Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2007 by Sun Yat-sen University
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01204008
First received: September 13, 2010
Last updated: September 16, 2010
Last verified: August 2007
  Purpose

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 Intervention Phase
Herniated Disc
Procedure: conservative discectomy
Procedure: aggressive discectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • patients satisfaction [ Time Frame: 6 weeks after intervention ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: 1st year after intervention ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: 3rd year after intervention ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: 5th year after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • recurrence rate of disc herniation [ Time Frame: 6 weeks after operation ] [ Designated as safety issue: No ]
  • recurrence rate of disc herniation [ Time Frame: 3 months after operation ] [ Designated as safety issue: No ]
  • recurrence rate of disc herniation [ Time Frame: 6 months after operation ] [ Designated as safety issue: No ]
  • recurrence rate of disc herniation [ Time Frame: 1st year after operation ] [ Designated as safety issue: No ]
  • recurrence rate of disc herniation [ Time Frame: 3rd year after operation ] [ Designated as safety issue: No ]
  • recurrence rate of disc herniation [ Time Frame: 5th year after operation ] [ Designated as safety issue: No ]
  • height of disc space [ Time Frame: 6 weeks after operation ] [ Designated as safety issue: No ]
  • height of disc space [ Time Frame: 3 months after operation ] [ Designated as safety issue: No ]
  • height of disc space [ Time Frame: 6 months after operation ] [ Designated as safety issue: No ]
  • height of disc operation [ Time Frame: 1st year after operation ] [ Designated as safety issue: No ]
  • height of disc space [ Time Frame: 3rd year after operation ] [ Designated as safety issue: No ]
  • height of disc space [ Time Frame: 5th year after operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204008

Contacts
Contact: Dongsheng Huang, MD. 00862081332553 huangdongshen18@hotmail.com

Locations
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         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Dongsheng Huang, MD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Dongsheng Huang, MD., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01204008     History of Changes
Other Study ID Numbers: zseyhds2
Study First Received: September 13, 2010
Last Updated: September 16, 2010
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Radiculopathy
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on October 21, 2014