Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up.

OBJECTIVE Cervical total disc replacement (TDR) has been shown in a number of prospective clinical studies to be a viable treatment alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic degenerative disc disease. In addition to preserving motion, evidence suggests that cervical TDR may result in a lower incidence of subsequent surgical intervention than treatment with fusion. The goal of this study was to evaluate subsequent surgery rates up to 5 years in patients treated with TDR or ACDF at 1 or 2 contiguous levels between C-3 and C-7. METHODS This was a prospective, multicenter, randomized, unblinded clinical trial. Patients with symptomatic degenerative disc disease were enrolled to receive 1- or 2-level treatment with either TDR as the investigational device or ACDF as the control treatment. There were 260 patients in the 1-level study (179 TDR and 81 ACDF patients) and 339 patients in the 2-level study (234 TDR and 105 ACDF patients). RESULTS At 5 years, the occurrence of subsequent surgical intervention was significantly higher among ACDF patients for 1-level (TDR, 4.5% [8/179]; ACDF, 17.3% [14/81]; p = 0.0012) and 2-level (TDR, 7.3% [17/234]; ACDF, 21.0% [22/105], p = 0.0007) treatment. The TDR group demonstrated significantly fewer index- and adjacent-level subsequent surgeries in both the 1- and 2-level cohorts. CONCLUSIONS Five-year results showed treatment with cervical TDR to result in a significantly lower rate of subsequent surgical intervention than treatment with ACDF for both 1 and 2 levels of treatment. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).

Comparison of Clinical Outcomes of 1- and 2-Level Total Disc Replacement: Four-Year Results From a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial.

STUDY DESIGN: A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine. OBJECTIVE: To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up. SUMMARY OF BACKGROUND DATA: Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications. METHODS: Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases.Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery. RESULTS: Preoperative characteristics were statistically similar for the 1- and 2-level patient groups. Four-year follow-up rates were 83.1% (1-level) and 89.0% (2-level). There was no statistically significant difference between 1- and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group. CONCLUSION: A 4-year post hoc comparison of 1- and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates. LEVEL OF EVIDENCE: 1.

Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results.

OBJECT: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up. METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery. RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure. CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).

Two-level total disc replacement with Mobi-C® over 3-years / Artroplastia total de disco com Mobi-C® depois de três anos / Artroplastía total de disco con Mobi-C® después de tres años

Objective: To evaluate the safety and effectiveness of two-level total disc replacement (TDR) using a Mobi-C® Cervical Artificial Disc at the 36 month follow-up. Methods: a Prospective, randomized, controlled, multicenter clinical trial of an artificial cervical disc (Mobi-C® Cervical Artificial Disc) was conducted under the Investigational Device Exemptions (IDE) and the U.S. Food & Drug Administration (FDA) regulations. A total of 339 patients with degenerative disc disease were enrolled to receive either two-level treatment with TDR, or a two-level anterior cervical discectomy and fusion (ACDF) as control. The 234 TDR patients and 105 ACDF patients were followed up at regular time points for three years after surgery. Results: At 36 months, both groups demonstrated an improvement in clinical outcome measures and a comparable safety profile. NDI scores, SF-12 PCS scores, patient satisfaction, and overall success indicated greater statistically significant improvement from baseline for the TDR group, in comparison to the ACDF group. The TDR patients experienced lower subsequent surgery rates and a lower rate of adjacent segment degeneration. On average, the TDR patients maintained segmental range of motion through 36 months with no device failure. Conclusion: Results at three-years support TDR as a safe, effective and statistically superior alternative to ACDF for the treatment of degenerative disc disease at two contiguous cervical levels.

Objetivo: Avaliar a segurança e a eficácia da artroplastia total de disco (ATD) em dois níveis, usando o disco cervical artificial Mobi-C® aos 36 meses de acompanhamento. Métodos: Realizou-se estudo clínico prospectivo, randomizado, controlado e multicêntrico de disco cervical artificial (Mobi-C® regido pelas regulamentações de Investigational Device Exemptions (IDE, isenção do dispositivo em investigação) e da Food & Drug Administration (FDA) dos Estados Unidos. Um total de 339 pacientes com doença degenerativa de disco foi inscrito para receber tratamento com ATD em dois níveis ou discectomia cervical anterior e fusão em dois níveis (DCAF) que constituíram o grupo controle. Os 234 pacientes tratados com ATD e os 105 tratados com DCAF tiveram acompanhamento em pontos do tempo regulares durante três anos após a cirurgia. Resultados: Aos 36 meses, ambos os grupos apresentaram melhora das medidas de desfecho clínico e perfil de segurança comparável. Os escores NDI, SF-12 e PCS, a satisfação dos pacientes e o êxito geral indicaram melhora com maior significância estatística desde o início do estudo no grupo ATD, em comparação com o grupo DCAF. Os pacientes do grupo ATD tiveram percentuais menores de cirurgia subsequente e taxas inferiores de degeneração do segmento adjacente. Em média, os pacientes do grupo ATD mantiveram a amplitude de movimento segmentar nos 36 meses, sem falhas do dispositivo. Conclusão: Os resultados aos três anos corroboram que a ATD é uma alternativa segura, eficaz e estatisticamente superior à DCAF no tratamento de doenças degenerativas de disco em dois níveis cervicais contíguos.

