Herniated Disc
Conditions
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.
Interventions
PROCEDUREconservative discectomy
a smaller incision with removal of the disc fragment with little invasion of the disc
PROCEDUREaggressive discectomy
a large open incision with aggressive removal of the disc fragments and curettage of the disc space
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| patients satisfaction | 6 weeks after intervention |
Secondary
| Measure | Time frame |
|---|---|
| recurrence rate of disc herniation | 6 weeks after operation |
| height of disc space | 6 weeks after operation |
| height of disc operation | 1st year after operation |
Countries
China
Contacts
Primary ContactDongsheng Huang, MD.
Outcome results
None listed