Surgical Treatment of Adjacent Segment Stenosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 338
- Locations
- 1
Study Overview
Brief Summary
The goal of this clinical trial is to learn whether microdecompression alone is as effective as decompression with extension of fusion surgery in patients with symptomatic adjacent segment stenosis after previous lumbar fusion surgery.
The main questions it aims to answer are:
Is microdecompression alone non-inferior to decompression with extension of fusion in improving disability 24 months after surgery, as measured by the Oswestry Disability Index (ODI)? Does microdecompression alone result in similar or lower rates of complications, reoperations, pain, and radiological progression compared with decompression and fusion?
Researchers will compare microdecompression alone to decompression with extension of lumbar fusion to determine whether the less invasive procedure can achieve similar clinical outcomes while reducing surgical burden and preserving spinal structures.
Participants will:
Be randomly assigned to one of two treatment groups: microdecompression alone or decompression with extension of lumbar fusion.
Undergo the assigned surgical treatment. Attend clinical and radiological follow-up visits at 6, 12, and 24 months after surgery.
Complete questionnaires assessing disability, pain, quality of life, sleep quality, and mental health.
Undergo routine imaging and clinical examinations to evaluate treatment outcomes and possible complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years.
- •Oswestry Disability Index (ODI) between 30% and 80% at screening.
- •Symptomatic adjacent segment stenosis following degenerative lumbar fusion surgery.
- •Persistent symptoms despite at least 6 weeks of appropriate conservative treatment.
- •Radiological evidence of adjacent segment spinal stenosis on magnetic resonance imaging (MRI).
- •Ability to understand the study procedures and complete patient-reported outcome questionnaires.
- •Ability to provide written informed consent.
Exclusion Criteria
- •Adjacent segment kyphosis or scoliosis greater than 10 degrees.
- •Screw loosening or pseudarthrosis of the previous fusion construct.
- •Known current pregnancy or breastfeeding.
- •Acute traumatic spinal injury or fracture.
- •Active inflammatory disease of the spine.
- •Active neoplastic disease of the spine.
- •Contraindication to spinal surgery.
- •Inability to provide informed consent or complete study questionnaires.
- •Symptoms attributable to spinal stenosis are not the predominant clinical complaint
- •Foraminal stenosis grade ≥2 according to the Lee classification.
- •Dynamic spondylolisthesis ≥3 mm on flexion-extension radiographs.
- •Persons involuntarily detained by judicial or administrative order.
Investigators
Anton Früh
Principal Investigator
Charite University, Berlin, Germany