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Surgical Treatment of Adjacent Segment Stenosis

NCT07661199 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2026-06-22

No results posted yet for this study

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.

Conditions

  • Adjacent Segment Disease
  • Lumbar Spinal Stenosis

Interventions

PROCEDURE

Microsurgical Decompression with Extension of Fusion

Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.

PROCEDURE

Microsurgical Decompression Alone

Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2030-09-30
Completion
2031-03-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07661199 on ClinicalTrials.gov