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Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

Primary Purpose

Herniated Disc

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
conservative discectomy
aggressive discectomy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herniated Disc

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Duration of symptoms: 6 or more weeks.
  • Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy.
  • Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising.
  • Tests: MRI to confirm diagnosis and level(s).

Exclusion Criteria:

  • Previous lumbar spine surgery.
  • Not a surgical candidate for any of these reasons: Overall health which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months.
  • Possible pregnancy.
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no clinical signs or symptoms of the malignancy for at least 5 years.
  • Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
  • Age less than 18 years.
  • Cauda Equina syndrome or progressive neurological deficit (usually requiring urgent surgery).
  • Unavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys.
  • Symptoms less than 6 weeks.
  • Patient currently enrolled in any experimental "spine related" study.

Sites / Locations

  • Sun Yat-Sen memorial hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CS

AS

Arm Description

conservative discectomy

Outcomes

Primary Outcome Measures

patients satisfaction
patients satisfaction
patients satisfaction
patients satisfaction
patients satisfaction
patients satisfaction

Secondary Outcome Measures

recurrence rate of disc herniation
recurrence rate of disc herniation
recurrence rate of disc herniation
recurrence rate of disc herniation
recurrence rate of disc herniation
recurrence rate of disc herniation
height of disc space
height of disc space
height of disc space
height of disc operation
height of disc space
height of disc space

Full Information

First Posted
September 13, 2010
Last Updated
September 16, 2010
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01204008
Brief Title
Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy
Official Title
A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Summary: This is a prospective randomize study to compare conservative and aggressive discectomy for treatment of disc herniation with radiculopathy. Study hypothesis: The investigators believe that conservative discectomy could preserve a higher disc space and has a better long-term outcomes.
Detailed Description
objectives:to compare the effect of two type surgery(conservative discectomy and aggressive discectomy)on disc herniation with radiculopathy after long-term follow-up. methods:the patients who were confirmed suffer from disc herniation with radiculopathy and failed to nonsurgical treatment will be divided into two groups, and will be follow up 3~6 years for seeking the effect on disc space preservation and recurrent. outcome measures:the rate of pain release and patients satisfaction were measured by SF-36,ODI,VAS,score post-OP. the height of disc was measured on X-ray film by the end point.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herniated Disc

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CS
Arm Type
Experimental
Arm Description
conservative discectomy
Arm Title
AS
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
conservative discectomy
Intervention Description
a smaller incision with removal of the disc fragment with little invasion of the disc
Intervention Type
Procedure
Intervention Name(s)
aggressive discectomy
Intervention Description
a large open incision with aggressive removal of the disc fragments and curettage of the disc space
Primary Outcome Measure Information:
Title
patients satisfaction
Time Frame
6 weeks after intervention
Title
patients satisfaction
Time Frame
3 months after intervention
Title
patients satisfaction
Time Frame
6 months after intervention
Title
patients satisfaction
Time Frame
1st year after intervention
Title
patients satisfaction
Time Frame
3rd year after intervention
Title
patients satisfaction
Time Frame
5th year after intervention
Secondary Outcome Measure Information:
Title
recurrence rate of disc herniation
Time Frame
6 weeks after operation
Title
recurrence rate of disc herniation
Time Frame
3 months after operation
Title
recurrence rate of disc herniation
Time Frame
6 months after operation
Title
recurrence rate of disc herniation
Time Frame
1st year after operation
Title
recurrence rate of disc herniation
Time Frame
3rd year after operation
Title
recurrence rate of disc herniation
Time Frame
5th year after operation
Title
height of disc space
Time Frame
6 weeks after operation
Title
height of disc space
Time Frame
3 months after operation
Title
height of disc space
Time Frame
6 months after operation
Title
height of disc operation
Time Frame
1st year after operation
Title
height of disc space
Time Frame
3rd year after operation
Title
height of disc space
Time Frame
5th year after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Duration of symptoms: 6 or more weeks. Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy. Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising. Tests: MRI to confirm diagnosis and level(s). Exclusion Criteria: Previous lumbar spine surgery. Not a surgical candidate for any of these reasons: Overall health which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months. Possible pregnancy. Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no clinical signs or symptoms of the malignancy for at least 5 years. Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine. Age less than 18 years. Cauda Equina syndrome or progressive neurological deficit (usually requiring urgent surgery). Unavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys. Symptoms less than 6 weeks. Patient currently enrolled in any experimental "spine related" study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongsheng Huang, MD.
Phone
00862081332553
Email
huangdongshen18@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongsheng Huang, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen memorial hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongsheng Huang, MD
Phone
00862081332553
Email
huangdongshen18@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dongsheng Huang, MD

12. IPD Sharing Statement

Learn more about this trial

Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

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