NL-OMON50599
Recruiting
Not Applicable
Minimally Invasive Surgery versus Open Surgery (MISOS) in the treatment of spondylolisthesis; a randomised controlled trial. - MISOS trial
neurochirurgie0 sites184 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- spondylolisthesis
- Sponsor
- neurochirurgie
- Enrollment
- 184
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •\* 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.
Outcomes
Primary Outcomes
Not specified
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