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Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01204008
Recruitment Status : Unknown
Verified August 2007 by Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : September 17, 2010
Last Update Posted : September 17, 2010
Sponsor:
Information provided by:
Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE September 13, 2010
First Posted Date  ICMJE September 17, 2010
Last Update Posted Date September 17, 2010
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2010)
  • patients satisfaction [ Time Frame: 6 weeks after intervention ]
  • patients satisfaction [ Time Frame: 3 months after intervention ]
  • patients satisfaction [ Time Frame: 6 months after intervention ]
  • patients satisfaction [ Time Frame: 1st year after intervention ]
  • patients satisfaction [ Time Frame: 3rd year after intervention ]
  • patients satisfaction [ Time Frame: 5th year after intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2010)
  • recurrence rate of disc herniation [ Time Frame: 6 weeks after operation ]
  • recurrence rate of disc herniation [ Time Frame: 3 months after operation ]
  • recurrence rate of disc herniation [ Time Frame: 6 months after operation ]
  • recurrence rate of disc herniation [ Time Frame: 1st year after operation ]
  • recurrence rate of disc herniation [ Time Frame: 3rd year after operation ]
  • recurrence rate of disc herniation [ Time Frame: 5th year after operation ]
  • height of disc space [ Time Frame: 6 weeks after operation ]
  • height of disc space [ Time Frame: 3 months after operation ]
  • height of disc space [ Time Frame: 6 months after operation ]
  • height of disc operation [ Time Frame: 1st year after operation ]
  • height of disc space [ Time Frame: 3rd year after operation ]
  • height of disc space [ Time Frame: 5th year after operation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy
Official Title  ICMJE A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Herniated Disc
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: CS
    conservative discectomy
    Intervention: Procedure: conservative discectomy
  • Active Comparator: AS
    Intervention: Procedure: aggressive discectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 16, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01204008
Other Study ID Numbers  ICMJE zseyhds2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dongsheng Huang, MD., Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dongsheng Huang, MD Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date August 2007

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