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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Microsurgical Decompression with Extension of Fusion
Procedure/SurgeryParticipants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
Microsurgical Decompression Alone
Procedure/SurgeryParticipants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.
Treatment groups
338 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
24 months after surgerySecondary outcomes
1
Pain related disability
Disability related to low back pain assessed using the Oswestry Disability Index (ODI). The ODI score ranges from 0 to 100%, with higher scores indicating greater disability and worse functional impairment.
Time frame
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.2
Leg Pain Intensity at Rest
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for leg pain at rest.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.3
Leg Pain Intensity during Movement
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for leg pain during movement.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.4
Back Pain Intensity at Rest
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for back pain at rest.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: