Article Figures & Data
Figures
- Figure
Kaplan-Meier survivorship curve for days to reoperation between patients who received recombinant human bone morphogenetic protein 2 (BMP) and those who did not in the index surgery. Abbreviation: Cum, cumulative.
Tables
Demographics No BMP BMP Total P N 67 (45.3%) 81 (54.7%) 148 Age, y 60.4 ± 11.7 58.5 ± 12.0 59.3 ± 11.9 0.339 Female gender 39 (56.7%) 39 (48.1%) 77 (52.0%) 0.299 Body mass index 28.2 ± 5.7 30.0 ± 8.3 29.2 ± 7.3 0.125 Current/past smoker 26 (38.8%) 33 (40.7%) 59 (39.9%) 0.811 Charlson Comorbidity Index 2.8 ± 2.5 2.2 ± 1.5 2.5 ± 2.1 0.113 Diabetes mellitus 11 (16.4%) 10 (12.3%) 21 (14.2%) 0.480 Diabetes with end-organ damage 3 (4.5%) 2 (2.5%) 5 (3.4%) 0.501 History of chronic obstructive pulmonary disease 5 (7.5%) 5 (6.2%) 10 (6.8%) 0.756 American Society of Anesthesiologists classification 2.3 ± 0.7 2.3 ± 0.6 2.3 ± 0.6 0.818 Days of follow-up 560.3 ± 275.4 790.4 ± 440.2 686.2 ± 390.8 <0.001 Abbreviations: BMP, recombinant human bone morphogenetic protein 2; TLIF, transforaminal lumbar interbody fusion.
Note: Data presented as n (%) or mean ± SD.
- Table 2
Comparison of surgical outcomes among single-level TLIFs with and without BMP use.
Surgical Outcomes No BMP BMP Total P Operative time, min 219.1 ± 60.2 220.6 ± 70.7 219.9 ± 65.9 0.894 Estimated blood loss, mL 257.3 ± 206.6 169.6 ± 133.2 209.0 ± 175.0 0.002 Fluoroscopic dosage, mGy 54.6 ± 42.2 54.9 ± 57.1 54.8 ± 51.6 0.973 Tranexamic acid, mL 1746.7 ± 1074.2 2152.2 ± 979.5 1922.4 ± 1037.0 0.297 Intraoperative complications 4 (6.0%) 4 (4.9%) 8 (5.4%) 0.782 Durotomy 2 (3.0%) 2 (2.5%) 4 (2.7%) 0.847 Neuromonitoring changes 2 (3.0%) 2 (2.5%) 4 (2.7%) 0.847 BMP volume, mL 0 ± 0 1.5 ± 0.4 1.5 ± 0.4 <0.001 Cancellous allograft use 6 (9.0%) 6 (7.4%) 12 (8.1%) 0.731 Cancellous allograft volume, mL 32.1 ± 8.2 38.0 ± 18.7 36.8 ± 17.2 0.182 Local autograft use 46 (68.7%) 73 (90.1%) 119 (80.4%) 0.001 Iliac crest bone graft use 0 (0.0%) 7 (8.6%) 7 (4.7%) 0.014 Demineralized bone matrix use 6 (9.0%) 6 (7.4%) 12 (8.1%) 0.731 Bone marrow aspirate use 8 (11.9%) 16 (29.8%) 24 (16.2%) 0.199 Cellular bone allograft 35 (52.2%) 4 (4.9%) 39 (26.4%) <0.001 Expandable cage use 33 (34.4%) 63 (77.8%) 96 (64.9%) <0.001 Length of stay, d 3.5 ± 3.1 3.0 ± 2.1 3.2 ± 2.6 0.219 Abbreviations: BMP, recombinant human bone morphogenetic protein 2; TLIF, transforaminal lumbar interbody fusion.
Note: Data presented as n (%) or mean ± SD.
- Table 3
Comparison of perioperative complications among single-level TLIFs with and without BMP use.
