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Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Herniated Disc Procedure: conservative discectomy Procedure: aggressive discectomy Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy
Study Start Date : September 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: CS
conservative discectomy
 Procedure: conservative discectomy
a smaller incision with removal of the disc fragment with little invasion of the disc
Active Comparator: AS Procedure: aggressive discectomy
a large open incision with aggressive removal of the disc fragments and curettage of the disc space


Outcome Measures
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Primary Outcome Measures :
  1. patients satisfaction [ Time Frame: 6 weeks after intervention ]
  2. patients satisfaction [ Time Frame: 3 months after intervention ]
  3. patients satisfaction [ Time Frame: 6 months after intervention ]
  4. patients satisfaction [ Time Frame: 1st year after intervention ]
  5. patients satisfaction [ Time Frame: 3rd year after intervention ]
  6. patients satisfaction [ Time Frame: 5th year after intervention ]

Secondary Outcome Measures :
  1. recurrence rate of disc herniation [ Time Frame: 6 weeks after operation ]
  2. recurrence rate of disc herniation [ Time Frame: 3 months after operation ]
  3. recurrence rate of disc herniation [ Time Frame: 6 months after operation ]
  4. recurrence rate of disc herniation [ Time Frame: 1st year after operation ]
  5. recurrence rate of disc herniation [ Time Frame: 3rd year after operation ]
  6. recurrence rate of disc herniation [ Time Frame: 5th year after operation ]
  7. height of disc space [ Time Frame: 6 weeks after operation ]
  8. height of disc space [ Time Frame: 3 months after operation ]
  9. height of disc space [ Time Frame: 6 months after operation ]
  10. height of disc operation [ Time Frame: 1st year after operation ]
  11. height of disc space [ Time Frame: 3rd year after operation ]
  12. height of disc space [ Time Frame: 5th year after operation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204008


Contacts
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Contact: Dongsheng Huang, MD. 00862081332553 huangdongshen18@hotmail.com

Locations
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China, Guangdong
Sun Yat-Sen memorial hospital Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Dongsheng Huang, MD    00862081332553    huangdongshen18@hotmail.com   
Principal Investigator: Dongsheng Huang, MD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Dongsheng Huang, MD Sun Yat-sen University
More Information
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Responsible Party: Dongsheng Huang, MD., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01204008     History of Changes
Other Study ID Numbers: zseyhds2
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: September 17, 2010
Last Verified: August 2007
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
 Hernia
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases