TY - JOUR
T1 - Establishing the minimum clinically important difference in neck disability index and modified japanese orthopaedic association scores for adult cervical deformity
AU - International Spine Study Group
AU - Soroceanu, Alex
AU - Smith, Justin S.
AU - Lau, Darryl
AU - Kelly, Michael P.
AU - Passias, Peter G.
AU - Protopsaltis, Themistocles S.
AU - Gum, Jeffrey L.
AU - Lafage, Virginie
AU - Kim, Han Jo
AU - Scheer, Justin K.
AU - Gupta, Munish
AU - Mundis, Gregory M.
AU - Klineberg, Eric O.
AU - Burton, Douglas
AU - Bess, Shay
AU - Ames, Christopher P.
N1 - Funding Information:
Synthes, Medtronic, Stryker, Medicrea, K2M, and Biomet Zimmer. He receives royalties from Stryker, Biomet Zimmer Spine, DePuy Synthes, NuVasive, Next Orthosurgical, K2M, and Medicrea. He received educational research grants from Titan Spine, DePuy Synthes, and the International Spine Study Group (ISSG). He serves on the editorial board of Operative Neurosurgery. He has received grant funding from the Scoliosis Research Society (SRS), and he is on the executive committee of the ISSG and Global Spinal Analytics. Dr. Bess is a consultant for K2M Stryker and a patent holder with K2M. He received clinical or research support for the study described (includes equipment or material) from the ISSG Foundation, and he also received support of non–study-related clinical or research efforts that he oversaw from the ISSG Foundation. Dr. Burton received clinical or research support for the study described (includes equipment or material) from DePuy and Pfizer. He is a patent holder with DePuy. He has direct stock ownership in Progenerative Medical, and is a consultant for Bioventus. Dr. Gum is an employee of Norton Healthcare. He is a consultant for Medtronic, DePuy, Stryker, Acuity, K2M, PacMed, and NuVasive. He received clinical or research support for the study described (includes equipment or material) from Intellirod, Integra, Pfizer, and the International Spine Study Group. He has direct stock ownership in Cingulate Therapeutics, and he is a patent holder with Medtronic. He receives royalties from Acuity. Dr. Gupta has direct stock ownership in J&J (Johnson & Johnson) and P&G (Procter & Gamble). He is a consultant for Medtronic and DePuy. He receives royalties from Innomed and from DePuy, and he also has acted in an advisory capacity for DePuy. He has received support for travel from Medicrea, Alphatec, SRS, DePuy, AO Spine, and Mizuho. OMeGA and AO Spine paid grants to his institution for fellowships, and AO Spine also paid him an honorarium. Dr. Kelly received support of a non–study-related clinical or research effort that he oversaw from DePuy Synthes. Dr. Klineberg is a consultant for DePuy Synthes, Stryker, and Medicrea. He received a fellowship grant and honoraria from AO Spine. Dr. Lafage is a consultant for Globus Medical and receives royalties from NuVasive. She received honoraria from The Permanente Medical Group and DePuy Synthes. She is on the executive committee of the International Spine Study Group. Dr. Mundis is a consultant for NuVasive, K2M, Viseon, and Seaspine. He has direct stock ownership in NuVasive and Viseon. He receives royalties from NuVasive and K2M. Dr. Passias is a consultant for SpineWave and Medicrea. He is a paid presenter or speaker for Zimmer and Globus Medical. He received clinical or research support for the study described (includes equipment or material) from the Cervical Scoliosis Research Society. He also received support of non–study-related clinical or research efforts that he oversaw from Allosource. Dr. Protopsaltis is a consultant for Globus, Stryker, K2M, NuVasive, Medicrea, and Innovasis. He receives royalties from Altus. Dr. Smith is a consultant for K2M/ Stryker, AlloSource, Cerapedics, Zimmer Biomet, NuVasive, and DePuy Synthes. He received clinical or research support for the study described (includes equipment or material) from DePuy Synthes/ISSG. He also received support of non–study-related clinical or research efforts that he oversaw from DePuy Synthes/ ISSG and AO Spine. Other conflicts include the following: royalties from Zimmer Biomet and NuVasive; fellowship funding from NREF and AO Spine; research support from AO Spine; and stock ownership in Alphatec.
