Introduction
Material and method
Trial design
Participants
Treatment regimen and randomization
Outcome measures
Statistical analysis
Power calculation
Results
Patient characteristics
Characteristics | Foot cast (n = 36) | Short leg cast (n = 36) |
---|---|---|
Age (year), mean (SD) | 41 (16.1) | 40.1 (13.5) |
Sex (%) | ||
Male | 10 (27.8) | 24 (66.7) |
Female | 26 (72.2) | 12 (33.3) |
Time after injury (hour), mean (range) | 2.03 (1–6) | 6.67 (1–24) |
Pain VAS score, mean (SD) (0–10) | 7.36 (1.57) | 6.09 (1.77) |
AOFAS, mean (SD) (0–100) | 33.6 (12.49) | 32.6 (12.64) |
- Pain, mean (range) (0–40) | 6.11 (0–20) | 6.29 (0–20) |
- Function, mean (range) (0–45) | 5.11 (0–16) | 5.08 (0–14) |
Activity limitations, mean (range) (0–10) | 2.08 (0–5) | 2.29 (0–5) |
Maximum walking distance, mean (range) (0–10) | 0.78 (0–4) | 0.91 (0–4) |
Walking surfaces, mean (range) (0–10) | 0.83 (0–5) | 0.43 (0–5) |
Gait abnormality, mean (range) (0–10) | 1.42 (0–7) | 1.6 (0–4) |
Shoes wearing, mean (range) (0–5) | 0 | 0 |
- Alignment, mean (range) (0–15) | 15 | 15 |
AOFAS score
Follow up time | Treatment | Mean differences between groups | 95%CI | P-value | |
---|---|---|---|---|---|
Foot cast | Short leg cast | ||||
VAS | |||||
2 weeks | 1.97 | 2.91 | − 0.94 | − 1.53, − 0.34 | 0.002 |
4 weeks | 0.58 | 1.23 | −0.65 | −1.24, − 0.05 | 0.033 |
6 weeks | 0.17 | 0.37 | −0.20 | −0.78, 0.39 | 0.509 |
8 weeks | 0.08 | 0.11 | −0.03 | −0.63, 0.57 | 0.922 |
AOFAS | |||||
2 weeks | 68.22 | 60.20 | 8.02 | 3.74, 12.1 | < 0.001 |
4 weeks | 82.72 | 70.20 | 12.52 | 8.27, 16.78 | < 0.001 |
6 weeks | 91.75 | 92.24 | −0.49 | −4.72, 3.74 | 0.820 |
8 weeks | 98.11 | 99.13 | −1.02 | −5.30, 3.27 | 0.642 |
Time | Foot cast | Short leg cast | ||||
---|---|---|---|---|---|---|
Mean | Within group differences | P-value | Mean | Within group differences | P-value | |
VAS | ||||||
0 week | 7.36 | – | – | 6.09 | – | – |
2 weeks | 1.97 | −5.39 | < 0.001 | 2.91 | −3.18 | < 0.001 |
4 weeks | 0.58 | −1.39 | < 0.001* | 1.23 | −1.68 | < 0.001 |
6 weeks | 0.17 | −0.42 | 0.142 | 0.37 | −0.86 | 0.003 |
8 weeks | 0.08 | −0.08 | 0.769 | 0.11 | −0.25 | 0.382 |
AOFAS | ||||||
0 week | 33.58 | – | – | 32.6 | – | – |
2 weeks | 68.22 | 34.64 | < 0.001 | 60.20 | 27.60 | < 0.001 |
4 weeks | 82.72 | 14.50 | < 0.001 | 70.20 | 10.00 | < 0.001 |
6 weeks | 91.75 | 9.03 | < 0.001 | 92.24 | 22.04 | < 0.001 |
8 weeks | 98.11 | 6.36 | 0.002 | 99.13 | 6.89 | 0.001 |