Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

Phase 4

• Conditions: Herniated Disc

• Registration Number: NCT01204008
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2007-08
• Study Start: 2009-09
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-16
• Last Update Submitted: 2010-09-16
• Study First Posted: 2010-09-17
• Last Update Posted: 2010-09-17
• Primary Completion: 2012-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
patients satisfaction	5th year after intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sun Yat-Sen memorial hospital; 🇨🇳 Guangzhou, Guangdong, China