Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

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

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.

Study Overview

• Status: Unknown
• Conditions: Herniated Disc
• Intervention / Treatment: Procedure: conservative discectomy; Procedure: aggressive discectomy

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-sen Memorial Hospital
      • Contact: Dongsheng Huang, MD; Phone Number: 00862081332553; Email: huangdongshen18@hotmail.com
      • Principal Investigator: Dongsheng Huang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
patients satisfaction	6 weeks after intervention
patients satisfaction	3 months after intervention
patients satisfaction	6 months after intervention
patients satisfaction	1st year after intervention
patients satisfaction	3rd year after intervention
patients satisfaction	5th year after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
recurrence rate of disc herniation	6 weeks after operation
recurrence rate of disc herniation	3 months after operation
recurrence rate of disc herniation	6 months after operation
recurrence rate of disc herniation	1st year after operation
recurrence rate of disc herniation	3rd year after operation
recurrence rate of disc herniation	5th year after operation
height of disc space	6 weeks after operation
height of disc space	3 months after operation
height of disc space	6 months after operation
height of disc operation	1st year after operation
height of disc space	3rd year after operation
height of disc space	5th year after operation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 13, 2010
• First Submitted That Met QC Criteria: September 16, 2010
• First Posted (Estimate): September 17, 2010

Study Record Updates

• Last Update Posted (Estimate): September 17, 2010
• Last Update Submitted That Met QC Criteria: September 16, 2010
• Last Verified: August 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Radiculopathy
• Other Study ID Numbers: zseyhds2