Background
Methods
Design
Study population
Selection criteria
Inclusion criteria | |
Adults (aged 16 years or above) presenting within 3 weeks of their injury with a radiologically confirmed displaced fracture of the humerus involving the surgical neck | |
This should include all 2-part surgical-neck fractures; 3-part (including surgical neck) and 4-part fractures of proximal humerus (Neer classification). It may also include displaced surgical-neck fractures that do not meet the exact displacement criteria of the Neer classification (1 cm or/and 45° angulation of displaced parts) where this reflects an individual surgeon’s equipoise (e.g. whether or not the surgical-neck fracture should be treated surgically) | |
Exclusion criteria | Number of patients excludeda |
1. Associated dislocation of the injured shoulder joint | 101 |
2. Open fracture | 2 |
3. Mentally incompetent patient: unable to understand trial procedure or instructions for rehabilitation; significant mental impairment that would preclude compliance with rehabilitation and treatment advice | 116 |
4. Co-morbidities precluding surgery/anaesthesia | 179 |
5. A clear indication for surgery such as severe soft-tissue compromise requiring surgery/emergency treatment (nerve injury/dysfunction) | 87 |
6. Multiple injuries: same limb fractures; other upper limb fractures | 72 |
7. Pathological fractures (other than osteoporotic) | 5 |
8. Terminal illness | 5 |
9. Participant not resident in trauma-centre catchment area | 28 |
Data collection and outcome measures
Surgeon preferences, n (%) | Patient preferences, n (%) | Agreed treatment, n (%) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Patient group | Total n | Quest1 | Surgery | Not surgery | Uncertain | Missing | Quest1 | Surgery | Not surgery | No preference | Missing | Quest1 | Surgery | Not surgery | Missing |
Excluded (total) | 687 |
a
| 232 (34%) | 384 (56%) | – | 71 (10%) | – | – | – | – | – | – | – | – | – |
Excluded based on lack of equipoise | 117 |
a
| 41 (35%) | 58 (50%) | – | 18 (15%) |
–
| – | – | – | – | – | – | – | – |
Non-consenting | 313 |
b
| 66 (21%) | 105 (34%) | 118 (38%) | 24 (8%) |
c
| 55 (18%) | 226 (72%) | 23 (7%) | 9 (3%) |
d
| 60 (19%) | 242 (77%) | 11 (4%) |
Randomised | 250 | – | – | – | – | – |
e
| 72 (29%) | 60 (24%) | 115 (46%) | 3 (1%) |
f
| 125 (50%) | 125 (50%) | 0 (0%) |
Followed up at 2 years | 218 | – | – | – | – | – |
g
| 86 (39%) | 70 (32%) | 54 (25%) | 8 (4%) | – | – | – | – |
Statistical analyses
Results
Summary of recruitment and follow-up
Surgeon preferences
Excluded patients | Eligible patients | |||||||
---|---|---|---|---|---|---|---|---|
A Excluded based on exclusion criteria or other valid reason | B Other sole reason for exclusion assessed to be lack of equipoise | C Total | D Non-consent | E Consented and randomised | F Total | p value for B vs F1 | p value for D vs E2 | |
Characteristic | (N = 570) | (N = 117) | (N = 687) | (N = 313) | (N = 250) | (N = 563) | ||
Gender | ||||||||
Male, n (%) | 160 (28%) | 25 (21%) | 185 (27%) | 75 (24%) | 58 (23%) | 133 (24%) | 0.5863 | 0.8003 |
