A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Herniated Disc
- Sponsor
- Sun Yat-sen University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- patients satisfaction
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
patients satisfaction
Time Frame: 5th year after intervention
Secondary Outcomes
- recurrence rate of disc herniation(5th year after operation)
- height of disc space(5th year after operation)
- height of disc operation(1st year after operation)