Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01204008 |
Recruitment Status : Unknown
Verified August 2007 by Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : September 17, 2010
Last Update Posted : September 17, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 Type : | Interventional (Clinical Trial) |
Estimated 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 : | September 2009 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | December 2015 |
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 |
- patients satisfaction [ Time Frame: 6 weeks after intervention ]
- patients satisfaction [ Time Frame: 3 months after intervention ]
- patients satisfaction [ Time Frame: 6 months after intervention ]
- patients satisfaction [ Time Frame: 1st year after intervention ]
- patients satisfaction [ Time Frame: 3rd year after intervention ]
- patients satisfaction [ Time Frame: 5th year after intervention ]
- recurrence rate of disc herniation [ Time Frame: 6 weeks after operation ]
- recurrence rate of disc herniation [ Time Frame: 3 months after operation ]
- recurrence rate of disc herniation [ Time Frame: 6 months after operation ]
- recurrence rate of disc herniation [ Time Frame: 1st year after operation ]
- recurrence rate of disc herniation [ Time Frame: 3rd year after operation ]
- recurrence rate of disc herniation [ Time Frame: 5th year after operation ]
- height of disc space [ Time Frame: 6 weeks after operation ]
- height of disc space [ Time Frame: 3 months after operation ]
- height of disc space [ Time Frame: 6 months after operation ]
- height of disc operation [ Time Frame: 1st year after operation ]
- height of disc space [ Time Frame: 3rd year after operation ]
- height of disc space [ Time Frame: 5th year after operation ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204008
Contact: Dongsheng Huang, MD. | 00862081332553 | huangdongshen18@hotmail.com |
China, Guangdong | |
Sun Yat-Sen memorial hospital | Recruiting |
Guangzhou, Guangdong, China, 510120 | |
Contact: Dongsheng Huang, MD 00862081332553 huangdongshen18@hotmail.com | |
Principal Investigator: Dongsheng Huang, MD |
Principal Investigator: | Dongsheng Huang, MD | Sun Yat-sen University |
Responsible Party: | Dongsheng Huang, MD., Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT01204008 |
Other Study ID Numbers: |
zseyhds2 |
First Posted: | September 17, 2010 Key Record Dates |
Last Update Posted: | September 17, 2010 |
Last Verified: | August 2007 |
Intervertebral Disc Displacement Radiculopathy Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
Hernia Pathological Conditions, Anatomical Spinal Diseases Bone Diseases Musculoskeletal Diseases |