Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

Herniated Disc Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01204008
• Other study ID #: zseyhds2
• Status: Recruiting
• Phase: Phase 4
• First received: September 13, 2010
• Last updated: September 16, 2010
• Start date: September 2009
• Est. completion date: December 2015

Study information

• Verified date: August 2007
• Source: Sun Yat-sen University
• Contact: Dongsheng Huang, MD.
• Phone: 00862081332553
• Email: huangdongshen18[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herniated Disc
• Radiculopathy

Intervention

Procedure:
• conservative discectomy
a smaller incision with removal of the disc fragment with little invasion of the disc
• aggressive discectomy
a large open incision with aggressive removal of the disc fragments and curettage of the disc space

Locations

Country	Name	City	State
China	Sun Yat-Sen memorial hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients satisfaction		6 weeks after intervention	No
Primary	patients satisfaction		3 months after intervention	No
Primary	patients satisfaction		6 months after intervention	No
Primary	patients satisfaction		1st year after intervention	No
Primary	patients satisfaction		3rd year after intervention	No
Primary	patients satisfaction		5th year after intervention	No
Secondary	recurrence rate of disc herniation		6 weeks after operation	No
Secondary	recurrence rate of disc herniation		3 months after operation	No
Secondary	recurrence rate of disc herniation		6 months after operation	No
Secondary	recurrence rate of disc herniation		1st year after operation	No
Secondary	recurrence rate of disc herniation		3rd year after operation	No
Secondary	recurrence rate of disc herniation		5th year after operation	No
Secondary	height of disc space		6 weeks after operation	No
Secondary	height of disc space		3 months after operation	No
Secondary	height of disc space		6 months after operation	No
Secondary	height of disc operation		1st year after operation	No
Secondary	height of disc space		3rd year after operation	No
Secondary	height of disc space		5th year after operation	No