BACKGROUND CONTEXT: In a large series of human patients undergoing open anterior lumbar interbody fusion with a tapered titanium fusion cage, recombinant human bone morphogenetic protein type 2 (rhBMP-2) on an absorbable collagen sponge carrier has been shown to decrease operative time and blood loss, to promote osteoinduction and fusion and to be a safe and effective substitute for iliac crest harvesting. PURPOSE: The purpose of the study was to determine the clinical and radiographic outcomes in patients treated for single-level degenerative lumbar disc disease with a posterior interbody fusion, using stand-alone cylindrical threaded titanium fusion cages with eitherautogenous bone graft or rhBMP-2 and an absorbable collagen sponge carrier. STUDY DESIGN/ SETTING: A prospective, randomized, nonblinded, 2-year pilot study at 14 investigational sites. PATIENT SAMPLE: Between March 1999 and December 1999, 67 patients with symptomatic, single-level degenerative lumbar disc disease of at least 6 months' duration underwent a single-level posterior lumbar interbody fusion using two paired cylindrical threaded titanium fusion devices. Patients were randomly assigned to one of two groups: one (n=34 patients) received rhBMP-2 on a collagen sponge carrier; the other (n=33 patients) autogenous iliac crest bone graft. OUTCOME MEASURES: Clinical outcomes were measured using low back and leg pain numerical rating scales, the Short Form (SF)-36, Oswestry Low Back Pain Disability Questionnaire and work status. Plain radiographs and computed tomographic scans were used to evaluate fusion at 6, 12 and 24 months after surgery. METHODS: In this prospective nonblinded study, 67 patients were randomly assigned to one of two groups who underwent interbody fusion using two cylindrical threaded fusion cages: the investigational group (34 patients), who received rhBMP-2 on an absorbable collagen sponge, and a control group (33 patients), who received autogenous iliac crest bone graft. Clinical data were collected and analyzed by a commercial entity. RESULTS: The mean operative time and blood loss for the investigational rhBMP-2 group was 2.6 hours and 322.8 ml, respectively. For the autograft control group, these values were 3.0 hours and 372.7 ml. The differences were not significant. Although not statistically different, at 24 months, the investigational group's fusion rate of 92.3% was higher than the control's at 77.8%. At all postoperative intervals, the mean Oswestry, back and leg pain scores and physical components of the SF-36 improved in both treatment groups compared with preoperative scores, but no significant differences were found between groups. A statistically significant difference in the change in back pain was found at 24 months for the investigational group. In the control group, two adverse events related to harvesting of the iliac crest graft occurred in two patients (6.1%). CONCLUSIONS: This small multicenter, randomized, nonblinded trial showed few statistically significant differences between the study groups. Both groups showed comparable improvements on outcome scores. Overall results show that the use of rhBMP-2 can eliminate the need for harvesting iliac crest graft and may be an equivalent replacement for autograft for use in successful posterior lumbar interbody fusions. Further studies of the use of rhBMP-2 in posterior lumbar interbody fusion cage procedures are needed.
RCT Entities:
BACKGROUND CONTEXT: In a large series of humanpatients undergoing open anterior lumbar interbody fusion with a tapered titanium fusion cage, recombinant human bone morphogenetic protein type 2 (rhBMP-2) on an absorbable collagen sponge carrier has been shown to decrease operative time and blood loss, to promote osteoinduction and fusion and to be a safe and effective substitute for iliac crest harvesting. PURPOSE: The purpose of the study was to determine the clinical and radiographic outcomes in patients treated for single-level degenerative lumbar disc disease with a posterior interbody fusion, using stand-alone cylindrical threaded titanium fusion cages with either autogenous bone graft or rhBMP-2 and an absorbable collagen sponge carrier. STUDY DESIGN/ SETTING: A prospective, randomized, nonblinded, 2-year pilot study at 14 investigational sites. PATIENT SAMPLE: Between March 1999 and December 1999, 67 patients with symptomatic, single-level degenerative lumbar disc disease of at least 6 months' duration underwent a single-level posterior lumbar interbody fusion using two paired cylindrical threaded titanium fusion devices. Patients were randomly assigned to one of two groups: one (n=34 patients) received rhBMP-2 on a collagen sponge carrier; the other (n=33 patients) autogenous iliac crest bone graft. OUTCOME MEASURES: Clinical outcomes were measured using low back and leg pain numerical rating scales, the Short Form (SF)-36, Oswestry Low Back Pain Disability Questionnaire and work status. Plain radiographs and computed tomographic scans were used to evaluate fusion at 6, 12 and 24 months after surgery. METHODS: In this prospective nonblinded study, 67 patients were randomly assigned to one of two groups who underwent interbody fusion using two cylindrical threaded fusion cages: the investigational group (34 patients), who received rhBMP-2 on an absorbable collagen sponge, and a control group (33 patients), who received autogenous iliac crest bone graft. Clinical data were collected and analyzed by a commercial entity. RESULTS: The mean operative time and blood loss for the investigational rhBMP-2 group was 2.6 hours and 322.8 ml, respectively. For the autograft control group, these values were 3.0 hours and 372.7 ml. The differences were not significant. Although not statistically different, at 24 months, the investigational group's fusion rate of 92.3% was higher than the control's at 77.8%. At all postoperative intervals, the mean Oswestry, back and leg pain scores and physical components of the SF-36 improved in both treatment groups compared with preoperative scores, but no significant differences were found between groups. A statistically significant difference in the change in back pain was found at 24 months for the investigational group. In the control group, two adverse events related to harvesting of the iliac crest graft occurred in two patients (6.1%). CONCLUSIONS: This small multicenter, randomized, nonblinded trial showed few statistically significant differences between the study groups. Both groups showed comparable improvements on outcome scores. Overall results show that the use of rhBMP-2 can eliminate the need for harvesting iliac crest graft and may be an equivalent replacement for autograft for use in successful posterior lumbar interbody fusions. Further studies of the use of rhBMP-2 in posterior lumbar interbody fusion cage procedures are needed.