Abstract
An analysis of employment status data up to 10 years following the Federal Drug Administration (FDA) Investigational Device Exemption (IDE) randomized trial and extension as post-approval study comparing BRYAN cervical disc (Medtronic, Minneapolis, MN) arthroplasty (CDA) versus single-level anterior cervical discectomy and fusion (ACDF) was performed.
Ten-year experience with the BRYAN disc arthroplasty trial provides opportunity to report patient employment data.
The long-term consequences of arthroplasty remain incomplete, including the occurrence of occupational compromise.
Patients' employment status were measured at regular intervals in both groups up to 10 years.
The preoperative employment status proportion was comparable between investigational (BRYAN CDA) and control (ACDF) groups. In the investigational group, 49.2% returned to work at 6 weeks compared with 39.4% of the control group (P = 0.046). At 6 months and 2 years postoperatively, there was a similar likelihood of active employment in both groups. After 2 years at all time points, 10% drop-off seen in control group employment, but not in investigational group. At 10 years, 76.2% CDA patients were employed to 64.1% ACDF patients (P = 0.057). Preoperative variables influencing work status at 10 years following CDA included: preoperative work status, age, and SF-36 Mental Component Score (SF-36 MCS); whereas, no significant preoperative factor identified with ACDF. Time to return to work was influenced in both groups by preoperative work status; and in the ACDF group: reaching age 65 at 10-year visit, preoperative arm pain and NDI score had significant influences.
More patients returned to work at 6 weeks after CDA compared with ACDF, although there was no difference by 6 months. After 2 years, a nonsignificant trend toward higher employment rates in the arthroplasty group was evident, but this difference could not be validated due to the very high rate of loss of patients to the follow-up.
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