Composite Clinical Success Summary of Incremental CCS Analyses at Month 48 Including Indicators of Treatment Sustainability.
| Endpoint | ILS | fusion |
|---|---|---|
| CCS - No 2nd Tx & ODI improvement ≥15 | 57.6% (106/ 184) | 46.7% (42/ 90) |
| Treated level success (no fusion in ILS, fusion in fusion) | 64.5% (78/ 121) | 69.7% (46/ 66) |
| CCS - No 2nd Tx & ODI improvement ≥15, treated level success | 42.7% (79/ 185) | 33.3% (30/ 90) |
| Adjacent level success (change in adjacent level rotation not ≥4 deg) | 87.1% (108/ 124) | 69.2% (45/ 65) |
| CCS - No 2nd Tx & ODI improvement ≥15, adjacent level success | 52.4% (97/ 185) | 34.4% (31/ 90) |
| CCS - No 2nd Tx & ODI improvement ≥15, treated & adjacent level success | 38.2% (71/ 186) | 25.6% (23/ 90) |
| Maintenance of foraminal height success | 87.2% (109/ 125) | N/A |
| CCS - No 2nd Tx & ODI improvement ≥15, treated & adjacent level success & maintenance of foraminal height | 36.6% (68/ 186) | 25.6% (23/ 90) |
Summary of percentages of patients achieving composite clinical success (CCS) when factors hypothesized to be associated therapeutic sustainability are added to the success criteria in incremental fashion. Endpoints indicated with CCS are responder definitions applicable to all evaluable patients. The endpoints on rows without ‘CCS’ are additional success criteria added to CCS from the line above in order to form the CCS criteria for the line below.