rhBMP-2 for Posterolateral Instrumented Lumbar Fusion A Multicenter Prospective Randomized Controlled Trial

被引:31
作者
Hurlbert, R. John [1 ,2 ]
Alexander, David [3 ]
Bailey, Stewart [4 ]
Mahood, James [5 ]
Abraham, Ed [6 ]
McBroom, Robert [7 ]
Jodoin, Alain [8 ]
Fisher, Charles [9 ]
机构
[1] Univ Calgary, Spine Program, Calgary, AB, Canada
[2] Univ Calgary, Dept Clin Neurosci, Calgary, AB, Canada
[3] Dalhousie Univ, Div Orthoped Surg, Halifax, NS, Canada
[4] Univ Western Ontario, Div Orthoped Surg, London, ON, Canada
[5] Univ Alberta, Div Orthoped Surg, Edmonton, AB, Canada
[6] Dalhousie Univ, Div Orthoped Surg, St John, NB, Canada
[7] Trillium Hlth Ctr, Div Orthoped Surg, Mississauga, ON, Canada
[8] Univ Montreal, Div Orthoped Surg, Montreal, PQ, Canada
[9] Univ British Columbia, Div Orthoped Surg, Vancouver, BC V5Z 1M9, Canada
关键词
spine; BMP; osteoinduction; degenerative disease; degenerative disc disease; bone graft; stability; arthrodesis; BONE MORPHOGENETIC PROTEIN-2; SPINAL-FUSION; CLINICAL-OUTCOMES; ARTHRODESIS; GRAFT; AUTOGRAFT; RABBIT; CAGES;
D O I
10.1097/BRS.0000000000000007
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Study Design. Multicenter randomized controlled trial. Objective. To evaluate the effect of recombinant human bone morphogenetic protein (rhBMP-2) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft. Summary of Background Data. In many types of spinal surgery, radiographical fusion is a primary outcome equally important to clinical improvement, ensuring long-term stability and axial support. Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective. We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion. Methods. Patients undergoing 1- or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct. Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively. Results. One hundred ninety seven patients were successfully randomized among the 8 participating institutions. Adverse events attributable to the study drug were not significantly different compared with controls. However, the control group experienced significantly more graft-site complications as might be expected. 36-Item Short Form Health Survey, Oswestry Disability Index, and leg/back pain scores were comparable between the 2 groups. After 4 years of follow-up, radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 (94%) than those who received autograft (69%) (P = 0.007). Conclusion. The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft. However, there is no associated improvement in clinical outcome within a 4-year follow-up period. These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern.
引用
收藏
页码:2139 / 2148
页数:10
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