NCT00440856

Brief Summary

The trial aims to assess the hypothesis that presentation of the disc material to the patient following a lumbar microdiscectomy would positively influence the improvement in their leg and back symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 9, 2015

Status Verified

May 1, 2008

Enrollment Period

1.2 years

First QC Date

February 23, 2007

Last Update Submit

June 8, 2015

Conditions

Radiculopathy

Keywords

Intervertebral discLumbar discectomyOutcomeRadiculopathy due to prolapsed intervertebral disc.

Outcome Measures

Primary Outcomes (1)

  • Subjective experience of radiculopathic pain by the patient following surgery

    2-4 months

Secondary Outcomes (6)

  • Subjective experience of low back pain by the patient following surgery

    2-4 months

  • Subjective experience of lower limb motor weakness by the patient following surgery

    2-4 months

  • Subjective experience of paraesthesia by the patient following surgery

    2-4 months

  • Maximum walking distance

    2-4 months

  • Altered pattern of use of analgesia

    2-4 months

  • +1 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

experimental

EXPERIMENTAL

Participants are given their disc fragments following their operation

Behavioral: Presentation of excised intervertebral disc fragments

Interventions

Presentation of excised intervertebral disc fragmentsBEHAVIORAL
experimental

Eligibility Criteria

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

You may qualify if:

  • All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc

You may not qualify if:

  • inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's Hospital, University of London

London, London, SW17 0RE, United Kingdom

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Marios C Papadopoulos, DLitt

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 27, 2007

Study Start

February 1, 2007

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

June 9, 2015

Record last verified: 2008-05

Locations

GB(1)