TY - JOUR
T1 - Cobalt-chromium versus titanium alloy rods for correction of adolescent idiopathic scoliosis based on 1-year follow-up
T2 - A multicenter randomized controlled clinical trial
AU - Sakai, Daisuke
AU - Tanaka, Masato
AU - Takahashi, Jun
AU - Taniguchi, Yuki
AU - Schol, Jordy
AU - Hiyama, Akihiko
AU - Misawa, Haruo
AU - Kuraishi, Shugo
AU - Oba, Hiroki
AU - Matsubayashi, Yoshitaka
AU - Kato, So
AU - Sugawara, Ryo
AU - Sato, Masato
AU - Watanabe, Masahiko
AU - Takeshita, Katsushi
N1 - Publisher Copyright:
© 2021 American Association of Neurological Surgeons. All rights reserved.
PY - 2021/6
Y1 - 2021/6
N2 - OBJECTIVE For instrumented correction surgery for adolescent idiopathic scoliosis (AIS), surgeons are increasingly switching from titanium (Ti) alloy rods to stiffer cobalt-chromium (CoCr) rods. The authors conducted the first multicenter randomized controlled clinical trial to investigate whether these materials affect the outcomes in terms of spine correction and quality of life (QOL). This trial was registered at UMIN Clinical Trials Registry on September 3, 2012, under the identifier UMIN000008838 (level of evidence 1). METHODS Female AIS patients (Lenke types 1-3, patient age 10-19 years) were recruited at 5 Japanese institutions and randomized into two cohorts: 6.0-mm-diameter Ti rods were placed in one group, and 6.0-mm-diameter CoCr rods were placed in the other. Patients were followed up at 2 weeks and 3, 6, and 12 months with radiographic examination to quantify the sagittal and coronal correction (Cobb angle, thoracic kyphosis, rib hump, and apical vertebral rotation). Patients completed questionnaires (Scoliosis Research Society-22r, 12-Item Short-Form Health Survey, and Scoliosis Japanese Questionnaire-27) at 6 and 12 months to assess QOL. RESULTS A total of 69 AIS patients were randomized to the demographically similar Ti (n = 37) or CoCr (n = 32) cohort. Four adverse events were recorded, two in each cohort, but these were not related to the rod material. At the final followup, both Ti and CoCr cohorts showed significant improvement in spinal correction, including the Cobb angle, thoracic kyphosis, and rib hump size. The correction rates were 68.4% and 67.1% for the Ti and CoCr cohorts, respectively. No parameters differed significantly between the cohorts at any time. Survey data showed improved but similar outcomes in both cohorts. CONCLUSIONS Both treatments (Ti and CoCr) produced similar results and were efficient in engendering clinically significant spine corrections.
AB - OBJECTIVE For instrumented correction surgery for adolescent idiopathic scoliosis (AIS), surgeons are increasingly switching from titanium (Ti) alloy rods to stiffer cobalt-chromium (CoCr) rods. The authors conducted the first multicenter randomized controlled clinical trial to investigate whether these materials affect the outcomes in terms of spine correction and quality of life (QOL). This trial was registered at UMIN Clinical Trials Registry on September 3, 2012, under the identifier UMIN000008838 (level of evidence 1). METHODS Female AIS patients (Lenke types 1-3, patient age 10-19 years) were recruited at 5 Japanese institutions and randomized into two cohorts: 6.0-mm-diameter Ti rods were placed in one group, and 6.0-mm-diameter CoCr rods were placed in the other. Patients were followed up at 2 weeks and 3, 6, and 12 months with radiographic examination to quantify the sagittal and coronal correction (Cobb angle, thoracic kyphosis, rib hump, and apical vertebral rotation). Patients completed questionnaires (Scoliosis Research Society-22r, 12-Item Short-Form Health Survey, and Scoliosis Japanese Questionnaire-27) at 6 and 12 months to assess QOL. RESULTS A total of 69 AIS patients were randomized to the demographically similar Ti (n = 37) or CoCr (n = 32) cohort. Four adverse events were recorded, two in each cohort, but these were not related to the rod material. At the final followup, both Ti and CoCr cohorts showed significant improvement in spinal correction, including the Cobb angle, thoracic kyphosis, and rib hump size. The correction rates were 68.4% and 67.1% for the Ti and CoCr cohorts, respectively. No parameters differed significantly between the cohorts at any time. Survey data showed improved but similar outcomes in both cohorts. CONCLUSIONS Both treatments (Ti and CoCr) produced similar results and were efficient in engendering clinically significant spine corrections.
KW - Cobalt-chromium
KW - Deformity
KW - Rod
KW - Scoliosis
KW - Titanium
UR - http://www.scopus.com/inward/record.url?scp=85107217405&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85107217405&partnerID=8YFLogxK
U2 - 10.3171/2020.9.SPINE201486
DO - 10.3171/2020.9.SPINE201486
M3 - Article
C2 - 33740765
AN - SCOPUS:85107217405
VL - 34
SP - 897
EP - 906
JO - Journal of Neurosurgery: Spine
JF - Journal of Neurosurgery: Spine
SN - 1547-5654
IS - 6
ER -