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Surgical Treatment of Adjacent Segment Stenosis
Sponsor: Charite University, Berlin, Germany
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
338
Start Date
2026-10-01
Completion Date
2031-03-01
Last Updated
2026-06-22
Healthy Volunteers
No
Interventions
Microsurgical Decompression with Extension of Fusion
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
Microsurgical Decompression Alone
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.
Locations (1)
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany