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

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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Radiographic Outcome and Adjacent Segment Evaluation Two Years after Cervical Disc Replacement with the Baguera®C Prosthesis as Treatment of Degenerative Cervical Disc Disease

Journal of Spine ◽

10.4172/2165-7939.1000298 ◽

2016 ◽

Vol 05 (02) ◽

Cited By ~ 4

Author(s):

Patrick Fransen ◽

Nils Hansen-Algenstaedt

Keyword(s):

Disc Replacement ◽

Cervical Disc ◽

Adjacent Segment ◽

Radiographic Outcome ◽

Cervical Disc Disease ◽

Disc Disease ◽

Cervical Disc Replacement ◽

Degenerative Cervical Disc Disease

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Early results after ProDisc-C cervical disc replacement

Journal of Neurosurgery Spine ◽

10.3171/spi.2005.2.4.0403 ◽

2005 ◽

Vol 2 (4) ◽

pp. 403-410 ◽

Cited By ~ 106

Author(s):

Rudolf Bertagnoli ◽

James J. Yue ◽

Frank Pfeiffer ◽

Andrea Fenk-Mayer ◽

James P. Lawrence ◽

...

Keyword(s):

Cervical Spondylosis ◽

Total Disc Replacement ◽

Disc Replacement ◽

Definitive Treatment ◽

Cervical Disc ◽

Content Type ◽

Cervical Disc Replacement ◽

Arm Pain ◽

Early Results ◽

Fine Print

Object. Cervical anterior decompression and total-disc replacement is currently being investigated as an alternative treatment in patients with symptomatic intervertebral cervical spondylosis with and without radiculopathy. The authors prospectively investigated the safety and efficacy of using the ProDisc-C disc for cervical arthroplasty in the treatment of symptomatic cervical spondylosis. Methods. Sixteen patients in whom a diagnosis of symptomatic cervical spondylosis had been established were prospectively treated with complete anterior cervical discectomy and ProDisc-C cervical disc arthroplasty. Overall 12 single- and four two-level procedures were performed (20 prostheses). Patients underwent pre- and multiple postoperative assessments (3 and 6 weeks and 3, 6, and 12 months). The median age of all patients was 50 years (range 32–60 years). Levels of surgery included seven C5–6, six C6–7, and three C4–5. Neck and arm pain as well as disability scores were significantly improved by 3 months and remained significantly improved at 1 year. No additional fusion surgeries were necessary at the affected or unaffected levels. Radiography revealed an affected disc motion from 4 to 12°. No surgery- or device-related complications were documented. Conclusions. Analysis of preliminary results involving ProDisc-C arthroplasty indicates significant improvement in pain and functional outcome scores. No spontaneous fusions at the level of surgery or at adjacent levels were noted. Long-term follow-up studies will be necessary before more definitive treatment recommendations can be formulated.

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Clinical results and development of heterotopic ossification in total cervical disc replacement during a 4-year follow-up. Suchomel P, Jurák L, Benes V 3rd, et al. Eur Spine J 2010;19(2):307–15. Epub 2009 Dec 25

The Spine Journal ◽

10.1016/j.spinee.2010.06.033 ◽

2010 ◽

Vol 10 (9) ◽

pp. 843

Keyword(s):

Heterotopic Ossification ◽

Clinical Results ◽

Disc Replacement ◽

Cervical Disc ◽

Cervical Disc Replacement

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Cervical sagittal alignment after Prestige LP cervical disc replacement: radiological results and clinical impacts from a single-center experience

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-03962-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xiaofei Wang ◽

Yang Meng ◽

Hao Liu ◽

Hua Chen ◽

Beiyu Wang ◽

...

Keyword(s):

