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The Sciatica - Gill Trial


- candidate number3243
- NTR NumberNTR1300
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2008
- Secondary IDsP08.010 METC LUMC
- Public TitleThe Sciatica - Gill Trial
- Scientific TitleCost effectiveness of nerve root decompression according to Gill versus instrumented fusion in the treatment of spondylolytic spondylolisthesis; a multicenter prospective randomised trial.
- ACRONYMN/A
- hypothesisThe trial concentrate on the question is a instrumented fusion in the treatment of spondylolytic spondylisthesis (cost) effectiveness than a decomporession according to Gill, both in short and long term.
- Healt Condition(s) or Problem(s) studiedSpondylolisthesis, Sciatica, Spondylolytic spondylolisthesis, Decompression
- Inclusion criteria1. Age 18-70 years
2. Low grade spondylolytic spondylolisthesis (grade I or II)
3. Sciatica or neurogenic claudication with or without backpain
4. Symptoms lasting more than 3 months.
5. Inform consent
- Exclusion criteria1.High grade spondylolytic spondylolisthesis (grade III or IV)
2. Backpain only
3. Progressive spondylolisthesis
4. Abnormal mobility X-ray (> 3mm)
5. Previous lumbar surgery at level of spondylolusthesis
6. Severe comorbidity / contra-indication surgery
7. Planned (e)migration in the year after surgery
8. Inadequate knowledge of Dutch language
9. Pregnancy
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2008
- planned closingdate1-mei-2015
- Target number of participants220
- InterventionsPatients present with radicular pain or neurogenic claudication with or without backpain caused by nerve root compression underneath the newly formed pseudojoint, or compression in the foramen between pedicle and slip disc. Surgical treatment consists of excision of the pseudojoint:

Group A: Nerveroot decompression according to Gill

Group B: Nerveroot decompression acoording to Gill in combination with instrumented fusion.

- Primary outcomeThe primary outcome measure is an illness-specific 23 item functional assessment questionnaire; the Roland Disability Questionnaire for Sciatica.
- Secondary outcomeSecundary outcome measures are:
Horizontal 100mm Visual Analoge Scale (VAS) for legpain and backpain, perceived recovery on the 7-point Likert scale adjusted to job and hobby, functional outcome of the patient by the surgeon using the Macnab classification, work experience according to the Karasek Job Content Questionnaire, emotional status of the patient determined by the Hospital Anxiety Depression Scale (HADS), quality of life according to a generic health status questionnaire SF-36, Quality-Adjusted-Lifeyears (QALY) based on EuroQol, serum level creatine phosphokinase (CPK) , dynamic X-ray of the lumbar spine, complications and re-operation incidence.
The economic evaluation will compare differences in societal costs to differences in the primary outcome measure (NDI) and in quality adjusted life years (QALYs). In the primary analysis QALYs will be calculated from the EQ-5D, in secondary analyses also from the SF-6D and VAS. Sensitivity analyses will be performed on the intervention costs, societal versus health care perspective, and the applied utility measure (EQ-5D, SF-6D or VAS). A time-horizon of 5 years will be used, with discounting for both costs and QALYs.
- TimepointsFollow up of all patients will be performed at 6, 12, 26, 52, 104 and 260 after surgery.
Questions will be send by mail.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES SIPS-group Leiden-The Hague
- CONTACT for SCIENTIFIC QUERIES M.P. Arts
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summarySpondylolytic spondylolisthesis is an anterior slip of one verebral body on to another caused by a disconnection of the pars interarticularis of the arch. Patients present with radicular pain or neurogenic claudication with or without backpain caused by nerve root compression underneath the newly formed pseudojoint, or compression in the foramen between pedicle and slipped disc. Surgical treatment consists of excision of the pseudojoint (nerveroot decompression according to Gill) mostly in combination with instrumented fusion. Instrumented spondylodesis is major surgery with a substantial complication rate and it's necessity has not been proven. Nerve root decompression according to Gill is a less invasive procedure with short hospitalisation, quick mobilisation and fast resumption of daily activities. Therefore, we postulate that Gill's procedure is more cost-effective on the short term (12 weeks) and at least equal cost-effective on the long term (2 years).
- Main changes (audit trail)
- RECORD28-apr-2008 - 15-feb-2015


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