Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2007-02-28
2008-05-31
Brief Summary
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Detailed Description
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Design. Data will be collected prospectively. Patient allocation to treatment groups will be by simple randomization using a computer generated sequence of random numbers. Trial participants will be blinded as to the trial hypothesis and investigators blinded to patient allocation.
Setting. Patients will all be treated in a single secondary care unit.
Participants. All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc over a six month period will be considered for entry into the trial. Exclusion criteria: inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.
Intervention. Patients allocated to the experimental arm will be given the removed disc fragments to keep once they have recovered from anaesthesia. Those in the control arm will not be shown disc fragments (best available treatment).
Main outcome measure. The degree of improvement in radiculopathic and degenerative symptoms reported by the patient at 2-3 months after surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Control
No interventions assigned to this group
experimental
Participants are given their disc fragments following their operation
Presentation of excised intervertebral disc fragments
Interventions
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Presentation of excised intervertebral disc fragments
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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St George's, University of London
OTHER
Responsible Party
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Principal Investigators
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Marios C Papadopoulos, DLitt
Role: PRINCIPAL_INVESTIGATOR
St George's, University of London
Locations
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St George's Hospital, University of London
London, London, United Kingdom
Countries
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Other Identifiers
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DT2656
Identifier Type: -
Identifier Source: org_study_id
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