INTRODUCTION: The Swiss Ministry of Health has mandated a national registry for lumbar Disc Replacement (TDR). We report on an average of 14‐months results.
METHODS: In a prospective observational multicenter mode 593 patients (679 implants) were documented. Data collection was performed with EQ‐5D, NASS (patient preop, postop) and comorbidity (patient preop) as well as OP‐ and FU‐forms (surgeons). Descriptive statistics and multivariate logistic regressions were performed for a pain relief of >=18 points and EQ‐5D score improvement of >=0.25.
RESULTS: A significant reduction of back (VAS 70‐27) and leg pain (VAS 54‐19) preoperative to 2‐years FU was documented (p<0.001). Quality of life (QoL) improved from 0.33 to 0.79 (p<0.001). At the latest follow‐up, the amount of patients that needed pain medication decreased to 34.2% (preop 97.5%). The rates of intraoperative complications for mono‐ and bisegmental interventions were 4.5% and 5.8% and for postoperative complications 10.9% and 12.8%, respectively. The revision rates were 3.6% and 1.3%.
Preoperative back pain (p<0.001; OR=1.6), preoperative EQ‐score (p=0.036; OR=2.4) and number of segments (p=0.036; 2 vs. 1 OR=2.2) had an influence on the postoperative back pain relief. Preoperative leg pain (p<0.001; OR=1.8), preoperative EQ‐score (p<0.001; OR=4.9) and number of segments (p=0.036; OR=2.2) had an influence on the postoperative leg pain relief. The preoperative EQ‐5D score (p<0.001; OR=0.01) and preoperative leg pain (p=0.028; OR=0.9) had a significant influence on postoperative QoL improvement. Odds ratios were calculated per preoperative unit of 10 VAS‐points and 1 EQ‐5D point.
DISCUSSION: In the short term lumbar TDR appears as a relatively safe and also effective procedure concerning pain reduction and improvement of QoL. Preoperative pain and QoL values significantly influence their own outcome. A two level procedure has a more than two times higher likelihood for a minimum clinically relevant back and leg pain relief than a one level procedure.