The use of RhBMP-2 in single-level transforaminal lumbar interbody fusion: a clinical and radiographic analysis

Abstract

The "off label" use of rhBMP-2 in the transforaminal lumbar interbody fusion (TLIF) procedure has become increasingly popular. Although several studies have demonstrated the successful use of rhBMP-2 for this indication, uncertainties remain regarding its safety and efficacy. The purpose of this study is to evaluate the clinical and radiographic outcomes of the single-level TLIF procedure using rhBMP-2. Patients who underwent a single-level TLIF between January 2004 and May 2006 with rhBMP-2 were identified. A retrospective evaluation of these patients included operative report(s), pre- and postoperative medical records, and dynamic and static lumbar radiographs. Patient-reported clinical outcome measures were obtained from a telephone questionnaire and included a modification of the Odom's criteria, a patient satisfaction score, and back and leg pain numeric rating scale scores. Forty-eight patients met the study criteria and were available for follow-up (avg. radiographic and clinical follow-up of 19.4 and 27.4 months, respectively). Radiographic fusion was achieved in 95.8% of patients. Good to excellent results were achieved in 71% of patients. On most recent clinical follow-up, 83% of patients reported improvement in their symptoms and 84% reported satisfaction with their surgery. Twenty-nine patients (60.4%) reported that they still had some back pain, with an average back pain numeric rating score of 2.8. Twenty patients (41.7%) reported that they still had some leg pain, with an average leg pain numeric rating score was 2.4. Thirteen patients (27.1%) had one or more complications, including transient postoperative radiculitis (8/48), vertebral osteolysis (3/48), nonunion (2/48), and symptomatic ectopic bone formation (1/48). The use of rhBMP-2 in the TLIF procedure produces a high rate of fusion, symptomatic improvement and patient satisfaction. Although its use eliminates the risk of harvesting autograft, rhBMP-2 is associated with other complications that raise concern, including a high rate of postoperative radiculitis.