RESUMO
STUDY DESIGN: Retrospective review of a prospective multicenter adult spinal deformity (ASD) study. OBJECTIVE: The aim of this study was to evaluate 30-day readmissions, 90-day return to surgery, postoperative complications, and patient-reported outcomes (PROs) for matched ASD patients receiving nonhome discharge (NON), including acute rehabilitation (REHAB), and skilled nursing facility (SNF), or home (HOME) discharge following ASD surgery. SUMMARY OF BACKGROUND DATA: Postoperative disposition following ASD surgery frequently involves nonhome discharge. Little data exists for longer term outcomes for ASD patients receiving nonhome discharge versus patients discharged to home. MATERIALS AND METHODS: Surgically treated ASD patients prospectively enrolled into a multicenter study were assessed for NON or HOME disposition following hospital discharge. NON was further divided into REHAB or SNF. Propensity score matching was used to match for patient age, frailty, spine deformity, levels fused, and osteotomies performed at surgery. Thirty-day hospital readmissions, 90-day return to surgery, postoperative complications, and 1-year and minimum 2-year postoperative PROs were evaluated. RESULTS: A total of 241 of 374 patients were eligible for the study. NON patients were identified and matched to HOME patients. Following matching, 158 patients remained for evaluation; NON and HOME had similar preoperative age, frailty, spine deformity magnitude, surgery performed, and duration of hospital stay ( P >0.05). Thirty-day readmissions, 90-day return to surgery, and postoperative complications were similar for NON versus HOME and similar for REHAB (N=64) versus SNF (N=42) versus HOME ( P >0.05). At 1-year and minimum 2-year follow-up, HOME demonstrated similar to better PRO scores including Oswestry Disability Index, Short-Form 36v2 questionnaire Mental Component Score and Physical Component Score, and Scoliosis Research Society scores versus NON, REHAB, and SNF ( P <0.05). CONCLUSIONS: Acute needs must be considered following ASD surgery, however, matched analysis comparing 30-day hospital readmissions, 90-day return to surgery, postoperative complications, and PROs demonstrated minimal benefit for NON, REHAB, or SNF versus HOME at 1- and 2-year follow-up, questioning the risk and cost/benefits of routine use of nonhome discharge. LEVEL OF EVIDENCE: Level III-prognostic.
Assuntos
Fragilidade , Alta do Paciente , Adulto , Humanos , Readmissão do Paciente , Instituições de Cuidados Especializados de Enfermagem , Estudos Prospectivos , Fragilidade/complicações , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos RetrospectivosRESUMO
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.