Surgical Treatment of Adjacent Segment Stenosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Microsurgical Decompression with Extension of Fusion
  • Microsurgical Decompression Alone

Treatment groups

338 Participants
are divided into 2 treatment groups