Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment

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Fig. 1
Kaplan-Meier survival curves by device group. A) Distributions of times from index surgery to first reoperation, revision, removal or supplemental fixation at a treated level. B) Distributions of times from index surgery to reoperation at a treated level or steroid injection at any lumbar level.
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Fig. 2
Empirical cumulative distribution functions for ILS and fusion for changes from baseline to month 48 in adjacent level (above) rotation (degrees).

Table 1

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.