Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital
About this trial
This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for degenerative disease are prospectively enrolled and followed. Patients enrolled in this study have asymptomatic pre-existing spinal canal stenosis at adjacent segment. This study will focus on the effects of preventative limited decompression at adjacent segment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A clear diagnosis of lumbar spinal stenosis, and surgical level of L4-S1 (The levels to be operated on were decided by matching the clinical symptomatology with the radiological findings of the spinal levels that needed decompression);
Patients have asymptomatic pre-existing spinal canal stenosis (cerebrospinal fluid occlusion grade=1) at adjacent segment.
Failed at least eight weeks conservative treatment;
Disqualifiers
Unstable factors (slip, rotation, lateral bending, etc.) in adjacent segment L3/4;
Preoperative sagittal and coronal imbalance of the spine;
Lumbar infection and/or tumor diseases;
A previous history of lumbar fusion surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosis
Procedure/SurgeryIn terms of limited decompression at the adjacent segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle will be performed. Complete laminectomy and destroy of posterior ligament complex will be avoided.
Responsible segments fused
Procedure/SurgeryIn terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: NS GroupActive comparator 1 intervention
Group B: LD GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Adjacent segment degeneration
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Time frame
12 months after surgery2
Adjacent segment degeneration
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Time frame
24 months after surgery3
Adjacent segment degeneration
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Time frame
60 months after surgery4
Adjacent segment degeneration
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
Time frame
120 months after surgerySecondary outcomes
1
Disability
The Oswestry Disability Index (ODI) (0-100) is used to assess disability.
Time frame
12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.2
Back pain
The Visual Analog Scale (0-10) is used to evaluate back pain.
Time frame
12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.3
Leg pain
The Visual Analog Scale (0-10) is used to evaluate leg pain.
Time frame
12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.Sponsors and contacts
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Source ClinicalTrials.gov