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Randomized Controlled Trial
. 2022 Feb 23:17:175-184.
doi: 10.2147/CIA.S349533. eCollection 2022.

Cortical Trajectory Fixation Versus Traditional Pedicle-Screw Fixation in the Treatment of Lumbar Degenerative Patients with Osteoporosis: A Prospective Randomized Controlled Trial

Hongtao Ding  1 , Yong Hai  1 , Yuzeng Liu  1 , Li Guan  1 , Aixing Pan  1 , Xinuo Zhang  1 , Bo Han  1 , Yue Li  1 , Peng Yin  1
Affiliations
Randomized Controlled Trial

Cortical Trajectory Fixation Versus Traditional Pedicle-Screw Fixation in the Treatment of Lumbar Degenerative Patients with Osteoporosis: A Prospective Randomized Controlled Trial

Hongtao Ding et al. Clin Interv Aging. .

Abstract

Study design: This was a prospective randomized controlled trial study.

Objective: To elucidate clinical and radiographic outcomes and complications of cortical bone trajectory (CBT)-screw fixation in patients with osteoporosis at 24-month follow-up and to compare the results with those after transforaminal lumbar interbody fusion (TLIF) using traditional pedicle screw (PS) fixation.

Methods: We enrolled 124 patients and randomly assigned them to two groups (each group had 62 participants). The primary outcome was fusion rate. Secondary outcomes were VAS, Oswestry Disability Index (ODI), and Japanese Orthopaedic Association (JOA) scores, operation duration, incision length, estimated blood loss, drainage volume, radiological outcomes, and complications.

Results: At the 6- and 12-month follow-up points, similar fusion rates were observed based on CT scans in both groups (P=0.583 and 0.583). CBT provided significantly better short-term functional status at 3 months postoperation on ODI and JOA scores (P=0.012 and 0) and similar improvements in pain intensity and functional status at other follow-up points. In addition, CBT resulted in significantly better surgical characteristics. Notably, CBT fixation led to lower incidence of screw loosening (P=0.006).

Conclusion: CBT-screw fixation for single-level lumbar fusion in patients with osteoporosis provided improvement in clinical symptoms comparable to that of TLIF using PS fixation. Significantly better lumbar stability was found in the CBT group. We suggest that CBT-screw fixation is a reasonable and superior alternative to PS in TLIF in osteoporosis.

Trial registration number: ChiCTR1900022658.

Date of registration: April 20, 2019.

Keywords: cortical bone-trajectory screw; lumbar fusion; osteoporosis; pedicle screw; randomized controlled trial.

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Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Radiological examination of one patient who had undergone CBT-fixation surgery with lumbar spinal stenosis at L4/5 segment with failure of conservative treatment. (A and B) Anteroposterior and lateral views of preoperation lumbar spine X-ray; (C) sagittal image of preoperation MRI scan; (D) L4/5-disk axial image of preoperation CT scan; (E) L4/5-disk axial image of preoperation MRI scan; (F and G) anteroposterior and lateral view lumbar spine X-ray at 3 months post-CBT fixation surgery; (H) sagittal CT image at 3 months postoperation for lumbar CT reconstruction, showing signs of fusion at L4/5; (I and J) cortical screw position in L4 and L5 vertebrae.
Figure 2
Figure 2
Radiological examination of one patient who had undergone PS fixation surgery with lumbar spinal stenosis at L4/5 with failure of conservative treatment. (A and B) Anteroposterior and lateral views of preoperation lumbar spine X-ray; (C) sagittal image of preoperation MRI scan; (D), L4/5-disk axial image of preoperation CT scan; (E) L4/5-disk axial image of preoperation MRI scan; (F and G) anteroposterior and lateral view of lumbar spine X-ray at 3 months post-PS fixation surgery; (H) sagittal image at 3 months postoperation of lumbar reconstruction CT scan, showing signs of fusion at L4/5; (I and J) pedicle-screw position in L4 and L5 vertebrae.
Figure 3
Figure 3
Flowchart of enrollment.
See this image and copyright information in PMC

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