Sagittal Alignment ◽

Disc Replacement ◽

Cervical Disc ◽

Adjacent Segment ◽

Single Center ◽

Disc Disease ◽

Sagittal Vertical Axis ◽

Cervical Disc Replacement ◽

Cervical Sagittal Alignment ◽

The Impact

Abstract Background Cervical disc replacement (CDR) has been widely used to treat one- and two-level cervical degenerative disc disease. Studies have shown the effectiveness of CDR in preserving range of motion (ROM) and delaying adjacent segment degeneration (ASD). Cervical sagittal alignment is an important factor affecting favorable clinical outcomes in cervical spine surgery. This study aimed to explore whether cervical sagittal alignment can be maintained after CDR and to identify the impact of cervical sagittal alignment on outcomes after CDR. Methods This was a single-center, retrospective study. 132 patients who underwent one-level CDR were included. Cervical sagittal alignments, including cervical lordosis (CL), segmental alignment (SA), sagittal vertical axis (SVA), T1 slope (T1s), and T1s minus CL (T1s-CL), were measured. The effects of cervical sagittal alignment on the CDR outcomes were analyzed. Patients were divided into the heterotopic ossification (HO) group and ASD group to determine the potential impacts of cervical sagittal parameters. Results The cervical sagittal alignment parameters, except for the SVA, were significantly improved after CDR and showed decreasing trends at the last follow-up. Significantly higher CL and T1s were found in patients with better ROM after CDR. SVA ≥ 20 mm increased the risk of anterior HO (odds ratio = 2.945, P = 0.007). Significantly kyphotic SA and lower T1s values were found in the ASD patients than in the non-ASD patients (P < 0.05). Patients with ASD at the inferior level showed significantly worse CL (P < 0.05). Conclusion CDR had limited function of improving cervical sagittal alignment. Poor cervical sagittal alignment after CDR was associated with HO, ASD, and less ROM.

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Intermediate Clinical Outcome of Bryan Cervical Disc Replacement for Degenerative Disk Disease and Its Effect on Adjacent Segment Disks

Orthopedics ◽

10.3928/01477447-20120525-33 ◽

2012 ◽

Vol 35 (6) ◽

pp. e909-e916 ◽

Cited By ~ 24

Author(s):

Chen Ding ◽

Ying Hong ◽

Hao Liu ◽

Rui Shi ◽

Tao Hu ◽

...

Keyword(s):

Clinical Outcome ◽

Disc Replacement ◽

Cervical Disc ◽

Adjacent Segment ◽

Cervical Disc Replacement ◽

Degenerative Disk Disease

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Early development and progression of heterotopic ossification in cervical total disc replacement

Journal of Neurosurgery Spine ◽

10.3171/2011.8.spine11303 ◽

2012 ◽

Vol 16 (1) ◽

pp. 31-36 ◽

Cited By ~ 38

Author(s):

Soo Eon Lee ◽

Chun Kee Chung ◽

Tae Ahn Jahng

Keyword(s):

Clinical Outcome ◽

Heterotopic Ossification ◽

Total Disc Replacement ◽

Disc Replacement ◽

Adjacent Segment ◽

Segmental Motion ◽

Cervical Total Disc Replacement ◽

The Mean ◽

Grade Iii

Object The purpose of cervical total disc replacement (TDR) is to decrease the incidence of adjacent segment disease through motion preservation. Heterotopic ossification (HO) is a well-known complication after hip and knee arthroplasties. There are few reports regarding HO in patients undergoing cervical TDR, however; and the occurrence of HO and its effects on cervical motion have rarely been reported. Moreover, temporal progression of HO has not been fully addressed. One goal of this study involved determining the incidence of HO following cervical TDR, as identified from plain radiographs, and demonstrating the progression of HO during the follow-up period. A second goal consisted of determining whether segmental motion could be preserved and identifying the relationship between HO and clinical outcomes. Methods The authors conducted a retrospective clinical and radiological study of 28 consecutive patients who underwent cervical TDR with Mobi-C prostheses (LDR Medical) between September 2006 and October 2008. Radiological outcomes were evaluated using lateral dynamic radiographs obtained preoperatively and at 1, 3, 6, 12, and 24 months postoperatively. The occurrence of HO was interpreted on lateral radiographs using the McAfee classification. Cervical range of motion (ROM) was also measured. The visual analog scale (VAS) and Neck Disability Index (NDI) were used to evaluate clinical outcome. Results The mean follow-up period was 21.6 ± 7.0 months, and the mean occurrence of HO was at 8.0 ± 6.6 months postoperatively. At the last follow-up, 18 (64.3%) of 28 patients had HO: Grade I, 6 patients; Grade II, 8 patients; Grade III, 3 patients; and Grade IV, 1 patient. Heterotopic ossification progression was proportional to the duration of follow-up; HO was present in 3 (10.7%) of 28 patients at 1 month; 7 (25.0%) of 28 patients at 3 months; 11 (42.3%) of 26 patients at 6 months; 15 (62.5%) of 24 patients at 12 months; and 17 (77.3%) of 22 patients at 24 months. Cervical ROM was preserved in Grades I and II HO but was restricted in Grades III and IV HO. Clinical improvement according to the VAS and NDI was not significantly correlated with the occurrence of HO. Conclusions The overall incidence of HO after cervical TDR was relatively high. Moreover, HO began unexpectedly to appear early after surgery. Heterotopic ossification progression was proportional to the time that had elapsed postoperatively. Grade III or IV HO can restrict the cervical ROM and may lead to spontaneous fusion; however, the occurrence of HO did not affect clinical outcome. The results of this study indicate that a high incidence of HO with the possibility of spontaneous fusion is to be expected during long-term follow-up and should be considered before performing cervical TDR.

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