Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy
NCT ID: NCT01204008
Last Updated: 2010-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2009-09-30
2015-12-31
Brief Summary
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Study hypothesis: The investigators believe that conservative discectomy could preserve a higher disc space and has a better long-term outcomes.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CS
conservative discectomy
conservative discectomy
a smaller incision with removal of the disc fragment with little invasion of the disc
AS
aggressive discectomy
a large open incision with aggressive removal of the disc fragments and curettage of the disc space
Interventions
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conservative discectomy
a smaller incision with removal of the disc fragment with little invasion of the disc
aggressive discectomy
a large open incision with aggressive removal of the disc fragments and curettage of the disc space
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
40 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Sun Yat-sen University
Principal Investigators
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Dongsheng Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-Sen memorial hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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zseyhds2
Identifier Type: -
Identifier Source: org_study_id