Table 2.
Patient reported outcome measures (PROM) at baseline, 6 weeks, and at months 3, 6, 12, and 24.
| Patient reported outcome measures | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age group | Time interval | Group | N | ODI |
VAS-worst leg pain |
VAS-low back pain |
ZCQ |
|||||
| Mean (SD) | MCID | Mean (SD) | MCID | Mean (SD) | MCID | Symptom, MCID | Physical, MCID | Satisfaction, MCID | ||||
| All Patients | Preoperative | TOPS | 206 | 56.5 (12.1) | 82.7 (13.5) | 68.6 (23.3) | ||||||
| Fusion | 93 | 55.8 (13.1) | 85.1 (10.8) | 69.5 (22.2) | ||||||||
| 6 weeks | TOPS | 194 | 23.5 (16.4)* | 84.0 | 12.9 (20.5) | 92.8 | 18.5 (18)* | 83.5* | 93.8 | 86.7* | 96.4 | |
| Fusion | 84 | 30.2 (17) | 73.8 | 17.9 (25.2) | 92.8 | 27.7 (25.3) | 68.7 | 90.5 | 76.2 | 95.2 | ||
| Month 3 | TOPS | 183 | 15.7 (16.5)* | 89.1 | 13.3 (22.5) | 94.5 | 16.2 (21.3)* | 83.6 | 95.6 | 91.2 | 94 | |
| Fusion | 82 | 22.1 (17.8) | 84.1 | 15.9 (23.7) | 92.7 | 23.1 (24.5) | 79.3 | 96.3 | 91.4 | 95.1 | ||
| Month 6 | TOPS | 171 | 13.4 (15.5) | 91.8 | 12.9 (22.7) | 92.4 | 14.7 (21.1)* | 86 | 95.9 | 90.6 | 94.7 | |
| Fusion | 74 | 16.0 (15.9) | 90.5 | 17 (24.9) | 91.9 | 22.7 (24.8) | 79.7 | 93.2 | 91.9 | 95.9 | ||
| Month 12 | TOPS | 143 | 11.6 (13.7)* | 94.4 | 12.8 (22) | 94.4 | 12.4 (19.6)* | 86 | 96.5 | 96.5* | 94.4 | |
| Fusion | 65 | 16.9 (17.2) | 89.2 | 18.7 (27.8) | 90.8 | 24.5 (27.6) | 76.9 | 92.3 | 84.6 | 86.2 | ||
| Month 24 | TOPS | 96 | 9.4 (14.5)* | 93.8* | 13.7 (24.2) | 90.6 | 11.1 (18.1)* | 84.4* | 93.8 | 92.7 | 92.7 | |
| Fusion | 35 | 21.1 (22.3) | 77.1 | 23.3 (33.8) | 88.2 | 30.9 (33.1) | 61.8 | 85.7 | 82.9 | 88.6 | ||
| Patients <65 years | Preoperative | TOPS | 111 | 56.8 (12.2) | 82.7 (13.3) | 72 (23.2) | ||||||
| Fusion | 43 | 56.5 (12.4) | 85.3 (12.2) | 71.1 (22.4) | ||||||||
| 6 weeks | TOPS | 106 | 24.7 (16.6) | 84.0 | 13.7 (21.6) | 89.6 | 19.8 (18.2) | 84* | 94.3 | 86.9 | 96.3 | |
| Fusion | 38 | 30.5 (17.4) | 78.9 | 20.2 (27.6) | 91.9 | 27.4 (24.8) | 64.9 | 86.8 | 76.3 | 92.1 | ||
| Month 3 | TOPS | 100 | 15.3 (16.6) | 89.0 | 11.9 (21.2) | 95 | 18 (22.8) | 82 | 94.9 | 93 | 97 | |
| Fusion | 36 | 21.9 (17.8) | 80.6 | 15.1 (22.9) | 91.7 | 25.8 (25.3) | 72.2 | 100 | 97.1 | 97.1 | ||
| Month 6 | TOPS | 90 | 13.7 (16.0) | 90.0 | 12.9 (22.9) | 91.1 | 15.6 (22.6) | 86.7 | 97.8 | 92.2 | 95.6 | |
