Clinical evaluation of a growth factor bioavailability enhanced allograft in anterior lumbar interbody fusion (ALIF)

Interbody fusion, especially anterior lumbar interbody fusion (ALIF), is a common treatment for spinal conditions like degenerative disc disease (DDD). Various graft materials, including autografts, allografts, and synthetic substitutes, are used to facilitate fusion, though each has limitations. A novel growth factor bioavailability-enhanced allograft (GFBA) has been introduced, which aims to enhance fusion outcomes by unlocking critical growth factors in the bone matrix.

Consecutive patients who received treatment with GFBA at a single site between January 2022 and December 2022 were invited to participate prior to 12 months postoperative assessment. Those who consented were evaluated prospectively by computed tomography (CT), flexion extension X-ray, and completed questionnaires regarding pain and disability.

Fifty patients (64 treated levels), with a mean age of 61.5 years old, 62.0% female, and a mean body mass index (BMI) of 31.0 kg/m² participated. Thirty-six patients (72.0%) underwent single level ALIF, and 14 (28.0%) underwent two-level ALIFs. All subjects (100%) had less than three degrees of motion upon flexion extension. CT scans showed complete bridging bone with no evidence of supplemental fixation failure for 89.1% of levels (defined as 3A), with the remaining 10.9% showing bone growth from both end plates and no sign of supplemental fixation failure (defined as 2A). Statistically significant improvements were observed in low back pain (60.1 to 29.6), left leg pain (33.8 to 21.4), and right leg pain (40.2 to 18.4), all P<0.05. No GFBA-related complications or revision/reoperations were reported.

This study evaluated a novel GFBA and reported similar fusion rates to published reports of iliac crest bone graft (ICBG). Significant clinical improvements and no GFBA related complications or revision/reoperations were reported. This is the first study evaluating GFBA and demonstrated its safety and efficacy in ALIF procedures for DDD.