Postoperative Complications No BMP BMP Total P Postoperative complications 0–90 d 15 (22.4%) 12 (14.8%) 27 (18.2%) 0.235 Wound complications 0–90 d 1 (1.5%) 0 (0.0%) 1 (0.7%) 0.270 Medical complications 0–90 d 5 (7.5%) 4 (4.9%) 9 (6.1%) 0.522 Neurological complication 0–90 d 3 (4.5%) 5 (6.2%) 8 (5.4%) 0.650 Complications at 90-d Follow-Up Any readmission to follow-up 11 (16.4%) 8 (9.9%) 19 (12.8%) 0.236 All postoperative complications or readmission to follow-up 29 (43.3%) 26 (32.1%) 55 (37.2%) 0.161 Any neurological complications postoperative follow-up 20 (29.9%) 17 (21.0%) 37 (25.0%) 0.215 Motor weakness 2 (3.0%) 1 (1.2%) 3 (2.0%) 0.452 Stenosis 0 (0.0%) 1 (1.2%) 1 (0.7%) 0.361 Radiculopathy 13 (19.4%) 8 (9.9%) 21 (14.2%) 0.098 Radiculopathy resolved spontaneously without surgery 3 (23.1%) 2 (25.0%) 5 (23.8%) 0.920 Sensory deficit 2 (3.0%) 3 (3.7%) 5 (3.4%) 0.810 Persistent pain 4 (6.0%) 3 (3.7%) 7 (4.7%) 0.518 Pseudarthrosis at a minimum of 1-y follow-up 5 (7.5%) 5 (6.2%) 10 (6.8%) 0.756 0–1 y 1 (1.5%) 2 (2.5%) 3 (2.0%) 0.549 1–2 y 4 (6.0%) 2 (2.5%) 6 (4.1%) 2+ y 0 (0.0%) 1 (1.2%) 1 (0.7%) Medical complications, postoperative to follow-up 5 (7.5%) 4 (4.9%) 9 (6.1%) 0.522 Wound complications, postoperative to follow-up 2 (3.0%) 1 (1.2%) 3 (2.0%) 0.452 Abbreviations: BMP, recombinant human bone morphogenetic protein 2; TLIF, transforaminal lumbar interbody fusion.
Note: Data presented as n (%).
Reoperation No BMP BMP Total P Return to OR 30 d 2 (3.0%) 3 (3.7%) 5 (3.4%) 0.810 Return to OR 90 d 3 (4.5%) 3 (3.7%) 6 (4.1%) 0.812 Return to OR to follow-up 12 (17.9%) 9 (11.1%) 21 (14.2%) 0.238 Levels Involved Reoperation at the same level as index surgery 11 (16.4%) 9 (9.9%) 19 (12.8%) 0.236 Reoperation at the adjacent level of index surgery 5 (7.5%) 4 (4.9%) 9 (6.1%) 0.522 Reason for reoperation Any neurological symptom 10 (14.9%) 8 (9.9%) 18 (12.2%) 0.350 Pseudarthrosis 5 (7.5%) 3 (3.7%) 8 (5.4%) 0.314 Adjacent segment stenosis 5 (7.5%) 4 (4.9%) 9 (6.1%) 0.522 Central or foraminal stenosis 3 (4.5%) 5 (6.2%) 8 (5.4%) 0.65 Wound infection/complication 0 (0.0%) 1 (1.2%) 1 (0.7%) 0.361 Instrumentation (migration/prominence/failure) 0 (0.0%) 1 (1.2%) 1 (0.7%) 0.361 Hematoma/seroma 0 (0.0%) 1 (1.2%) 1 (0.7%) 0.361 Days to revision surgery 400.3 ± 260.4 394.6 ± 297.0 398.0 ± 267.9 0.965 Abbreviations: BMP, recombinant human bone morphogenetic protein 2; OR, operating room; TLIF, transforaminal lumbar interbody fusion.
Note: Reoperations and reason for reoperation were recorded by clinical and operative notes at the study institution.
- Table 5
Comparison of single-level transforaminal lumbar interbody fusions that underwent reoperation for pseudarthrosis vs those that did not.
