Four-year results of a prospective single-arm study on 200 semi-constrained total cervical disc prostheses: clinical and radiographic outcome

Meisel, Hans Jörg; Jurák, Lubomír; Antinheimo, Jussi; Arregui, Ricardo; Bruchmann, Bernhard; Čabraja, Mario; Caroli, Fabrizio; Kroppenstedt, Stefan; Kryl, J; Pohjola, Juha; Shackleford, Ian; Sola, Steffen; Stosberg, Peter; Štulík, J; Woiciechowsky, Christian; Suchomel, Petr

doi:10.3171/2016.3.spine15810

Cited by 32 publications

(18 citation statements)

References 63 publications

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“…Grades of HO using the original McAfee scale include a broad range: grade 0, 12.0%-92.3%; grade 1, 0%-37.4%; grade 2, 2.6%-35.5%; grade 3, 0%-45.0%; grade 4, 0.4%-22.2%. [20][21][22] A review by Kang et al 23 included a pooled incidence across multiple studies of 27.7% grade 3 and 7.8% grade 4 HO.…”

Section: Discussionmentioning

confidence: 99%

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Heterotopic Ossification After Cervical Total Disc Replacement at 7 Years—Prevalence, Progression, Clinical Implications, and Risk Factors

et al. 2018

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Background: Heterotopic ossification (HO) is a known risk following cervical total disc replacement (CTDR) surgery, but the cause and effect of HO are not well understood. Reported HO rates vary, and few studies are specifically designed to report HO. The effects on outcomes, and the risk factors for the development of HO have been hypothesized and reported in small-population, retrospective analyses, using univariate statistics.Methods: Posthoc, multiple-phase analysis of radiographic, clinical, and demographic data for CTDR as it relates to HO was performed. HO was radiographically graded for 164 one-level and 225 two-level CTDR patients using the McAfee and Mehren system. Analysis was performed to correlate HO grades to clinical outcomes and to evaluate potential risk factors for the development of HO using demographics and baseline clinical measures.Results: At 7 years, 1-level clinically relevant HO grades were 17.6% grade 3 and 11.1% grade 4. Two-level clinically relevant HO grades, evaluated using the highest patient grade, were 26.6% grade 3 and 10.8% grade 4. Interaction between HO and time revealed significance for neck disability index (NDI; P ¼ .04) and Visual Analog Scale (VAS) neck pain (P ¼ .02). When analyzed at each time point NDI was significant at 48-84 months and VAS neck at 60 months. For predictors 2 analyses were run; odds ratios indicated follow-up visit, male sex, and preoperative VAS neck pain are related to HO development, whereas hazard ratios indicated male sex, obesity, endplate coverage, levels treated, and preoperative VAS neck pain.Conclusions: This is the largest study to report HO rates, and related outcomes and risk factors. To develop an accurate predictive model, further large-scale analyses need to be performed. Based on the results reported here, clinically relevant HO should be more accurately described as motion-restricting HO until a definitive link to outcomes has been established.

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Section: Discussionmentioning

confidence: 99%

“…[16][17][18][19] Reported rates of HO following CTDR vary drastically, creating more debate and concern around the true rate and impact of HO. [20][21][22][23] The long-term effects of HO resulting in unintended fusion have not been analyzed.…”

Section: Introductionmentioning

confidence: 99%

Heterotopic Ossification After Cervical Total Disc Replacement at 7 Years—Prevalence, Progression, Clinical Implications, and Risk Factors

et al. 2018

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“…However, we experienced complications related to cervical arthroplasty such as postoperative segmental kyphosis, heterotopic ossification, osteolysis, dislocation of the prosthesis, bone-implant failure, and pullout of the artificial disc. 3,11,12,14,21 Theoretically, cervical arthroplasty can preserve the motion of the surgically treated segment in contrast to cervical fusion surgeries. 3,15,24 However, heterotopic ossification occurred in patients who underwent cervical TDR, and its effect interferes with motion preservation of the operative segments.…”

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confidence: 99%

Bone loss of vertebral bodies at the operative segment after cervical arthroplasty: a potential complication?

