Abstract
Background Mounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches).
Methods Patients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT 02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis.
Results A total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m2 (SD 6.5). At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. The surgical approach did not significantly impact fusion success. A significant (P < 0.0001) improvement in QoL, pain, and disability scores was also observed. Significant differences in the ODI, VAS, and EQ5D were observed between the treatment groups (P < 0.05).
Conclusions CBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches.
Clinical Relevance The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes.
Level of Evidence 4.
Trial Registration NCT 02969616.
Footnotes
Funding This study was supported by Orthofix (Lewisville, TX, USA).
Disclosures All authors have received research support from Orthofix. Hamid Hassanzadeh has received consulting fees from Globus/Nuvasive, Orthofix, and DePuy; honoraria from Globus/Nuvasive, DePuy, and Stryker; payment for expert testimony from Medtronic; and stock/stock options from Globus. Jung Yoo has received royalties or licenses from Osiris Therapeutic. Daniel Park reports grants or contracts from SeaSpine, Alphatec, and Orthofix and consulting fees from Stryker, Arthrex, Amplify, and Kuros. Anthony Russo reports royalties or licenses from Globus and consulting fees from Orthofix, Globus, and SeaSpine. Joshua Wind has received royalties or licenses from Zimmer Biomet; speaker honoraria from Orthofix; and participation on a data safety monitoring board or advisory board for Centinel, Spine BioPharma, Syngery Spine, Boston Scientific, Orthofix (cervical arthroplasty), and Empirical Spine.
Ethics Statement The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board at each respective clinical site for studies involving humans. Informed consent was obtained from all patients involved in the study.
Data Availability Statement Data supporting the findings of this study are available upon reasonable request.
- This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2024 ISASS. To see more or order reprints or permissions, see http://ijssurgery.com.
In this issue
Jump to section
Related Articles
Cited By...
- No citing articles found.