NCT07661199|RecruitingDMC
Surgical Treatment of Adjacent Segment Stenosis
STASS
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STASS
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Deutsche Forschungsgemeinschaft (DFG)
interventional
338
1 country
1
Study Start
October 27, 2026
Actual (reported)Primary Completion
September 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 29, 2026
Actual (reported)June 22, 2026
Actual (reported)October 27, 2026
Actual (reported)September 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Proportion of Participants Achieving at Least 30% Reduction in Oswestry Disability Index (ODI)
The primary endpoint is the proportion of participants achieving a reduction of at least 30% in the Oswestry Disability Index (ODI) compared with baseline. The ODI is a validated patient-reported outcome measure assessing disability related to lumbar spine disorders on a scale from 0% to 100%. A reduction of at least 30% is considered clinically meaningful.
24 months after surgery
Pain related disability
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Leg Pain Intensity at Rest
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Leg Pain Intensity during Movement
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Back Pain Intensity at Rest
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Back Pain Intensity during Movement
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Decompression and fusion
Mircosurgical decompression only
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117, Germany
First Submitted
May 29, 2026
First Posted
June 22, 2026
Study Start
October 27, 2026
Actual (reported)Primary Completion
September 30, 2030
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
Individual participant data underlying the results reported in publications arising from this study, after de-identification, will be made available upon reasonable request to the corresponding investigator. Supporting documents including the study protocol, statistical analysis plan, and data dictionary will also be made available.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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