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

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

Abbreviations

CBT, cortical bone trajectory; PS, pedicle screw; TLIF, transforaminal lumbar interbody fusion; VAS, visual analogue scale; ODI, Oswestry Disability Index; JOA, Japanese Orthopaedic Association; BMI, body-mass index; BMD, bone-mineral density.

Data Sharing Statement

The research is ongoing, and the authors are not allowed to share detailed data before the project finishes. If readers are interested in the relevant data, they can obtain these from the corresponding author after permission.

Ethics Approval and Informed Consent

The studies were approved by the institutional ethics committee of Beijing Chaoyang Hospital (2019-KE-2). All procedures involving human participants were in accordance with the ethical standards of the institutional and/or national research committee, the 1964 Declaration of Helsinki, and its later amendments, or comparable ethical standards. Informed consent was obtained from all participants.

Author Contributions

All authors made a significant contribution to the work reported, whether in conception, study design, execution, acquisition of data, analysis and interpretation, or all these areas, took part in drafting, revising, or critically reviewing the article, gave final approval to the version to be published, have agreed on the journal to which the article has been submitted, and agree to be accountable for all aspects of the work.

Disclosure

The authors declare that they have no conflicts of interest.

Additional information

Funding

The study received funding support from Beijing Natural Science Funds (Haidian Original Innovation Joint Fund L202006).