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ID
Source
Brief title
Health condition
spondylolytic spondylolisthesis; decompression; spondylodesis; sciatica.
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 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).
Study objective
The 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.
Study design
Follow up of all patients will be performed at 6, 12, 26, 52, 104 and 260 after surgery.
Questions will be send by mail.
Intervention
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 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.
SIPS-group Leiden-The Hague
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262144
sips@lumc.nl
SIPS-group Leiden-The Hague
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262144
sips@lumc.nl
Inclusion criteria
1. 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 criteria
1.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
Design
Recruitment
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 |
|---|---|
| NTR-new | NL1254 |
| NTR-old | NTR1300 |
| Other | METC LUMC : P08.010 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |