Clinical trial NCT01204008: Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy
Official title: A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Herniated Disc
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: patients satisfaction
timeFrame: 6 weeks after intervention
measure: patients satisfaction
timeFrame: 3 months after intervention
measure: patients satisfaction
timeFrame: 6 months after intervention
measure: patients satisfaction
timeFrame: 1st year after intervention
measure: patients satisfaction
timeFrame: 3rd year after intervention
measure: patients satisfaction
timeFrame: 5th year after intervention
Secondary outcomes:
measure: recurrence rate of disc herniation
timeFrame: 6 weeks after operation
measure: recurrence rate of disc herniation
timeFrame: 3 months after operation
measure: recurrence rate of disc herniation
timeFrame: 6 months after operation
measure: recurrence rate of disc herniation
timeFrame: 1st year after operation
measure: recurrence rate of disc herniation
timeFrame: 3rd year after operation
measure: recurrence rate of disc herniation
timeFrame: 5th year after operation
measure: height of disc space
timeFrame: 6 weeks after operation
measure: height of disc space
timeFrame: 3 months after operation
measure: height of disc space
timeFrame: 6 months after operation
measure: height of disc operation
timeFrame: 1st year after operation
measure: height of disc space
timeFrame: 3rd year after operation
measure: height of disc space
timeFrame: 5th year after operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen memorial hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Dongsheng Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: