Five-year results of cervical disc prostheses in the SWISSspine registry

Aghayev, Emin; Bärlocher, Christian B.; Sgier, F; Hasdemir, Mustafa; Steinsiepe, Klaus F.; Wernli, F.; Porchet, François; Hausmann, Oliver; Ramadan, A.; Maestretti, Gianluca; Ebeling, U.; Neukamp, Michal; Röder, Christoph

doi:10.1007/s00586-013-2770-0

Cited by 21 publications

(16 citation statements)

References 38 publications

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“…These findings are similar to those reported for other cervical TDR devices throughout a 5-year follow-up. 1,12,31 Continued motion of the TDR throughout the 5-year follow-up is supported by the finding that the mean ROM value was greater than the preoperative value. The percentage of patients with HO increased over time.…”

Section: Discussionmentioning

confidence: 76%

“…Total disc replacement outcomes similar to those of the FDA-regulated trials have been reported from other countries as well. 1,26,27,30 There have been no prospective randomized reports of a cobalt-chromium MoM cervical TDR device with a long-term follow-up. The MoM devices have been the least studied and, because of problems associated with MoM hip prostheses, 5,17 the most controversial.…”

mentioning

confidence: 99%

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Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc

Coric

Guyer

Nunley

et al. 2018

Journal of Neurosurgery: Spine

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OBJECTIVESeven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up.METHODSAn FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR.RESULTSA total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring.CONCLUSIONSCervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy.Clinical trial registration no.: NCT00374413 (clinicaltrials.gov)

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Section: Discussionmentioning

confidence: 76%

mentioning

confidence: 99%

Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc

Coric

Guyer

Nunley

et al. 2018

Journal of Neurosurgery: Spine

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“…The same applies to device failure and secondary surgeries at the index level. 1,11,13,17,22,47,52,59 Cervical and segmental lordosis improved versus the preoperative situation, ROM decreased from 9.3° to 6.5° at 4-year-follow-up, and in 82.4% of patients a segmental motion of at least 2° was maintained. A similar tendency was reported by Goffin et al 22 on the Bryan disc with an ROM reduction from 9.3° preoperatively to 7.3° 4 years postoperatively and a motion ≥ 2° in 83.1% of single-level procedures, whereas Sasso et al 47 did not report a rate of motion maintenance in their extended investigational device exemption trial on the Bryan disc, but observed an improvement of ROM from 6.5° preoperatively to 8.5° 4 years postoperatively.…”

Section: Discussionmentioning

confidence: 77%

“…19,46 Today, several devices for cTDR with different design concepts are on the market, some of them with clinical and radiographic mid-to long-term results. 1,11,13,17,22,41,47,52,57,59 Various randomized controlled trials have indicated equivalence or even superiority of cTDR in some clinical aspects compared with ACDF. 9,25,36,40,54 However, there remains critical debate on cTDR mainly regarding indication, costs, and heterotopic ossification (HO).…”

mentioning

confidence: 98%

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

Meisel

Jurák

Antinheimo

et al. 2016

SPI

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OBJECTIVE Recent studies have described encouraging outcomes after cervical total disc replacement (cTDR), but there are also critical debates regarding the long-term effects of heterotopic ossification (HO) and the prevalence of adjacent-level degeneration. The aim in this paper was to provide 4-year clinical and radiographic outcome results on the activ C disc prosthesis. METHODS A total of 200 subjects underwent single-level activ C (Aesculap AG) implantation between C-3 and C-7 for the treatment of symptomatic degenerative disc disease. Clinical and radiographic assessments were performed preoperatively, intraoperatively, at discharge, and again at 6 weeks, 6 months, 1 year, 2 years, and 4 years. Radiographic evaluations were done by an independent core laboratory using a specific software for quantitative motion analysis. RESULTS Neck Disability Index (NDI) and visual analog scale (VAS) score for neck and arm pain decreased significantly from baseline to the 4-year follow-up. The mean improvement for NDI was 20, for VAS severity and frequency of neck pain 26.4 and 28, and for VAS severity and frequency of arm pain 30.7 and 35.1, respectively. The neurological situation improved for the majority of patients (86.4%); 76.1% of cases were asymptomatic. Subsequent surgical interventions were reported in 7% of the cases, including device removals in 3%. In 2.5% a subsidence greater than 3 mm was recorded; 1 of these cases also had a migration greater than 3 mm. No device displacement, expulsion, disassembly, loose or fractured device, osteolysis, or facet joint degeneration at the index level was observed. Segmental lordotic alignment changed from −2.4° preoperatively to −6.2° at 4 years, and postoperative height was maintained during the follow-up. Advanced HO (Grade III and IV) was present in 27.1% of the cases; 82.4% showed segmental mobility. A progression of radiographic adjacent-segment degeneration occurred in 28.2%, but only 4.5% required surgical treatment. CONCLUSIONS The activ C is a safe and effective device for cervical disc replacement confirming the encouraging results after cTDR. Clinical trial registration no.: NCT02492724 (clinicaltrials.gov)

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“…There are a few studies with extended follow-up to five or more years. [9][10][11][12] Results of these long-term studies have been consistent in that the favorable outcomes seen at 2 years after surgery were maintained throughout the longer follow-up.…”

Section: Introductionmentioning

confidence: 80%

Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up

et al. 2016

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IntroductionThere is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up.

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Five-year results of cervical disc prostheses in the SWISSspine registry

Cited by 21 publications

References 38 publications

Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc

Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc

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

Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up

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