Open Access
Table 2
Summary of clinical evidence from published studies used within the NICE assessment review (adapted from Tables 1, 2, & 7 in the External Assessment Centre report).
| Study | Study design | Type of long bone fracture | Non-union (NU) or delayed healing (DH) | Mean fracture age (months) | Mean patient age (years) | Healing rate | Mean Healing time |
|---|---|---|---|---|---|---|---|
| Schofer 2010 | RCT | Tibia | DH/NU? | 13 | 43 | 65% for EXOGEN (33/51) | Not reported |
| >9 (n = 51/101) | (14–70) | 46% for placebo (23/50) | |||||
| Lerner 2004 | Case series | Femur, tibia, radius/ulna, humerus | DH | 6 (range 1–38) | 19–48 | 94% (15/16) | Mean bone union time 75 weeks (34–224) |
| Jingushi 2007 | Case series | Femur, tibia, humerus, radius, ulna | DH/NU | 19 (range 3–159) | 40 (14–83) | 83% (33/40) | Not reported separately for DU and NU |
| Mayr 2000 | Case series | Femur, tibia, fibula, radius, ulna, humerus | DH/NU | 3–9 (n = 951) | 20–71 | 76% (Humerus 41/54), | 125 days (humerus, SD 11.7) |
| >9 (n = 366) | 94% (Radius-ulna 49/52) | 115 (Radius-ulna, SD 9.3) | |||||
| 81% (Ulna 35/43) | 130 (Ulna, SD 15.3) | ||||||
| 87% (Femur (85/98) | 140 (femur (SD 8.3) | ||||||
| 92% (Tibia 350/380) | 138 (tibia SD 4.5) | ||||||
| 96% (Fibula, 26/27) | 113 (fibula, 9.6). | ||||||
| Total 90% (586/654) | Mean 4.4 months | ||||||
| Gebauer 2005 | Case series | Tibia, fibula, femur, humerus, radius, ulna | NU | >8 | 23–86 | 90% (long bones, 46/51) | 178 days (86-375) for long bone fractures |
| 85% (all fractures, 57/67) | 168 days for all fractures. | ||||||
| Nolte 2001 | Case series | Humerus, radius, ulna, femur, tibia, fibula | NU | 15 (range 6–34) | 18–90 | 100% (Tibia-fibula, 10/10) | 144 days (Tibia-tibia/fibula) |
| <9 (n = 5/21) | 80% (Femur, 4/5) | 185 (femur) | |||||
| 80% (Radius-ulna, 4/5) | |||||||
| 100% (other long bones, 2/2) | 139 (radius-radius/ulna, 4/5) | ||||||
| Duration was 2 years. | 153 (other long bones, 2/2) | ||||||
| Romano 1999 | Case series | Tibia, humerus, femur | NU (septic) | 8–30 < 9 (n = 1/13) | 28–78 | 62% (8/13 tibia, humerus, femur) | 95–181 days (3 still in treatment at time of report) |
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