NCT01204008

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 17, 2010

Status Verified

August 1, 2007

Enrollment Period

3.3 years

First QC Date

September 13, 2010

Last Update Submit

September 16, 2010

Conditions

Herniated Disc

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

CS

EXPERIMENTAL

conservative discectomy

Procedure: conservative discectomy

AS

ACTIVE COMPARATOR
Procedure: aggressive discectomy

Interventions

conservative discectomyPROCEDURE

a smaller incision with removal of the disc fragment with little invasion of the disc

CS
aggressive discectomyPROCEDURE

a large open incision with aggressive removal of the disc fragments and curettage of the disc space

AS

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen memorial hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dongsheng Huang, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongsheng Huang, MD.

CONTACT

00862081332553huangdongshen18@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 17, 2010

Study Start

September 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2015

Last Updated

September 17, 2010

Record last verified: 2007-08

Locations

CN(1)