TY - JOUR
T1 - Radiographic predictors of instability vs composite clinical success of spondyloplasty of TLIF for degenerative spondylolisthesis. Analysis of results from a prospective FDA IDE trial
AU - Alamin, Todd F.
AU - Castro, Javier
AU - Sasso, Rick C.
AU - Bae, Hyun W.
AU - Villavicencio, Alan T.
AU - Gum, Jeffrey L.
AU - Perez-Cruet, Mick J.
AU - Yoon, S. Tim
AU - Lavelle, William F.
AU - Kim, Kee D.
AU - Wang, Michael Y.
AU - Fielding, Louie C.
AU - Guyer, Richard D.
AU - Yu, Elizabeth
AU - White, Andrew P.
AU - Deutsch, Harel
AU - Ray, Wilson Z.
AU - Fischgrund, Jeffrey S.
AU - Shimer, Adam L.
AU - Kuo, Calvin C.
AU - Stauff, Michael
N1 - Publisher Copyright:
© 2024
PY - 2024/9
Y1 - 2024/9
N2 - BACKGROUND CONTEXT: Blumenthal et al (2013) found that segmental facet joint angle (FJA) >50°, disc height (DH) >6.5mm and segmental translation (ST) >1.25mm were associated with higher rates of reoperation in patients who had decompression only, without fusion, for symptomatic degenerative spondylolisthesis (DS). An ongoing FDA IDE study (NCT03115983) is comparing spondyloplasty (decompression and dynamic sagittal tether (DST) stabilization vs decompression and transforaminal lumbar interbody fusion (TLIF) for symptomatic DS. Radiographic measures including those identified by Blumenthal may identify signals among subgroups with clinical success or failure. PURPOSE: The purpose of this analysis is to assess composite clinical success (CCS) among spondyloplasty and TLIF subjects having a PDI. STUDY DESIGN/SETTING: Post-hoc analysis of data from a multi-center, prospective IDE study of spondyloplasty vs TLIF for symptomatic DS (NCT03115983). PATIENT SAMPLE: A total of 299 subjects enrolled in the IDE trial of spondyloplasty (N=140) vs TLIF (N=159). Full study inclusion criteria provided at clinicaltrials.gov (NCT03115983). OUTCOME MEASURES: Primary outcome measure CCS was defined as patients meeting all of the following through 24-months: successful index implantation; 15-point improvement on the Oswestry Disability Index (ODI); no device integrity failure defined as device breakage, separation, dislocation or disassembly; no subsequent surgical intervention (SSI) at the index or adjacent segments; and no decrease in neurologic status unless attributable to a concurrent medical condition or other unrelated cause. PDI were defined as ST>1.25mm, FJA>50° or DH>6.5mm as measured on preoperative radiographs. METHODS: CCS rates were calculated for each subgroup of patients having or not having each individual PDI, all PDI, any PDI or no PDI in each of the two treatment arms. Influence of each PDI was assessed using student's t-test to compare subjects with and without the PDI. RESULTS: Too Long Text characters = 69300 max allowed in xls 32,250. CONCLUSIONS: There was no identifiable relationship between any of the preoperative radiographic parameters and clinical success in either the spondyloplasty or TLIF groups. Notably, failures in the spondyloplasty group were not associated with higher preoperative mobility, disc height, anterolisthesis or FJ angle, as has been seen in decompression alone.
AB - BACKGROUND CONTEXT: Blumenthal et al (2013) found that segmental facet joint angle (FJA) >50°, disc height (DH) >6.5mm and segmental translation (ST) >1.25mm were associated with higher rates of reoperation in patients who had decompression only, without fusion, for symptomatic degenerative spondylolisthesis (DS). An ongoing FDA IDE study (NCT03115983) is comparing spondyloplasty (decompression and dynamic sagittal tether (DST) stabilization vs decompression and transforaminal lumbar interbody fusion (TLIF) for symptomatic DS. Radiographic measures including those identified by Blumenthal may identify signals among subgroups with clinical success or failure. PURPOSE: The purpose of this analysis is to assess composite clinical success (CCS) among spondyloplasty and TLIF subjects having a PDI. STUDY DESIGN/SETTING: Post-hoc analysis of data from a multi-center, prospective IDE study of spondyloplasty vs TLIF for symptomatic DS (NCT03115983). PATIENT SAMPLE: A total of 299 subjects enrolled in the IDE trial of spondyloplasty (N=140) vs TLIF (N=159). Full study inclusion criteria provided at clinicaltrials.gov (NCT03115983). OUTCOME MEASURES: Primary outcome measure CCS was defined as patients meeting all of the following through 24-months: successful index implantation; 15-point improvement on the Oswestry Disability Index (ODI); no device integrity failure defined as device breakage, separation, dislocation or disassembly; no subsequent surgical intervention (SSI) at the index or adjacent segments; and no decrease in neurologic status unless attributable to a concurrent medical condition or other unrelated cause. PDI were defined as ST>1.25mm, FJA>50° or DH>6.5mm as measured on preoperative radiographs. METHODS: CCS rates were calculated for each subgroup of patients having or not having each individual PDI, all PDI, any PDI or no PDI in each of the two treatment arms. Influence of each PDI was assessed using student's t-test to compare subjects with and without the PDI. RESULTS: Too Long Text characters = 69300 max allowed in xls 32,250. CONCLUSIONS: There was no identifiable relationship between any of the preoperative radiographic parameters and clinical success in either the spondyloplasty or TLIF groups. Notably, failures in the spondyloplasty group were not associated with higher preoperative mobility, disc height, anterolisthesis or FJ angle, as has been seen in decompression alone.
UR - http://www.scopus.com/inward/record.url?scp=85201405279&partnerID=8YFLogxK
U2 - 10.1016/j.spinee.2024.06.408
DO - 10.1016/j.spinee.2024.06.408
M3 - Conference article
AN - SCOPUS:85201405279
SN - 1529-9430
VL - 24
SP - S203-S204
JO - Spine Journal
JF - Spine Journal
IS - 9
T2 - NASS 39th Annual Meeting
Y2 - 25 September 2024 through 28 September 2024
ER -