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.
ID
Bron
Verkorte titel
Aandoening
spondylolytic spondylolisthesis; decompression; spondylodesis; sciatica.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure is an illness-specific 23 item functional assessment questionnaire; the Roland Disability Questionnaire for Sciatica.
Achtergrond van het onderzoek
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).
Doel van het onderzoek
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.
Onderzoeksopzet
Follow up of all patients will be performed at 6, 12, 26, 52, 104 and 260 after surgery.
Questions will be send by mail.
Onderzoeksproduct en/of interventie
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.
Publiek
SIPS-group Leiden-The Hague
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262144
sips@lumc.nl
Wetenschappelijk
SIPS-group Leiden-The Hague
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262144
sips@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL1254 |
NTR-old | NTR1300 |
Ander register | METC LUMC : P08.010 |
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