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, pedicle screw, lumbar fusion, osteoporosis, randomized controlled trial