NCT02110186

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

3 years

First QC Date

April 7, 2014

Last Update Submit

April 7, 2014

Conditions

Lumbar Disc Herniation

Keywords

lumbar disc herniationdynamic stabilizationdiscectomy with posterior dynamic stabilizationdiscectomy alonediscectomy with internal fixation and fusion

Outcome Measures

Primary Outcomes (2)

  • Range of motion in sagittal plane at the operated level

    24 months

  • Mean Change in Oswestry Disability Index (ODI)

    Baseline, 24 months

Secondary Outcomes (2)

  • Change in Lumbar Pain Numeric Rating Scale (NRS)

    Baseline, 24 months

  • Change in Leg Pain NRS

    Baseline, 24 months

Other Outcomes (3)

  • Change in SF-36 dimensions

    Baseline, 24 Months

  • Radiographic Evaluations

    24 months

  • Time to occurrence and relationship to surgery of adverse events

    up to 24 months

Study Arms (3)

Discectomy and dynamic stabilization

EXPERIMENTAL

Discectomy with posterior dynamic stabilization

Device: Dynamic StabilizationProcedure: Discectomy

Discectomy alone

ACTIVE COMPARATOR

Discectomy

Procedure: Discectomy

Discectomy and fusion

ACTIVE COMPARATOR

Discectomy with internal fixation and fusion

Procedure: DiscectomyDevice: Instrumentation and fusion

Interventions

Dynamic StabilizationDEVICE
Discectomy and dynamic stabilization
DiscectomyPROCEDURE
Discectomy aloneDiscectomy and dynamic stabilizationDiscectomy and fusion
Instrumentation and fusionDEVICE
Discectomy and fusion

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Military Medical University/Southwest Hospital

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Diskectomy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chair of the Department of Orthopedics, Chair of the Department of Spine Surgical Group

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 10, 2014

Study Start

July 1, 2012

Primary Completion

July 1, 2015

Study Completion

June 1, 2019

Last Updated

April 10, 2014

Record last verified: 2014-04

Locations

CN(1)