain Numeric Rating Scale (NRS)		Baseline, 24 months	No
Secondary	Change in Leg Pain NRS		Baseline, 24 months	No