Footprint mismatch in total cervical disc arthroplasty

Thaler, Martin; Hartmann, Sébastian; Gstöttner, Michaela; Lechner, Ricarda; Gabl, Michael; Bach, Christian

doi:10.1007/s00586-012-2594-3

Cited by 51 publications

(41 citation statements)

References 24 publications

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“…Thaler et al reported high rates of undersizing of the most commonly used cervical disc implants, including the PRESTIGE LP, and warned of potential consequences, including subsidence, migration, heterotopic ossification, and biomechanical failure caused by incorrect center of rotation and load distribution. 28 As a general rule, patients tend to return to work when their pain has improved to the point that they are able to work. The patient in this study is asked at each followup after surgery if he/she is employed.…”

Section: Discussionmentioning

confidence: 99%

Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study

Gornet

Burkus

Shaffrey

et al. 2015

SPI

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OBJECT This study compared the safety and efficacy of treatment with the PRESTIGE LP cervical disc versus a historical control anterior cervical discectomy and fusion (ACDF). METHODS Prospectively collected PRESTIGE LP data from 20 investigational sites were compared with data from 265 historical control ACDF patients in the initial PRESTIGE Cervical Disc IDE study. The 280 investigational patients with single-level cervical disc disease with radiculopathy and/or myelopathy underwent arthroplasty with a low-profile artificial disc. Key safety/efficacy outcomes included Neck Disability Index (NDI), Neck and Arm Pain Numerical Rating Scale scores, 36-Item Short Form Health Survey (SF-36) score, work status, disc height, range of motion, adverse events (AEs), additional surgeries, and neurological status. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Predefined Bayesian statistical methods with noninformative priors were used, along with the propensity score technique for controlling confounding factors. Analysis by independent statisticians confirmed initial statistical findings. RESULTS The investigational and control groups were mostly similar demographically. There was no significant difference in blood loss (51.0 ml [investigational] vs 57.1 ml [control]) or hospital stay (0.98 days [investigational] vs 0.95 days [control]). The investigational group had a significantly longer operative time (1.49 hours vs 1.38 hours); 95% Bayesian credible interval of the difference was 0.01–0.21 hours. Significant improvements versus preoperative in NDI, neck/arm pain, SF-36, and neurological status were achieved by 1.5 months in both groups and were sustained at 24 months. Patient follow-up at 24 months was 97.1% for the investigational group and 84.0% for the control group. The mean NDI score improvements versus preoperative exceeded 30 points in both groups at 12 and 24 months. SF-36 Mental Component Summary superiority was established (Bayesian probability 0.993). The mean SF-36 PCS scores improved by 14.3 points in the investigational group and by 11.9 points in the control group from baseline to 24 months postoperatively. Neurological success at 24 months was 93.5% in the investigational group and 83.5% in the control group (probability of superiority ~ 1.00). At 24 months, 12.1% of investigational and 15.5% of control patients had an AE classified as device or device/surgical procedure related; 14 (5.0%) investigational and 21 (7.9%) control patients had a second surgery at the index level. The median return-to-work time for the investigational group was 40 days compared with 60 days for the control group (p = 0.020 after adjusting for preoperative work status and propensity score). Following implantation of the PRESTIGE LP device, the mean angular motion was maintained at 12 months (7.9°) and 24 months (7.5°). At 24 months, 90.0% of investigational and 87.7% of control patients were satisfied with the results of surgery. PRESTIGE LP superiority on overall success (without disc height success), a composite safety/efficacy end point, was strongly supported with 0.994 Bayesian probability. CONCLUSIONS This device maintains mean postoperative segmental motion while providing the potential for biomechanical stability. Investigational patients reported significantly improved clinical outcomes compared with baseline, at least noninferior to ACDF, up to 24 months after surgery.

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Section: Discussionmentioning

confidence: 99%

Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study

Gornet

Burkus

Shaffrey

et al. 2015

SPI

View full text Add to dashboard Cite

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“…The design of the available implants is based on anthropometric measurements of the cadavers [ 6 ] and photographs of radiographs [ 7 ]. CT evaluation of bony structures is more accurate, and it has been recently found to be useful in determination of lumbar [ 15 ] and cervical endplates [ 10 ]. Thaler et al [ 10 ] measured the dimensions of cervical vertebrae from computed tomography (CT) scans in 24 patients to assess the accuracy of match achieved with the most common available cervical disc prostheses: Bryan (Medtronic), Prestige-LP (Medtronic), Discover (Depuy), and Prodisc-C (Synthes).…”

Section: Discussionmentioning

confidence: 99%

“…Then the digital measuring tools were used to measure distances after adjusting the axis parallel and perpendicular at each of the endplate on sagittal images, just making sure that there was no obliquity. Four measurements were taken for each endplate as described by Thaler et al [ 10 ]: the AP diameter, the mediolateral diameters at two locations (ML1/2) and the CML diameter as illustrated in Fig. 1 .…”