Objetivo: Evaluar la seguridad y la eficacia de la artroplastía total de disco (ATD) en dos niveles, usando el disco cervical artificial Mobi-C® a los 36 meses de acompañamiento. Métodos: Se realizó estudio clínico prospectivo, aleatorio, controlado y multicéntrico de disco cervical artificial (Mobi-C®) regido por las reglamentaciones de Investigational Device Exemptions (IDE, exención del dispositivo en investigación) y de la Food & Drug Administration (FDA) de los Estados Unidos. Un total de 339 pacientes con enfermedad degenerativa de disco fue inscripto para recibir tratamiento con ATD en dos niveles o discectomía cervical anterior y fusión en dos niveles (DCAF) que constituyeron el grupo control. Los 234 pacientes tratados con ATD y los 105 tratados con DCAF tuvieron acompañamiento en puntos de tiempo regulares durante tres años después de la cirugía. Resultados: A los 36 meses, ambos grupos presentaron mejora de las medidas de resultado clínico y perfil de seguridad comparable. Los registros NDI, SF-12 y PCS, la satisfacción de los pacientes y el éxito general indicaron mejora con mayor significado estadístico desde el inicio del estudio en el grupo ATD, en comparación con el grupo DCAF. Los pacientes del grupo ATD tuvieron porcentuales menores de cirugía subsiguiente y tasas inferiores de degeneración del segmento adyacente. Como promedio, los pacientes del grupo ATD mantuvieron la amplitud de movimiento segmentar en los 36 meses, sin fallas del dispositivo. Conclusión: Los resultados a los tres años corroboran que la ATD es una alternativa segura, eficaz y estadísticamente superior a DCAF en el tratamiento de enfermedades degenerativas de disco en dos niveles cervicales contiguos.

Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article.

OBJECT: Cervical total disc replacement (TDR) is intended to treat neurological symptoms and neck pain associated with degeneration of intervertebral discs in the cervical spine. Anterior cervical discectomy and fusion (ACDF) has been the standard treatment for these indications since the procedure was first developed in the 1950s. While TDR has been shown to be a safe and effective alternative to ACDF for treatment of patients with degenerative disc disease (DDD) at a single level of the cervical spine, few studies have focused on the safety and efficacy of TDR for treatment of 2 levels of the cervical spine. The primary objective of this study was to rigorously compare the Mobi-C cervical artificial disc to ACDF for treatment of cervical DDD at 2 contiguous levels of the cervical spine. METHODS: This study was a prospective, randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc conducted at 24 centers in the US. The primary clinical outcome was a composite measure of study success at 24 months. The comparative control treatment was ACDF using allograft bone and an anterior plate. A total of 330 patients were enrolled, randomized, and received study surgery. All patients were diagnosed with intractable symptomatic cervical DDD at 2 contiguous levels of the cervical spine between C-3 and C-7. Patients were randomized in a 2:1 ratio (TDR patients to ACDF patients). RESULTS: A total of 225 patients received the Mobi-C TDR device and 105 patients received ACDF. At 24 months only 3.0% of patients were lost to follow-up. On average, patients in both groups showed significant improvements in Neck Disability Index (NDI) score, visual analog scale (VAS) neck pain score, and VAS arm pain score from preoperative baseline to each time point. However, the TDR patients experienced significantly greater improvement than ACDF patients in NDI score at all time points and significantly greater improvement in VAS neck pain score at 6 weeks, and at 3, 6, and 12 months postoperatively. On average, patients in the TDR group also maintained preoperative segmental range of motion at both treated segments immediately postoperatively and throughout the study period of 24 months. The reoperation rate was significantly higher in the ACDF group at 11.4% compared with 3.1% for the TDR group. Furthermore, at 24 months TDR demonstrated statistical superiority over ACDF based on overall study success rates. CONCLUSIONS: The results of this study represent the first available Level I clinical evidence in support of cervical arthroplasty at 2 contiguous levels of the cervical spine using the Mobi-C cervical artificial disc. These results continue to support the use of cervical arthroplasty in general, but specifically demonstrate the advantages of 2-level arthroplasty over 2-level ACDF. Clinical trial registration no.: NCT00389597 (ClinicalTrials.gov).