Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion

Condition(s) studied

Investigational drug(s) / intervention(s)

Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosis: 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.

Responsible segments fused: In terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).

Study summary

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

Primary outcome measure(s)

• Adjacent segment degeneration — 12 months after surgery
  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.
• Adjacent segment degeneration — 24 months after surgery
  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.
• Adjacent segment degeneration — 60 months after surgery
  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.
• Adjacent segment degeneration — 120 months after surgery
  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.
• Adjacent segment disease — The entire study process, up to 120 months after surgery.
  ASDis is defined as clinical and radiographic evidence of degenerative spinal disease (disc degeneration, stenosis, or spondylolisthesis) on the level adjacent to the index fusion.

Trial sites (1)

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