TY - JOUR
T1 - A prospective, multi-center clinical and radiographic outcomes evaluation of ChronOS strip for lumbar spine fusion
AU - Kanter, Adam S.
AU - Gandhoke, Gurpreet S.
AU - Welch, William C.
AU - Arnold, Paul M.
AU - Cheng, Joseph S.
AU - Okonkwo, David O.
N1 - Publisher Copyright:
© 2015 Elsevier Ltd. All rights reserved.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - This prospective clinical study evaluated the use of a composite bone void filler (ChronOS Strip, DePuy Synthes, West Chester, PA, USA), combined with bone marrow aspirate plus local autologous bone, in a series of patients undergoing instrumented posterolateral spinal fusion with interbody support. Seventy-six patients were enrolled and treated per protocol at 13 clinical sites. At 24 months, 55/76 patients (72%) were evaluated, with 49/76 (65%) having sufficient data to determine the primary endpoint. The primary endpoint, posterolateral fusion success, was achieved in 48/54 (88.9%) patients at 12 months and in 45/49 (91.8%) patients at 24 months. At all follow-up time points, statistically significant improvements were observed when compared to baseline in back and leg pain and functional status as measured by visual analog scale, Oswestry Disability Index and 12-Item Short Form health surveys. This prospective multi-center series provides evidence that the composite bone void filler, when applied posterolaterally with instrumentation, bone marrow aspirate and/or local autologous bone and concomitant interbody support, can be used to achieve a successful posterolateral fusion, resulting in improvements in clinical outcomes in patients with degenerative disc disease.
AB - This prospective clinical study evaluated the use of a composite bone void filler (ChronOS Strip, DePuy Synthes, West Chester, PA, USA), combined with bone marrow aspirate plus local autologous bone, in a series of patients undergoing instrumented posterolateral spinal fusion with interbody support. Seventy-six patients were enrolled and treated per protocol at 13 clinical sites. At 24 months, 55/76 patients (72%) were evaluated, with 49/76 (65%) having sufficient data to determine the primary endpoint. The primary endpoint, posterolateral fusion success, was achieved in 48/54 (88.9%) patients at 12 months and in 45/49 (91.8%) patients at 24 months. At all follow-up time points, statistically significant improvements were observed when compared to baseline in back and leg pain and functional status as measured by visual analog scale, Oswestry Disability Index and 12-Item Short Form health surveys. This prospective multi-center series provides evidence that the composite bone void filler, when applied posterolaterally with instrumentation, bone marrow aspirate and/or local autologous bone and concomitant interbody support, can be used to achieve a successful posterolateral fusion, resulting in improvements in clinical outcomes in patients with degenerative disc disease.
KW - Beta-tricalcium phosphates
KW - Bone marrow aspirate
KW - Posterolateral fusion
UR - http://www.scopus.com/inward/record.url?scp=84956577725&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84956577725&partnerID=8YFLogxK
U2 - 10.1016/j.jocn.2015.08.012
DO - 10.1016/j.jocn.2015.08.012
M3 - Article
C2 - 26602602
AN - SCOPUS:84956577725
SN - 0967-5868
VL - 25
SP - 36
EP - 40
JO - Journal of Clinical Neuroscience
JF - Journal of Clinical Neuroscience
ER -