Microdecompression alone vs. decompression with fusion in adjacent segment stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two surgical approaches for symptomatic adjacent segment stenosis after lumbar fusion: microdecompression alone and decompression with extension of fusion. Participants are adults with ODI 30-80% and MRI-confirmed adjacent segment stenosis who have failed at least 6 weeks of conservative care. They are randomly assigned to one of the two procedures and followed for 24 months to assess disability (ODI), complications, reoperations, pain, and radiological progression. The trial is led by Charité – Universitätsmedizin Berlin, evaluating whether the simpler procedure can provide similar outcomes with potentially fewer risks and less surgical burden.

Why it matters

Who can join: the full rules

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.

Where it's running

• Charité - Universitätsmedizin Berlin
  Berlin, State of Berlin, Germany Recruiting

Study contacts

• Study coordinator: Anton Früh, PD MD M.Sc.
• Email: anton.frueh@charite.de
• Phone: +49 030 450 660 376

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Spine Surgery

  This study tests whether the height of the irrigation fluid bag and the direction of the surgical cut affect fluid pressure, visibility, and early recovery in adults undergoing unilateral biportal endoscopic spine surgery.

  Recruiting First Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07837427

• Comparison of two TLIF procedures for single-level lumbar spinal stenosis

  This trial tests two minimally invasive TLIF procedures (LUSE-TLIF and MIS-TLIF) to see which better helps people with single-level lumbar spinal stenosis who have not improved with non-surgical treatments.

  Recruiting The Third Affiliated Hospital of Southern Medical University · Guangzhou, Guangdong · NCT07588555

• Opioid-free versus opioid-based anesthesia for elective lumbar spine surgery

  This test compares opioid-free multimodal anesthesia (with or without an erector spinae plane block) against opioid-containing anesthesia in adults having elective lumbar spine surgery to see which controls pain better and reduces opioid need in the first 48 hours after surgery.

  Recruiting Marmara University · Istanbul, Maltepe · NCT07489001

• Prevalence of PAD in Patients With Surgically Treated Lumbar Spinal Stenosis

  This study tests how common peripheral artery disease is in people who have lumbar spinal stenosis and are being considered for, or have had, surgery.

  Recruiting Rennes University Hospital · Lille and 2 other locations · NCT07469020

• Decompressive laminectomy alone versus laminectomy with transpedicular screw fixation for lumbar spinal stenosis

  Adults age 30–60 with multilevel lumbar spinal stenosis who haven't improved after six weeks of non-surgical care will be randomly assigned to decompressive laminectomy alone or to laminectomy plus transpedicular screw fixation to see which option relieves pain, improves function, and gives better spinal stability.

  Recruiting Early Phase 1 Punjab Health Care Commission · Lahore, Punjab Province · NCT07281625

• Dural pulsation in people with lumbar spinal stenosis

  This study will see if the presence of dural pulsation on MRI is linked to symptoms and imaging findings in people with lumbar spinal stenosis.

  Recruiting Marmara University · Pendik, Istanbul · NCT07233798

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.