NCT01499641

Brief Summary

Focus of this study is evaluation of the outcome, neurologic impairment and safety of epidural steroide following lumbar discectomy for herniated disc disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

May 1, 2001

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

2.3 years

First QC Date

December 13, 2011

Last Update Submit

September 12, 2014

Conditions

Disc Disease

Keywords

discectomymethylprednisolonerandomized control trial

Outcome Measures

Primary Outcomes (1)

  • Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up.

    2 years

Secondary Outcomes (1)

  • Hospital stay, back and leg pain and reflex deficit.

    2 years

Study Arms (2)

Epidural steroid

ACTIVE COMPARATOR

1.0 mL methylprednisolone acetate 40 mg/mL instilled at the decompressed nerve root

Drug: Methylprednisolone

None epidural steroid

EXPERIMENTAL
Drug: Methylprednisolone

Interventions

MethylprednisoloneDRUG

Epidural methylprednisolone 40 mg or none

Epidural steroidNone epidural steroid

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary lumbar herniated disc disease who had received and performed standardized conservative treatment program with intensive exercises
  • Patients more than 18 years old

You may not qualify if:

  • Patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion
  • Patients with cauda equina syndrome who needed acute operative treatment
  • Lack of informed consent and inability to read and understand Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Orthopaedic Surgery Research Unit, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet

Copenhagen, Denmark

Location

Department of Orthopaedic Surgery, Vejle and Give Hospital

Vejle, Denmark

Location

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Sten Rasmussen, M.D.Sci.

    Orthopaedic Research Unit, Aalborg University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 26, 2011

Study Start

May 1, 2001

Primary Completion

August 1, 2003

Study Completion

December 1, 2005

Last Updated

September 15, 2014

Record last verified: 2014-09

Locations

DK(3)