Minimally Invasive Surgery versus Open Surgery (MISOS) in the treatment of spondylolisthesis; a randomised controlled trial.

Recruiting

• Conditions: spondylolisthesis; vertebral slippage; 10005959; 10041543; 10009720

• Registration Number: NL-OMON50599
• Lead Sponsor: neurochirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 184

Inclusion Criteria

* Age between 18 and 75 years.
* Neurogenic claudication or radicular leg pain with or without low back pain.
* Degenerative or spondylolytic spondylolisthesis grade I or II with spinal
stenosis.
* Persistent complaints for at least 3 months, regardless conservative
treatments.
* Be able to understand the Dutch language and comprehend the questionnaires
and patient information.
* Written informed consent given.

Exclusion Criteria

* Previous spine fusion surgery at the same level.
* More than 1 symptomatic level that need fusion.
* Osteoporosis.
* Active infection or prior infection at the surgical site.
* Active cancer.
* Contraindication for surgery.
* Severe mental or psychiatric disorder.
* Alcoholism.
* Morbid obesity (BMI > 40).
* Pregnancy.
* Inadequate knowledge of Dutch language.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Score on the Visual Analoge Scale (VAS) for low back pain (ranging from 0 - 100<br /><br>mm) at 2 and 6 weeks after surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire for<br /><br>Sciatica (RMDQ), self perceived recovery according to the patient (Likert), VAS<br /><br>leg pain, quality of life (EQ-5D), re-surgery, complications, and fusion<br /><br>(evaluated on CT).</p><br>