Publisher Copyright:
© AANS 2020, except where prohibited by US copyright law
PY - 2020/10
Y1 - 2020/10
N2 - OBJECTIVE It is being increasingly recognized that adult cervical deformity (ACD) is correlated with significant pain, myelopathy, and disability, and that patients who undergo deformity correction gain significant benefit. However, there are no defined thresholds of minimum clinically important difference (MCID) in Neck Disability Index (NDI) and modified Japanese Orthopaedic Association (mJOA) scores. METHODS Patients of interest were consecutive patients with ACD who underwent cervical deformity correction. ACD was defined as C2-7 sagittal Cobb angle ≥ 10° (kyphosis), C2-7 coronal Cobb angle ≥ 10° (cervical scoliosis), C2-7 sagittal vertical axis ≥ 4 cm, and/or chin-brow vertical angle ≥ 25°. Data were obtained from a consecutive cohort of patients from a multiinstitutional prospective database maintained across 13 sites. Distribution-based MCID, anchor-based MCID, and minimally detectable measurement difference (MDMD) were calculated. RESULTS A total of 73 patients met inclusion criteria and had sufficient 1-year follow-up. In the cohort, 42 patients (57.5%) were female. The mean age at the time of surgery was 62.23 years, and average body mass index was 29.28. The mean preoperative NDI was 46.49 and mJOA was 13.17. There was significant improvement in NDI at 1 year (46.49 vs 37.04; p = 0.0001). There was no significant difference in preoperative and 1-year mJOA (13.17 vs 13.7; p = 0.12). Using multiple techniques to yield MCID thresholds specific to the ACD population, the authors obtained values of 5.42 to 7.48 for the NDI, and 1.00 to 1.39 for the mJOA. The MDMD was 6.4 for the NDI, and 1.8 for the mJOA. Therefore, based on their results, the authors recommend using an MCID threshold of 1.8 for the mJOA, and 7.0 for the NDI in patients with ACD. CONCLUSIONS The ACD-specific MCID thresholds for NDI and mJOA are similar to the reported MCID following surgery for degenerative cervical disease. Additional studies are needed to verify these findings. Nonetheless, the findings here will be useful for future studies evaluating the success of surgery for patients with ACD undergoing deformity correction.
AB - OBJECTIVE It is being increasingly recognized that adult cervical deformity (ACD) is correlated with significant pain, myelopathy, and disability, and that patients who undergo deformity correction gain significant benefit. However, there are no defined thresholds of minimum clinically important difference (MCID) in Neck Disability Index (NDI) and modified Japanese Orthopaedic Association (mJOA) scores. METHODS Patients of interest were consecutive patients with ACD who underwent cervical deformity correction. ACD was defined as C2-7 sagittal Cobb angle ≥ 10° (kyphosis), C2-7 coronal Cobb angle ≥ 10° (cervical scoliosis), C2-7 sagittal vertical axis ≥ 4 cm, and/or chin-brow vertical angle ≥ 25°. Data were obtained from a consecutive cohort of patients from a multiinstitutional prospective database maintained across 13 sites. Distribution-based MCID, anchor-based MCID, and minimally detectable measurement difference (MDMD) were calculated. RESULTS A total of 73 patients met inclusion criteria and had sufficient 1-year follow-up. In the cohort, 42 patients (57.5%) were female. The mean age at the time of surgery was 62.23 years, and average body mass index was 29.28. The mean preoperative NDI was 46.49 and mJOA was 13.17. There was significant improvement in NDI at 1 year (46.49 vs 37.04; p = 0.0001). There was no significant difference in preoperative and 1-year mJOA (13.17 vs 13.7; p = 0.12). Using multiple techniques to yield MCID thresholds specific to the ACD population, the authors obtained values of 5.42 to 7.48 for the NDI, and 1.00 to 1.39 for the mJOA. The MDMD was 6.4 for the NDI, and 1.8 for the mJOA. Therefore, based on their results, the authors recommend using an MCID threshold of 1.8 for the mJOA, and 7.0 for the NDI in patients with ACD. CONCLUSIONS The ACD-specific MCID thresholds for NDI and mJOA are similar to the reported MCID following surgery for degenerative cervical disease. Additional studies are needed to verify these findings. Nonetheless, the findings here will be useful for future studies evaluating the success of surgery for patients with ACD undergoing deformity correction.
KW - Cervical deformity
KW - Minimum clinically importance difference
KW - Modified Japanese Orthopaedic Association
KW - Neck Disability Index
UR - http://www.scopus.com/inward/record.url?scp=85092215691&partnerID=8YFLogxK
U2 - 10.3171/2020.3.SPINE191232
DO - 10.3171/2020.3.SPINE191232
M3 - Article
C2 - 32470935
AN - SCOPUS:85092215691
SN - 1547-5654
VL - 33
SP - 441
EP - 445
JO - Journal of Neurosurgery: Spine
JF - Journal of Neurosurgery: Spine
IS - 4
ER -