Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01204008
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 75
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herniated Disc	Procedure: conservative discectomy; Procedure: aggressive discectomy	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy
• Study Start Date: Sep 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CS conservative discectomy	Procedure: conservative discectomy; a smaller incision with removal of the disc fragment with little invasion of the disc
Active Comparator: AS	Procedure: aggressive discectomy; a large open incision with aggressive removal of the disc fragments and curettage of the disc space

Outcome Measures

Primary Outcome Measures

1. patients satisfaction [6 weeks after intervention]

2. patients satisfaction [3 months after intervention]

3. patients satisfaction [6 months after intervention]

4. patients satisfaction [1st year after intervention]

5. patients satisfaction [3rd year after intervention]

6. patients satisfaction [5th year after intervention]

Secondary Outcome Measures

1. recurrence rate of disc herniation [6 weeks after operation]

2. recurrence rate of disc herniation [3 months after operation]

3. recurrence rate of disc herniation [6 months after operation]

4. recurrence rate of disc herniation [1st year after operation]

5. recurrence rate of disc herniation [3rd year after operation]

6. recurrence rate of disc herniation [5th year after operation]

7. height of disc space [6 weeks after operation]

8. height of disc space [3 months after operation]

9. height of disc space [6 months after operation]

10. height of disc operation [1st year after operation]

11. height of disc space [3rd year after operation]

12. height of disc space [5th year after operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen memorial hospital	Guangzhou	Guangdong	China	510120

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Principal Investigator: Dongsheng Huang, MD, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01204008
• Other Study ID Numbers: zseyhds2
• First Posted: Sep 17, 2010
• Last Update Posted: Sep 17, 2010
• Last Verified: Aug 1, 2007

• Additional relevant MeSH terms: Intervertebral Disc Displacement; Radiculopathy

Study Results

No Results Posted as of Sep 17, 2010