Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

This study is currently recruiting participants.
Verified August 2007 by Sun Yat-sen University
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01204008
First received: September 13, 2010
Last updated: September 16, 2010
Last verified: August 2007

September 13, 2010
September 16, 2010
September 2009
December 2012   (final data collection date for primary outcome measure)
  • patients satisfaction [ Time Frame: 6 weeks after intervention ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: 1st year after intervention ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: 3rd year after intervention ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: 5th year after intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01204008 on ClinicalTrials.gov Archive Site
  • recurrence rate of disc herniation [ Time Frame: 6 weeks after operation ] [ Designated as safety issue: No ]
  • recurrence rate of disc herniation [ Time Frame: 3 months after operation ] [ Designated as safety issue: No ]
  • recurrence rate of disc herniation [ Time Frame: 6 months after operation ] [ Designated as safety issue: No ]
  • recurrence rate of disc herniation [ Time Frame: 1st year after operation ] [ Designated as safety issue: No ]
  • recurrence rate of disc herniation [ Time Frame: 3rd year after operation ] [ Designated as safety issue: No ]
  • recurrence rate of disc herniation [ Time Frame: 5th year after operation ] [ Designated as safety issue: No ]
  • height of disc space [ Time Frame: 6 weeks after operation ] [ Designated as safety issue: No ]
  • height of disc space [ Time Frame: 3 months after operation ] [ Designated as safety issue: No ]
  • height of disc space [ Time Frame: 6 months after operation ] [ Designated as safety issue: No ]
  • height of disc operation [ Time Frame: 1st year after operation ] [ Designated as safety issue: No ]
  • height of disc space [ Time Frame: 3rd year after operation ] [ Designated as safety issue: No ]
  • height of disc space [ Time Frame: 5th year after operation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy
A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Herniated Disc
  • Procedure: conservative discectomy
    a smaller incision with removal of the disc fragment with little invasion of the disc
  • Procedure: aggressive discectomy
    a large open incision with aggressive removal of the disc fragments and curettage of the disc space
  • Experimental: CS
    conservative discectomy
    Intervention: Procedure: conservative discectomy
  • Active Comparator: AS
    Intervention: Procedure: aggressive discectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2015
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
No
Contact: Dongsheng Huang, MD. 00862081332553 huangdongshen18@hotmail.com
China
 
NCT01204008
zseyhds2
Yes
Dongsheng Huang, MD., Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Dongsheng Huang, MD Sun Yat-sen University
Sun Yat-sen University
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP