Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy

Conditions
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Herniated Disc

Intervention / Treatment
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* Procedure: conservative discectomy
* Procedure: aggressive discectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS<br>conservative discectomy | Procedure: conservative discectomy<br>* a smaller incision with removal of the disc fragment with little invasion of the disc<br>|
| Active Comparator: AS<br> | Procedure: aggressive discectomy<br>* a large open incision with aggressive removal of the disc fragments and curettage of the disc space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients satisfaction |  | 6 weeks after intervention | 
| patients satisfaction |  | 3 months after intervention | 
| patients satisfaction |  | 6 months after intervention | 
| patients satisfaction |  | 1st year after intervention | 
| patients satisfaction |  | 3rd year after intervention | 
| patients satisfaction |  | 5th year after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate of disc herniation |  | 6 weeks after operation | 
| recurrence rate of disc herniation |  | 3 months after operation | 
| recurrence rate of disc herniation |  | 6 months after operation | 
| recurrence rate of disc herniation |  | 1st year after operation | 
| recurrence rate of disc herniation |  | 3rd year after operation | 
| recurrence rate of disc herniation |  | 5th year after operation | 
| height of disc space |  | 6 weeks after operation | 
| height of disc space |  | 3 months after operation | 
| height of disc space |  | 6 months after operation | 
| height of disc operation |  | 1st year after operation | 
| height of disc space |  | 3rd year after operation | 
| height of disc space |  | 5th year after operation |