NCT07661199 Surgical Treatment of Adjacent Segment Stenosis
| NCT ID | NCT07661199 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Adjacent Segment Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 338 participants |
| Start Date | 2026-10-27 |
| Primary Completion | 2030-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 338 participants in total. It began in 2026-10-27 with a primary completion date of 2030-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07661199 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adjacent Segment Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07661199 currently recruiting?
Yes, NCT07661199 is actively recruiting participants. Contact the research team at anton.frueh@charite.de for enrollment information.
Where is the NCT07661199 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07661199 clinical trial?
NCT07661199 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 338 participants.