The Sciatica-Gill trial is a randomised cost-effective study about nerve root decompression according to Gill versus instrumented fusion in the treatment of patients with radicular legpain or neurogenic claudication due to spondylolytic…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Spinal cord and nerve root disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is an illness-specific 23 item functional
assessment questionnaire; the Roland Disability Questionnaire for Sciatica.
Secondary outcome
Secundary 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.
Background summary
Spondylolytic spondylolisthesis is an anterior slip of one verebral body onto
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). Up to now, no randomised trial has been conducted comparing
instrumented fusion with nerve root decompression in the treatment of radicular
pain caused by spondylolytic spondylolisthesis.
Study objective
The Sciatica-Gill trial is a randomised cost-effective study about nerve root
decompression according to Gill versus instrumented fusion in the treatment of
patients with radicular legpain or neurogenic claudication due to spondylolytic
spondylolisthesis.
Study design
The trial is a prospective randomised multicenter trial with parallel group
design and 5 years follow-up.
Intervention
Nerve root decompression according to Gill versus instrumented spondylodesis.
Study burden and risks
Patient's history and standard neurological examination will be documented in
the out-patient clinic, and various questionnaires will be sent by mail.
Patients treated with nerve root decompression according to Gill may have risk
of recurrent or persistent symptoms so that secondary spondylodesis may be
necessary. Hypothetically, there is a risk of progressive slip or persistent
backpain when no instrumented fusion is performed.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Age 18-70 years. Low grade spondylolytic spondylolisthesis (grade I or II). Sciatica or neurogenic claudication with/without backpain. Symptoms lasting more than 3 months. Informed consent.
Exclusion criteria
High grade spondylolytic spondylolisthesis (grade III or IV). Backpain only. Progressive spondylolisthesis. Abnormal mobility on dynamic X-ray (> 3 mm). Previous lumbar surgery at level of spondylolisthesis. Severe comorbidity / contraindication surgery. Planned (e)migration in the year after surgery. Inadequate knowledge of Dutch language. Pregnancy.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21325.058.07 |