STUDY DESIGN: Prospective observational cohort study. PURPOSE: This study aims to evaluate the safety and efficacy of bone morphogenetic protein-2 (BMP-2) in transforaminal lumbar interbody fusion (TLIF) with regard to postoperative radiculitis. OVERVIEW OF LITERATURE: Bone morphogenetic protein (BMP) is being used increasingly as an alternative to iliac crest autograft in spinal arthrodesis. Recently, the use of BMP in TLIF has been examined, but concerns exist that the placement of BMP close to the nerve roots may cause postoperative radiculitis. Furthermore, prospective studies regarding the use of BMP in TLIF are lacking. METHODS: This prospective study included 77 patients. The use of BMP-2 was determined individually, and demographic and operative characteristics were recorded. Leg pain was assessed using the Visual Analog Scale (VAS) for pain and the Sciatica Bothersome Index (SBI) with several secondary outcome measures. The outcome data were collected at each follow-up visit. RESULTS: Among the 77 patients, 29 were administered with BMP. Postoperative leg pain significantly improved according to VAS leg and SBI scores for the entire cohort, and no clinically significant differences were observed between the BMP and control groups. The VAS back, Oswestry Disability Index, and Short-Form 36 scores also significantly improved. A significantly increased 6-month fusion rate was noted in the BMP group (82.8% vs. 55.3%), but no significant differences in fusion rate were observed at the 12- and 24-month follow-up. Heterotopic ossification was observed in seven patients: six patients and one patient in the BMP and control groups, respectively (20.7% vs. 2.1%). However, no clinical effect was observed. CONCLUSIONS: In this prospective observational trial, the use of BMP in TLIF did not lead to significant postoperative radiculitis, as measured by VAS leg and SBI scores. Back pain and other functional outcome scores also improved, and no differences existed between the BMP and control groups. The careful use of BMP in TLIF appears to be both safe and effective.
Arthrodesis ; Autografts ; Back Pain ; Bone Morphogenetic Proteins ; Cohort Studies ; Follow-Up Studies ; Humans ; Leg ; Lumbosacral Region ; Ossification, Heterotopic ; Outcome Assessment (Health Care) ; Prospective Studies ; Radiculopathy ; Sciatica ; Spinal Fusion ; Spine ; Visual Analog Scale

Methods: A cohort of 90 lumbar spine fusion patients were compared with 295 young, healthy patients obtained from a trauma da¬tabase. Cross-sectional vertebral body (VB) area, as well as the areas of the psoas and paravertebral muscles at mid-point of pedicles at L3 and L4 for both cohorts, was measured using axial CT imaging. Total muscle area-to-VB area ratio was calculated along with intraclass correlation coefficients for interobserver and intraobserver reliability. Finally, T-scores were calculated to help identify those patients with considerably diminished muscle-to-VB area ratios. Results: Both muscle mass and VB areas were considerably larger in males compared with those in females, and the ratio of these two measures was not enough to account for large differences. Thus, a gender-based comparison was made between spine patients and healthy control patients to establish T-scores that would help identify those patients with sarcopenia. The ratio for paravertebral muscle area-to-VB area at the L4 level was the only measure with good interobserver reliability, whereas the other three of the four ratios were moderate. All measurements had excellent correlations for intraobserver reliability. Conclusions We postulate that a patient with a T-score <−1 for total paravertebral muscle area-to-VB area ratio at the L4 level is the most reliable method of all our measurements that can be used to diagnose a patient undergoing lumbar spine surgery with sarcopenia.