| Fusion | 34 | 16.8 (15.9) | 91.2 | 14.6 (23.1) | 91.2 | 23.3 (23.6) | 76.5 | 97.1 | 91.2 | 97.1 | ||
| Month 12 | TOPS | 78 | 11.8 (14.9) | 92.3 | 12.4 (20)* | 94.9 | 13.4 (19.4)* | 85.9 | 97.4 | 96.2* | 93.6 | |
| Fusion | 31 | 18.1 (17.9) | 87.1 | 23.6 (32.6) | 83.9 | 28.6 (30.9) | 71 | 90.3 | 83.9 | 80.6 | ||
| Month 24 | TOPS | 51 | 7 (13.1)* | 94.1* | 8.7 (17)* | 96.1 | 9.5 (18.7)* | 86.3* | 96.1* | 96.1 | 94.1 | |
| Fusion | 17 | 26.4 (25.6) | 64.7 | 28.3 (39.4) | 81.3 | 35.3 (35.5) | 50 | 76.5 | 70.6 | 76.5 | ||
| Patients ≥ 65 years | Preoperative | TOPS | 95 | 56.2 (12.0) | 82.7 (13.8) | 64.6 (22.8) | ||||||
| Fusion | 50 | 55.2 (13.7) | 84.9 (9.6) | 68.1 (22.2) | ||||||||
| 6 weeks | TOPS | 88 | 22.0 (16.2)* | 84.1 | 12 (19.2) | 96.6 | 16.9 (17.6)* | 83 | 93.2 | 86.4 | 96.6 | |
| Fusion | 46 | 30.0 (16.8) | 69.6 | 16 (23.3) | 93.5 | 27.9 (26) | 71.7 | 93.5 | 76.1 | 97.8 | ||
| Month 3 | TOPS | 83 | 16.1 (16.5)* | 89.2 | 15 (23.9) | 93.9 | 14.2 (19.2) | 85.5 | 96.3 | 89 | 90.2 | |
| Fusion | 46 | 22.3 (18.0) | 87.0 | 16.6 (24.5) | 93.5 | 20.9 (23.8) | 84.8 | 93.5 | 87 | 93.5 | ||
| Month 6 | TOPS | 81 | 13.1 (15.0) | 93.8 | 13 (22.6) | 93.8 | 13.8 (19.3)* | 85.2 | 93.8 | 88.9 | 93.8 | |
| Fusion | 40 | 17.0 (16.2) | 90.0 | 19.1 (26.4) | 92.5 | 22.2 (26) | 82.5 | 90 | 92.5 | 95 | ||
| Month 12 | TOPS | 65 | 11.3 (12.3) | 96.9 | 13.2 (24.3) | 93.8 | 11.2 (19.9)* | 86.2 | 95.4 | 96.9* | 95.4 | |
| Fusion | 34 | 15.8 (16.7) | 91.2 | 14.2 (22.1) | 97.1 | 20.8 (24) | 82.4 | 94.1 | 85.3 | 91.2 | ||
| Month 24 | TOPS | 45 | 12.1 (15.6) | 93.3 | 19.4 (29.5) | 84.4 | 13 (17.3) | 82.2 | 91.1 | 88.9 | 91.1 | |
| Fusion | 18 | 16.0 (17.8) | 88.9 | 18.8 (28.5) | 94.4 | 27 (31.3) | 72.2 | 94.4 | 94.4 | 100 | ||
Abbreviations: MCID, minimal clinically important difference; N, number of patients; ODI, Oswestry Disability Index; SD standard deviation; TOPS, total posterior spine system; VAS, Visual Analog Scale; ZCQ, Zurich Claudication Questionnaire.
Minimal clinically important difference (MCID) is reported as a percentage of the cohort. MCID for each PROM are ≥15-point improvement ODI, ≥0.5-point improvement ZCQ Symptoms and Physical, ≤2.5 total ZCQ Satisfaction, and ≥20-point improvement VAS worst leg and low back.
⁎
Significant difference (p<.05) between TOPS and fusion groups by unpaired T-test (means) or Fisher's exact test (MCID).