Lumbar Intervertebral Disc Herniation

NCT ID: NCT02110186

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2019-06-30

Brief 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.

Detailed 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.

Conditions

Lumbar Disc Herniation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Discectomy and dynamic stabilization

Discectomy with posterior dynamic stabilization

Group Type: EXPERIMENTAL

Dynamic Stabilization

Intervention Type: DEVICE

Discectomy

Intervention Type: PROCEDURE

Discectomy alone

Discectomy

Group Type: ACTIVE_COMPARATOR

Discectomy

Intervention Type: PROCEDURE

Discectomy and fusion

Discectomy with internal fixation and fusion

Group Type: ACTIVE_COMPARATOR

Discectomy

Intervention Type: PROCEDURE

Instrumentation and fusion

Intervention Type: DEVICE

Interventions

Dynamic Stabilization

Intervention Type: DEVICE

Discectomy

Intervention Type: PROCEDURE

Instrumentation and fusion

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qiang Zhou, MD. PhD.

Deputy Chair of the Department of Orthopedics, Chair of the Department of Spine Surgical Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Third Military Medical University/Southwest Hospital

Chongqing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qiang Zhou, MD, PhD

Role: primary

zq_tlh@163.com

86-13677669899

Other Identifiers

TMMU-ORTHO-2012-001

Identifier Type: -

Identifier Source: org_study_id