112. Changes in flexion/extension range of motion due to oversizing of cervical total disc arthroplasty

Kim, Kee D.; Karnati, Tejas; Permeswaran, Vijay N.; Gandhi, Anup

doi:10.1016/j.spinee.2019.05.125

Cited by 3 publications

(6 citation statements)

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“…5 Another biomechanical study found that increasing the TDR implant size by 1 mm significantly reduced ROM. 17 Other investigators reported similar findings in their biomechanical study that increasing the implant height beyond 1 mm greater than the native disk height resulted in decreased ROM of the TDR index level. 18 These authors further noted that implantation of a taller implant did not result in significantly greater foraminal size.…”

Section: Discussionsupporting

confidence: 53%

“…It was reported that TDRs with a height exceeding the natural disk height by 2 mm or more may lead to marked changes in the cervical biomechanics and bone-implant interface stress 5. Another biomechanical study found that increasing the TDR implant size by 1 mm significantly reduced ROM 17. Other investigators reported similar findings in their biomechanical study that increasing the implant height beyond 1 mm greater than the native disk height resulted in decreased ROM of the TDR index level 18.…”

Section: Discussionmentioning

confidence: 84%

“…[10][11][12] This may be related to the biomechanical studies finding that implanting a TDR that is greater that natural height reduces ROM of the operated segment. 17,18 The reduced motion may allow greater one growth around the prosthesis. In contrast, a clinical study reported that taller implants were related to greater ROM and a greater occurrence of HO.…”

Section: Discussionmentioning

confidence: 99%

“…Several biomechanical studies involving cervical TDR have investigated the potential impact of prosthesis height, particularly with respect to implant sizes larger than the natural height. These studies found that increased implant height was associated with decreased range of motion (ROM), [4][5][6][7] reduced facet overlap, possibly altering the loading of the adjacent facet joints which may impact the motion of the index level as well as loading of the adjacent segments, 4,5,8,9 and also related to the development of heterotopic ossification (HO). [10][11][12] With respect to implant height, one study found that in 36% of a study population, the height of the cervical disk space was less than the minimal height of available TDRs, which is generally 5 mm.…”

mentioning

confidence: 99%

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Cervical Total Disk Replacement

Guyer

Coric

Nunley

et al. 2022

Clinical Spine Surgery: A Spine Publication

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Study Design: This study was a post hoc analysis of data collected from 2 Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trials. Objective: The purposes of this study were to: (1) measure disk space heights adjacent to the level to be treated with a total disk replacement (TDR); (2) analyze cervical disk space heights to be replaced with TDR; and (3) investigate the frequency of use of a smaller height TDR when available. Summary of Background Data: Cervical TDR produces outcomes noninferior or superior to anterior cervical discectomy and fusion. While the restoration of the height of a collapsed, degenerated disk is a surgical goal, there are potential problems with overdistracting the segment with an implant. Methods: Disk heights were measured using radiographs from the 1-level Simplify Cervical Artificial Disk IDE trial, producing values for 259 levels adjacent to the treated level and 162 treated levels. The device is available in 4, 5, and 6 mm heights. The 4 mm height became available only after treatment was 13% complete in the single-level trial and was available for all of the 2-level trial. Results: Measurements of 259 adjacent levels found that 55.2% of disk spaces had a height of <4 mm. Among operated levels, 82.7% were <4 mm. When a 4 mm TDR was available, it was used in 38.4% of operated levels in the 1-level trial and 54.3% of levels in the 2-level trial. Conclusions: Among nonoperated levels, 55.2% were of height <4 mm, suggesting that TDRs of greater heights may potentially overdistract the disk space. The 4 mm TDR was selected by surgeons in 49.4% of all implanted levels, suggesting a preference for smaller TDR height. Further investigation is warranted to determine if the lower height implants are related to clinical and/or radiographic outcomes. Level of Evidence: Level III.

