TY - JOUR
T1 - Efficacy of a Standalone Microporous Ceramic Versus Autograft in Instrumented Posterolateral Spinal Fusion
T2 - A Multicenter, Randomized, Intrapatient Controlled, Noninferiority Trial
AU - Lehr, Mechteld
AU - Oner, Cumhur
AU - Delawi, Diyar
AU - Stellato, Rebecca K
AU - Hoebink, Eric A
AU - Kempen, Diederik H R
AU - van Susante, Job L C
AU - Castelein, Rene M
AU - Kruyt, Moyo C
N1 - Publisher Copyright:
© 2020 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2020/7/15
Y1 - 2020/7/15
N2 - Study Design.in the rest of the article written as patient- and observer-blinded, multicenter, randomized, intrapatient controlled, noninferiority trial.Objective.The aim of this study was to determine noninferiority of a biphasic calcium-phosphate (AttraX® Putty) as a bone graft substitute for autograft in instrumented posterolateral fusion (PLF).Summary of Background Data.Spinal fusion with autologous bone graft is a frequently performed surgical treatment. Several drawbacks of autografting have driven the development of numerous alternatives including synthetic ceramics. However, clinical evidence for the standalone use of these materials is limited.Methods.This study included 100 nontraumatic adults who underwent a primary, single- or multilevel, thoracolumbar, instrumented PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX® Putty was disclosed. Autograft was applied to the contralateral side of the fusion trajectory, so each patient served as his/her own control. For the primary efficacy outcome, PLF was assessed at 1-year follow-up on computed tomography scans. Each segment and side was scored as fused, doubtful fusion, or nonunion. After correction for multilevel fusions, resulting in a single score per side, the fusion performance of AttraX
® Putty was tested with a noninferiority margin of 15% using a 90% confidence interval (CI).Results.There were 49 males and 51 females with a mean age of 55.4 ± 12.0 (range 27-79) years. Two-third of the patients underwent a single-level fusion and 62% an additional interbody fusion procedure. The primary analysis was based on 87 patients, including 146 instrumented segments. The fusion rate of AttraX
® Putty was 55% versus 52% at the autograft side, with an overall fusion rate of 71%. The 90% CI around the difference in fusion performance excluded the noninferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%).Conclusion.The results of this noninferiority trial support the use of AttraX
® Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar PLF.Level of Evidence: 1.
AB - Study Design.in the rest of the article written as patient- and observer-blinded, multicenter, randomized, intrapatient controlled, noninferiority trial.Objective.The aim of this study was to determine noninferiority of a biphasic calcium-phosphate (AttraX® Putty) as a bone graft substitute for autograft in instrumented posterolateral fusion (PLF).Summary of Background Data.Spinal fusion with autologous bone graft is a frequently performed surgical treatment. Several drawbacks of autografting have driven the development of numerous alternatives including synthetic ceramics. However, clinical evidence for the standalone use of these materials is limited.Methods.This study included 100 nontraumatic adults who underwent a primary, single- or multilevel, thoracolumbar, instrumented PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX® Putty was disclosed. Autograft was applied to the contralateral side of the fusion trajectory, so each patient served as his/her own control. For the primary efficacy outcome, PLF was assessed at 1-year follow-up on computed tomography scans. Each segment and side was scored as fused, doubtful fusion, or nonunion. After correction for multilevel fusions, resulting in a single score per side, the fusion performance of AttraX
® Putty was tested with a noninferiority margin of 15% using a 90% confidence interval (CI).Results.There were 49 males and 51 females with a mean age of 55.4 ± 12.0 (range 27-79) years. Two-third of the patients underwent a single-level fusion and 62% an additional interbody fusion procedure. The primary analysis was based on 87 patients, including 146 instrumented segments. The fusion rate of AttraX
® Putty was 55% versus 52% at the autograft side, with an overall fusion rate of 71%. The 90% CI around the difference in fusion performance excluded the noninferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%).Conclusion.The results of this noninferiority trial support the use of AttraX
® Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar PLF.Level of Evidence: 1.
KW - adult
KW - autograft
KW - bone graft substitute
KW - calcium phosphate
KW - intra-patient
KW - non-inferiority
KW - posterolateral fusion
KW - randomized controlled trial
KW - spinal fusion
UR - http://www.scopus.com/inward/record.url?scp=85087469343&partnerID=8YFLogxK
U2 - 10.1097/BRS.0000000000003440
DO - 10.1097/BRS.0000000000003440
M3 - Article
C2 - 32080013
SN - 0362-2436
VL - 45
SP - 944
EP - 951
JO - Spine
JF - Spine
IS - 14
ER -