Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
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 lumbar degenerative disease are prospectively enrolled and followed. Important adjacent pre-existing degeneration factors include discs degenerated, facets and ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). This study will focus on the effects of pre- existing adjacent degeneration (disc factors and spinal canal stenosis factors) on long-term postoperative outcomes.
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);
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 population
In the orthopaedic department of Peking University Third Hospital, patients with a clear diagnosis of lumbar degenerative disease, and surgical level of L4-S1 will be enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pre-existing degenerative factors at adjacent segment
Other interventionPre-existing degenerative factors at adjacent segment, including disc factors and canal stenosis factors
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: NS Group0 interventions
Group B: D Group1 intervention
Group C: C Group1 intervention
Trial outcomes
Primary outcomes
1
Adjacent segment degeneration (ASDeg)
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)
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)
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)
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