Heo

Lee

et al. 2017

FOC

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OBJECTIVE Bony overgrowth and spontaneous fusion are complications of cervical arthroplasty. In contrast, bone loss or bone remodeling of vertebral bodies at the operation segment after cervical arthroplasty has also been observed. The purpose of this study is to investigate a potential complication—bone loss of the anterior portion of the vertebral bodies at the surgically treated segment after cervical total disc replacement (TDR)—and discuss the clinical significance. METHODS All enrolled patients underwent follow-up for more than 24 months after cervical arthroplasty using the Baguera C disc. Clinical evaluations included recording demographic data and measuring the visual analog scale and Neck Disability Index scores. Radiographic evaluations included measurements of the functional spinal unit's range of motion and changes such as bone loss and bone remodeling. The grading of the bone loss of the operative segment was classified as follows: Grade 1, disappearance of the anterior osteophyte or small minor bone loss; Grade 2, bone loss of the anterior portion of the vertebral bodies at the operation segment without exposure of the artificial disc; or Grade 3, significant bone loss with exposure of the anterior portion of the artificial disc. RESULTS Forty-eight patients were enrolled in this study. Among them, bone loss developed in 29 patients (Grade 1 in 15 patients, Grade 2 in 6 patients, and Grade 3 in 8 patients). Grade 3 bone loss was significantly associated with postoperative neck pain (p < 0.05). Bone loss was related to the motion preservation effect of the operative segment after cervical arthroplasty in contrast to heterotopic ossification. CONCLUSIONS Bone loss may be a potential complication of cervical TDR and affect early postoperative neck pain. However, it did not affect mid- to long-term clinical outcomes or prosthetic failure at the last follow-up. Also, this phenomenon may result in the motion preservation effect in the operative segment after cervical TDR.

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“…These trials suggest that preoperative segmental ROM should range between 2° to 11° or 20° on lateral flexion-extension X-rays [4][5][6][7][8][9], presenting patients who have undergone CDA with a wide range of variability in segmental motion. There are no clear guidelines as to the optimal preoperative index-level ROM that could be considered amenable to CDA in any given trials; although the preoperative ROM at the index level averaged 7°-9°, and was successfully preserved the similar motion after surgery [10][11][12][13][14]. These observations raise a question for surgeons: whether limited or excessive preoperative ROM, other than the average one at the index level, could also achieve satisfactory clinical or kinematic outcomes.…”

Section: Introductionmentioning

confidence: 99%

Effect of preoperative segmental range of motion on patient outcomes in cervical disc arthroplasty

Líu

Ding

et al. 2020

Preprint

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BackgroundCervical disc arthroplasty (CDA) has been demonstrated in clinical trials as an effective and safe treatment for patients diagnosed with radiculopathy and/or myelopathy. However, the current CDA indication criteria based on the preoperative segmental range of motion (ROM), comprise a wide range of variability. Although the arthroplasty level preserved ROM averaged 7°-9° after CDA, there are no clear guidelines on preoperatively limited or excessive ROM at the index level, that could be considered as suitable for CDA in any given trials.MethodsPatients who underwent CDA between January 2008 to October 2018 using Prestige-LP discs in our hospital, were reviewed retrospectively. They were divided into the small-ROM (≤5.5°) and the large-ROM (> 12.5°) groups according to preoperatively index-level ROM. Clinical outcomes, including the Japanese Orthopedics Association (JOA), Neck Disability Index (NDI), and Visual Analogue Scale (VAS) scores, were evaluated. Radiological parameters, including cervical lordosis, disc angle (DA), global and segmental ROM, disc height (DH), and complications were measured.ResultsOne hundred and twenty-six patients, with a total of 132 arthroplasty segments were analyzed. There were 64 patients in the small-ROM and 62 in the large-ROM group. There are more patients diagnosed with cervical spondylosis in the small-ROM than in the large-ROM group (P=0.046). Patients in both groups had significantly improved in JOA, NDI, and VAS scores after surgery, but the intergroup difference was not significant. Patients in the small-ROM group increased dramatically in cervical lordosis, global and segmental ROM postoperatively (P < 0.001). However, global and segmental ROM paradoxically decreased in the large-ROM group postoperatively (P < 0.001). Patients in the small-ROM group had lower DH preoperatively (P=0.012), and a higher rate of heterotopic ossification (HO) postoperatively (P=0.037).ConclusionPatients with preoperatively limited or excessive segmental ROM could achieve satisfactory clinical outcomes at 3 years postoperatively. Patients with limited segmental ROM had more, and severe HO and significantly increased segmental mobility, which decreased in patients with excessive segmental ROM after surgery.

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Four-year results of a prospective single-arm study on 200 semi-constrained total cervical disc prostheses: clinical and radiographic outcome

Cited by 32 publications

References 63 publications

Heterotopic Ossification After Cervical Total Disc Replacement at 7 Years—Prevalence, Progression, Clinical Implications, and Risk Factors

Heterotopic Ossification After Cervical Total Disc Replacement at 7 Years—Prevalence, Progression, Clinical Implications, and Risk Factors

Bone loss of vertebral bodies at the operative segment after cervical arthroplasty: a potential complication?

Effect of preoperative segmental range of motion on patient outcomes in cervical disc arthroplasty

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