Application of New Allogeneic Lumbar Fusion Cage (Biocage) in Single-Segment Lumbar Degenerative Disease: A Prospective Controlled Study with Follow-Up for ≥2 Years.

OBJECTIVE

We evaluated the clinical efficacy of the Biocage in lumbar fusion surgery and its safety and effectiveness.

METHODS

A total of 431 patients with single-segment lumbar degenerative disease diagnosed from January 2013 to December 2016 were considered for the present prospective, nonrandomized, and controlled study; 52 patient met the exclusion criteria and were excluded. The patients were divided into 2 groups according to their cage choice: Biocage (n = 206) and polyether ether ketone (PEEK) cage (n = 173). The patients were followed up for 24-48 months (average, 32). The operative time, blood loss, hospitalization duration, mean intervertebral fusion segment height, height of intervertebral foramen, fusion time, fusion rate, internal fixation failure rate, visual analog scale score, and Oswestry disability index were compared between the 2 groups.

RESULTS

All the patients underwent surgery successfully. No significant differences were found in gender, age, clinical diagnosis, lesion segment, operative time, blood loss, visual analog scale score, or Oswestry disability index between the 2 groups. No significant differences were found in the fusion rate; however, the Biocage group had a greater fusion rate and shorter fusion time than the PEEK group. During follow-up, the mean intervertebral height recovered significantly in the Biocage group compared with the PPEK group (P < 0.05). The height of the intervertebral foramen was significantly different between the 2 groups, and recovery was better in the Biocage group (P < 0.05). The Cobb angle of fusion segment in both groups improved significantly postoperatively compared with preoperatively (P < 0.05). The improvement in Cobb angle was significantly different between the 2 groups (P < 0.05).

CONCLUSIONS

The Biocage has excellent clinical efficacy in the treatment of lumbar degenerative disease. Although the Biocage achieved good therapeutic effects, it did not show obvious advantages compared with the PEEK cage. Therefore, the Biocage can only be used as a choice of bone graft materials for lumbar fusion surgery and should not completely replace the PEEK cage.