Variable No Pseudarthrosis Reoperation Reoperation for Pseudarthrosis Total P N 140 (94.6%) 8 (5.4%) 148 Demographic Characteristics Age, y 59.6 ± 11.8 55.1 ± 12.9 59.3 ± 11.9 0.304 18–29 0 (0%) 0 (0%) 0 (0%) 0.876 30–41 10 (7.1%) 1 (9.1%) 11 (7.4%) 42–53 34 (24.3%) 2 (25.0%) 36 (24.3%) 54–65 44 (31.4%) 3 (37.5%) 47 (31.8%) ≥66 52 (37.1%) 2 (25.0%) 54 (36.5%) Female Gender 74 (52.9%) 3 (37.5%) 77 (52.0%) 0.398 BMI 29.0 ± 7.2 32.7 ± 8.5 39.2 ± 7.3 0.155 Current/past smoker 55 (39.3%) 4 (50.0%) 59 (399%) 0.547 Charlson Comorbidity Index 2.4 ± 2.1 2.9 ± 2.2 2.4 ± 2.1 0.565 Diabetes mellitus 18 (12.9%) 3 (37.5%) 21 (14.2%) 0.052 Diabetes with end-organ damage 2 (1.4%) 3 (37.5%) 5 (3.5%) <0.001 History of COPD 8 (5.7%) 2 (25.0%) 10 (6.8%) 0.035 American Society of Anesthesiologist classification 2.2 ± 0.6 2.5 ± 0.9 2.3 ± 0.6 0.298 Days of follow-up 679.3 ± 295.1 806.9 ± 299.9 686.2 ± 390.8 0.371 Index Surgery Operative Characteristics Operative time, min 218.1 ± 63.5 251.8 ± 98.7 219.9 ± 65.9 0.160 Estimated blood loss, mL 208.0 ± 178.8 225.0 ± 92.6 208.9 ± 175.0 0.791 Fluoroscopic dosage, mGy 50.8 ± 45.8 110.5 ± 91.2 54.8 ± 51.6 0.003 BMP use 78 (55.7%) 3 (37.5%) 81 (54.7%) 0.314 Average BMP volume, mL 1.5 ± 0.4 1.4 ± 0.0 1.5 ± 0.4 0.565 Cancellous allograft use 98 (70.0%) 5 (62.5%) 103 (69.3%) 0.654 Cancellous allograft volume, mL 37.1 ± 17.6 33.0 ± 6.7 36.8 ± 17.2 0.612 Local autograft use 113 (80.7%) 6 (75.0%) 119 (80.4%) 0.692 Iliac crest bone graft use 6 (4.3%) 1 (12.5%) 8 (4.7%) 0.287 Demineralized bone matrix use 12 (8.6%) 0 (0.0%) 12 (8.1%) 0.388 Tranexamic acid, mL 1776.9 ± 961.4 3240.2 ± 827.0 1922.4 ± 1037.0 0.017 Bone marrow aspirate use 22 (15.7%) 2 (25.0%) 24 (16.2%) 0.488 Cellular bone allograft 37 (26.4%) 2 (25.0%) 39 (26.4%) 0.929 Expandable cage use 90 (64.3%) 6 (75.0%) 96 (64.9%) 0.537 Length of stay, d 3.2 ± 2.7 4.3 ± 1.8 3.2 ± 2.6 0.261 Pseudarthrosis at a minimum of 1 y follow-up 2 (1.4%) 8 (80%) 10 (6.8%) < 0.001 0–1 y 1 (0.75%) 2 (25.0%) 3 (2.0%) < 0.001 1–2 y 1 (0.7%) 5 (62.5%) 6 (4.1%) 2+ y 0 (0.0%) 1 (12.5%) 1 (0.7%) Days to revision surgery 305.8 ± 279.3 536.3 ± 189.1 398.0 ± 267.9 0.057 Neurological Symptoms After Index Surgery Motor deficit 2 (1.4%) 1 (12.5%) 3 (2.0%) 0.031 Stenosis 1 (0.7%) 0 (0.0%) 0 (0.0%) 0.810 Radiculopathy 19 (13.6%) 2 (25.0%) 21 (14.2%) 0.368 Radiculopathy resolved spontaneously without surgery 5 (26.3%) 0 (0.0%) 5 (23.8%) 0.406 Sensory deficit 3 (2.1%) 2 (25.0%) 5 (3.4%) <0.001 Persistent pain 7 (5.0%) 0 (0.0%) 7 (4.7%) 0.517 Abbreviations: BMI, body mass index; COPD, chronic obstructive pulmonary disease; TLIF, transforaminal lumbar interbody fusion.
Note: Data presented as n (%) or mean ± SD.
Variable OR (95 % CI) P BMP use 0.2 (0.01–3.7) 0.269 Age 18–41 y (ref: age >41 y) 0.6 (0.03–15.2) 0.782 Smoking history 2.2 (0.3–18.1) 0.461 History of COPD 7.8 (0.4–147.5) 0.170 Diabetes with end-organ damage 112.6 (5.7–2225.8） 0.002 Bone marrow aspirate use 1.1 (0.1–15.9） 0.918 Local autograft use 0.3 (0.02–4.1） 0.346 Iliac crest bone graft use 21.9 (0.7–694.5） 0.080 Cellular bone allograft use 0.4 (0.02–7.3) 0.534 Expandable cage use 2.6 (0.3–25.5) 0.412 ASA classification>3 (ref: ≤3) 0.6 (0.001–391.0) 0.874 Abbreviations: ASA, American Society of Anesthesiologists; BMP, recombinant human bone morphogenetic protein 2; COPD, chronic obstructive pulmonary disease; ref, reference.
Note: Values in boldface represent statistical significance at P < 0.05. Nagelkerke R 2 = 0.381. Hosmer Lemeshow test P = 0.731.
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