Epidural Steroid Following Discectomy for Herniated Disc... | NCT01499641

Studies
Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

NCT01499641

Sponsor

Northern Orthopaedic Division, Denmark

Status

Completed

Last Update Posted

Sep 15, 2014Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Disc Disease

Interventions

Methylprednisolone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2001

Primary Completion Date

Aug 2003Actual

Completion Date

Dec 2005Actual

First Submitted Date

Dec 13, 2011

First Submission Date that Met QC Criteria

Dec 22, 2011

First Posted Date

Dec 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2014

Last Update Posted Date

Sep 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Methylprednisolone might enhance recovery after discectomy for herniated disc disease without apparent side effect.

Convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response. In arthroscopic and abdominal surgery steroids reduce the inflammatory response and enhance recovery.

200 patients with herniated disc disease are randomly allocated to receive epidural methylprednisolone 40 mg or none.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Methylprednisolone	Drug	Epidural methylprednisolone 40 mg or none	Epidural steroid None epidural steroid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up.		2 years

Secondary Outcomes

Measure	Description	Time Frame
Hospital stay, back and leg pain and reflex deficit.		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

66 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sten Rasmussen, M.D.Sci.	Orthopaedic Research Unit, Aalborg University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopaedic Surgery Research Unit, Aalborg University Hospital		Aalborg		9000	Denmark
Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet

Intervention Browse Module

MeSH Terms

ID	Term
D008775	Methylprednisolone

Ancestor Terms

ID	Term
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes

Browse Leaves

Not provided

Browse Branches

Not provided