Degenerative Disc Disease Clinical Trial
Official title:
Preventive Effect of Limited Decompression on Adjacent Segment With Pre-existing Spinal Canal Stenosis Following Posterior Lumbar Interbody Fusion: a Prospective Interventional Study
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.
Adjacent segment pathologies (ASP), including radiological adjacent segment degeneration
(ASDeg) and adjacent segment disease (ASDis) after lumbar fusion surgeries have been
troubling complications. The development of ASDis greatly reduces postoperative quality of
life, and revision surgery may be required in severe cases. Several risk factors for ASP have
been reported, such as age, sex, pre-existing adjacent degeneration, multilevel fusions,
sagittal imbalance, the type of fusion, facet tropism and laminar inclination. Previous
studies have reported asymptomatic pre-existing spinal canal stenosis (SCS) as a risk factor
for ASDis that requires additional surgery. Appropriate strategy needs to be explored for the
treatment of asymptomatic pre-existing spinal canal stenosis.
Limited decompressions, including partial laminotomy and flavectomy, have been proved to have
the role of enlargement in spinal canal. Therefore, we hypothesize that limited
decompressions at adjacent segment with asymptomatic pre-existing SCS will have the
preventive effect on ASP.
This prospective study will be limited to patients with the same preoperative pathology, the
same fusion segments (L4-5 and L5-S1), the same fusion technique (PLIF). Dynamic X-ray and
MRI examinations of lumbar will be completed to evaluate the imaging manifestations of the
responsible and adjacent segments before surgery. Patients with asymptomatic pre-existing
canal stenosis factors (cerebrospinal fluid occlusion grade 1) at L3/4 segment will be
enrolled. Patients will be randomly divided into two groups according to different
strategies. NS Group includes patients who simply receive responsible segments fused (L4-S1).
LD Group includes patients who receive responsible segments fused (L4-S1) plus limited
decompression at adjacent segment (L3/4). In 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.
The patient's age, gender, preoperative body mass index (BMI), American Society of
Anesthesiologists classification of anesthesia (ASA grade) will be recorded during the
hospital stay. Surgical data including operation time, blood loss, perioperative
complications (including cerebrospinal fluid leakage, wound infection, postoperative
neurological dysfunction, and perioperative secondary surgery, cardiopulmonary complication,
cerebral infarction/hemorrhage, etc.), and length of hospital stay are also recorded.
Preoperative clinical function questionnaires, including visual analog scale (VAS) of low
back, VAS of the legs, and Oswestry Disability Index (ODI) scores for patients were completed
on admission for surgery without any assistance. All the patients enrolled will finished the
follow-up from date of surgery at 1,2, 5 and 10 years. The clinical outcomes and ASP will be
recorded.
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