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Section: Discussionsupporting

confidence: 53%

Section: Discussionmentioning

confidence: 84%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Cervical Total Disk Replacement

Guyer

Coric

Nunley

et al. 2022

Clinical Spine Surgery: A Spine Publication

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“…27,30 Several biomechanical studies involving cervical TDR have investigated the potential impact of prosthesis height, particularly with respect to implant sizes that are larger than the natural disc space height. These studies found that increased implant height was associated with decreased ROM [31][32][33] and reduced facet overlap, possibly altering the loading of the adjacent facet joints. These changes could affect the motion of the index level as well as loading of the adjacent segments 31,32,34,35 and could also be related to the development of HO.…”

Section: Discussionmentioning

confidence: 97%

Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up

et al. 2021

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Background: Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. Polyetheretherketone (PEEK) is used increasingly for spinal implants due to its mechanical properties and lack of artifacts on imaging. A TDR was designed with titanium-coated PEEK endplates and a ceramic core. The purpose of this study was to compare this TDR with anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration.Methods: This was a prospective, nonrandomized, historically controlled, multicenter US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial. Patients received the PEEK-on-ceramic Simplify t Cervical Artificial Disc (n ¼ 150). The historic control group included 117 propensity-matched ACDF patients from an earlier IDE trial. The primary outcome was a composite success classification at the 24-month follow-up. Outcome measures included the Neck Disability Index (NDI), neurological status, adverse events, subsequent surgery, a visual analog scale assessing neck and arm pain, and the Dysphagia Handicap Index. Radiographic assessment included flexion/extension range of motion and heterotopic ossification. Facet joints were assessed at 24 months using MRI.Results: The success rate was significantly greater in the TDR group vs the ACDF group (93.0% vs 73.6%; P , .001). Mean NDI, neck pain, and arm pain scores improved significantly in both groups at all follow-up points. Mean NDI scores in the TDR group were significantly lower than ACDF scores at all follow-up points. There were no significant differences in the rates of serious adverse events. The range of motion of the TDR level had increased significantly by 3 months and remained so throughout follow-up. Facet joint assessment by MRI in the TDR group showed little change from preoperation.Conclusions: The TDR had an acceptable safety profile and a significantly greater composite success rate than ACDF. These results support that the PEEK-on-ceramic TDR is a viable alternative to ACDF for single-level symptomatic disc degeneration.Clinical Relevance: This study found that the PEEK-on-ceramic TDR is a viable treatment for symptoms related to cervical disc degeneration and offers similar or superior outcomes compared with fusion.

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Optimal Implant Sizing Using Machine Learning Is Associated With Increased Range of Motion After Cervical Disk Arthroplasty

Lakomkin,

Pennington,

Bhandarkar

et al. 2024

Neurosurgery

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BACKGROUND AND OBJECTIVES: Cervical disk arthroplasty (CDA) offers the advantage of motion preservation in the treatment of focal cervical pathology. At present, implant sizing is performed using subjective tactile feedback and imaging of trial cages. This study aims to construct interpretable machine learning (IML) models to accurately predict postoperative range of motion (ROM) and identify the optimal implant sizes that maximize ROM in patients undergoing CDA. METHODS: Adult patients who underwent CDA for single-level disease from 2012 to 2020 were identified. Patient demographics, comorbidities, and outcomes were collected, including symptoms, examination findings, subsidence, and reoperation. Affected disk height, healthy rostral disk height, and implant height were collected at sequential time points. Linear regression and IML models, including bagged regression tree, bagged multivariate adaptive regression spline, and k-nearest neighbors, were used to predict ROM change. Model performance was assessed by calculating the root mean square error (RMSE) between predicted and actual changes in ROM in the validation cohort. Variable importance was assessed using RMSE loss. Area under the curve analyses were performed to identify the ideal implant size cutoffs in predicting improved ROM. RESULTS: Forty-seven patients were included. The average RMSE between predicted and actual ROM was 7.6° (range: 5.8-10.1) in the k-nearest neighbors model, 7.8° (range: 6.5-10.0) in the bagged regression tree model, 7.8° (range: 6.2-10.0) in the bagged multivariate adaptive regression spline model, and 15.8° (range: 14.3-17.5°) in a linear regression model. In the highest-performing IML model, graft size was the most important predictor with RMSE loss of 6.2, followed by age (RMSE loss = 5.9) and preoperative caudal disk height (RMSE loss = 5.8). Implant size at 110% of the normal adjacent disk height was the optimal cutoff associated with improved ROM. CONCLUSION: IML models can reliably predict change in ROM after CDA within an average of 7.6 degrees of error. Implants sized comparably with the healthy adjacent disk may maximize ROM.

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112. Changes in flexion/extension range of motion due to oversizing of cervical total disc arthroplasty

Cited by 3 publications

References 0 publications

Cervical Total Disk Replacement

Cervical Total Disk Replacement

Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up

Optimal Implant Sizing Using Machine Learning Is Associated With Increased Range of Motion After Cervical Disk Arthroplasty

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