Status:
UNKNOWN
Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy
Lead Sponsor:
Sun Yat-sen University
Conditions:
Herniated Disc
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
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 ...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01204008
Start Date
September 1 2009
End Date
December 1 2015
Last Update
September 17 2010
Active Locations (1)
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1
Sun Yat-Sen memorial hospital
Guangzhou, Guangdong, China, 510120