Section: Methodsmentioning

confidence: 99%

“…A recent study showed that currently available lumbar disc prostheses are much smaller than lumbar endplates regarding anterior-posterior (AP) and central mediolateral (CML) diameter. A study by Thaler et al [ 10 ] has shown considerable mismatch between human values obtained by computed tomography and footprints of C-TDR prostheses available in the market. Study of foot plate geometric features of Indian patients could contribute to design a best fit cervical disc suited for Indians as they contribute to 17% of world population with approximately one Indian in every five individuals worldwide and 32.9% of Asia's population [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

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Cervical Footprint Anthropometry in Indian Population: Implications on Design of Artificial Disc Replacement Devices

et al. 2016

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Study DesignCross-sectional study.PurposeTo accurately measure the dimensions of cervical endplates based on computed tomography (CT) scans in Indian population and assess accuracy of match with currently available cervical disc prostheses.Overview of LiteratureThe dimensions of currently available cervical disc replacement implants are based on early published geometrical measurements of vertebrae endplates for Caucasian population. To author's knowledge, similar study has not been published for patients from Indian subcontinent.MethodsCT scans of cervical spine of patients from Indian subcontinent were collected and reviewed. Seventy patients (54 men and 16 women; aged 18–56 years with average of 37 years) who underwent CT scans of cervical spine were included in study. 3D CT scans of sub axial cervical spine (C3 to C7) were analyzed. The anterior-posterior (AP) and central mediolateral (CML) dimensions of superior and inferior endplates from C3 to C7 were measured using digital measuring system.ResultsA total of 560 endplates of 70 patients were included in the study. The AP diameter of cervical endplates ranged from 0.87 to 2.47 cm. The CML diameters ranged from 0.84 to 2.98 cm. For levels C3/C4 and C4/C5 for AP dimension Prestige-LP (90.5%) and Prodisc-C (89%) discs showed higher percentage of matching than Discover discs (58.5%). For CML diameter, Prestige-LP (69.5%), Prodisc-C (70%) and Discover (39.5%) discs showed almost similar matching with measured endplates. For levels C5/C6 and C6/C7 for AP dimension, Prestige-LP (67.25%), Prodisc-C (49.35%) and Discover (51.5%) discs showed similar matching. For CML diameter Prestige-LP (32%), Prodisc-C (27.5%) and Discover (42.2%) discs showed poor matching with measured endplates.ConclusionsThis study indicates need for redesign of cervical disc prostheses to match Indian patients. The collected anthropometric dimensions from this study may be used to design and develop indigenous artificial total disc replacement prosthesis and even cervical cages in India. With the present study being a small pilot study, the authors recommend anthropometric CT measurements in larger number of Indian patients in order to validate footprint dimensions for designing better-matched prosthesis.

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“…The negative effect of imperfect device positioning and endplate-device matching would likely be amplified in multilevel CDA. 19,20 The incidence of heterotopic ossification (HO) has been found to increase with the number of cervical arthroplasty levels without affecting patient-reported outcomes. 21,22 Further and stronger long-term evidence is still needed in order to evaluate multilevel cervical surgeries.…”

Section: Introductionmentioning

confidence: 99%

One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years

Gornet

Lanman

Burkus³

et al. 2019

Int J Spine Surg

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Background: Anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) have been used to treat degenerative disc disease at single as well as multiple cervical levels. This study compares the safety and efficacy of 1-level versus 2-level CDA and ACDF. Methods: In total, 545 and 397 patients with degenerative disc disease were studied in 1-level and 2-level Food and Drug Administration (FDA)-approved clinical trials, respectively: CDA (n ¼ 280 and 209), ACDF (n ¼ 265 and 188). Data from these studies were used to compare 1-versus 2-level procedures: the propensity score method was used to adjust for potential confounding effects, and adjusted mean outcome safety and efficacy scores at 2 and 7 years postsurgery were compared between 1-level and 2-level procedures within treatment type. Results: One-level and 2-level procedures had similar rates of improvement in overall success and patient-reported outcomes scores for both CDA and ACDF. There were no statistical differences in rates of implant-related adverse events (AEs) or serious implant-related AEs between 1-level and 2-level CDA. The 7-year rate of implant-related AEs was higher for 2-level than 1-level ACDF (27.7% vs 18.9%, P .036), though the rates of serious implant-related AEs between ACDF groups did not differ significantly. Secondary surgery rates were not statistically different between 1level and 2-level procedures (CDA or ACDF) at the index or adjacent levels at 2 or 7 years. Grade IV heterotopic ossification at 7 years was reported in 4.6% of 1-level CDA patients and 8.6%/7.3% at the superior/inferior levels, respectively, of 2-level CDA patients. Conclusions: One-and 2-level CDA appear equally safe and effective in the treatment of cervical degenerative disc disease. Two-level ACDF appears to be as effective as 1-level ACDF but with a higher rate of some AEs at longterm follow-up.

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Footprint mismatch in total cervical disc arthroplasty

Cited by 51 publications

References 24 publications

Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study

Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study

Cervical Footprint Anthropometry in Indian Population: Implications on Design of Artificial Disc Replacement Devices

One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years

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