The Sciatica - Gill Trial

Cost effectiveness of nerve root decompression according to Gill versus instrumented fusion in the treatment of spondylolytic spondylolisthesis; a multicenter prospective randomised trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27610

Enrollment

220

Registered

2008-04-28

Start date

2008-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spondylolytic spondylolisthesis

Interventions

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

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The primary outcome measure is an illness-specific 23 item functional assessment questionnaire; the Roland Disability Questionnaire for Sciatica.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactSIPS-group Leiden-The Hague

LUMC, afdeling neurochirurgie

sips@lumc.nl+31 (0)71 5262144

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)