Female, n (%) | 404 (72%) | 92 (79%) | 496 (73%) | 236 (76%) | 192 (77%) | 428 (76%) | ||
Missing, n | 6 | 0 | 6 | 2 | 0 | 2 | ||
Age (years) | ||||||||
N | 531 | 113 | 644 | 298 | 250 | 548 | ||
Mean (SD) | 70.6 (16.77) | 69.9 (14.63) | 70.5 (16.41) | 68.5 (13.04) | 66.0 (11.94) | 67.4 (12.60) | 0.0624 | 0.0224 |
Median | 74.1 | 72.0 | 73.6 | 70.6 | 66.9 | 69.1 | ||
< 65 years, n (%) | 180 (34%) | 32 (28%) | 212 (33%) | 109 (37%) | 108 (43%) | 217 (40%) | 0.0243 | 0.1143 |
≥ 65 years, n (%) | 351 (66%) | 81 (72%) | 432 (67%) | 189 (63%) | 142 (57%) | 331 (60%) | ||
Missing, n | 39 | 4 | 43 | 15 | 0 | 15 | ||
Fracture type | ||||||||
One or both tuberosities involved, n (%) | 342 (60%) | 69 (59%) | 411 (60%) | 229 (73%) | 193 (77%) | 422 (75%) | < 0.0013 | 0.2723 |
Neither tuberosity involved, n (%) | 228 (40%) | 48 (41%) | 276 (40%) | 84 (27%) | 57 (23%) | 141 (25%) | ||
Affected shoulder | ||||||||
Left, n (%) | 273 (51%) | 62 (54%) | 335 (51%) | 160 (53%) | 125 (50%) | 285 (52%) | 0.6563 | 0.4863 |
Right, n (%) | 266 (49%) | 53 (46%) | 319 (49%) | 142 (47%) | 125 (50%) | 267 (48%) | ||
Missing, n | 31 | 2 | 33 | 11 | 0 | 11 | ||
Days since injury | ||||||||
N | 570 | 117 | 687 | 313 | 250 | 563 | 0.8535 | 0.1115 |
Mean (SD) | 4.9 (4.93) | 5.6 (5.41) | 5.0 (5.01) | 5.2 (4.72) | 5.7 (4.89) | 5.4 (4.80) | ||
Median | 3 | 3 | 3 | 4 | 4 | 4 |
Characteristic | Surgeon preference (for patients excluded due to lack of equipoise, n = 117) | Patient preference (of non-consenting patients, n = 313) | ||||
---|---|---|---|---|---|---|
Surgery | Not surgery | p value | Surgery | Not surgery | p value | |
Gender | ||||||
Male, n (%) | 11 (48%) | 12 (52%) | 0.4761 | 11 (17%) | 55 (83%) | 0.4761 |
Female, n (%) | 30 (39%) | 46 (61%) | 44 (21%) | 169 (79%) | ||
Age (years) | ||||||
N | 41 | 56 | 53 | 214 | ||
Mean (SD) | 68.0 (2.06) | 72.4 (1.76) | 0.1052 | 65.1 (15.59) | 69.2 (12.21) | 0.0392 |
Median | 68.8 | 75.0 | 69.3 | 70.7 | ||
< 65 years, n (%) | 16 (57%) | 12 (43%) | 0.0591 | 23 (23%) | 77 (77%) | 0.3181 |
≥ 65 years, n (%) | 25 (36%) | 44 (64%) | 30 (18%) | 137 (82%) | ||
Fracture type | ||||||
One or both tuberosities involved, n (%) | 23 (43%) | 31 (57%) | 0.7941 | 44 (22%) | 160 (78%) | 0.1701 |
Neither tuberosity involved, n | 18 (40%) | 27 (60%) | 11 (14%) | 66 (86%) | ||
Affected shoulder | ||||||
Left, n (%) | 15 (31%) | 34 (69%) | 0.0521 | 28 (20%) | 109 (80%) | 0.9531 |
Right, n (%) | 24 (50%) | 24 (50%) | 27 (20%) | 107 (80%) | ||
Days since injury | ||||||
N | 41 | 58 | 55 | 226 | ||
Mean (SD) | 6.5 (5.83) | 4.7 (4.94) | 0.2533 | 5.5 (5.26) | 5.2 (4.68) | 0.9123 |
Median | 4 | 2 | 4 | 3 |
Patient preferences
Patient preference at baselinea Randomised allocation (n) | |||||||
---|---|---|---|---|---|---|---|
Surgery | Not surgery | No preference | |||||
Patient preference at 24 months | Surgery | Not surgery | Surgery | Not surgery | Surgery | Not surgery | |
(n = 41) | (n = 31) | (n = 32) | (n = 28) | (n = 52) | (n = 63) | ||
Surgery, n (%) | 25 (61%) | 5 (16%) | 12 (38%) | 3 (11%) | 27 (52%) | 12 (19%) | |
Not surgery, n (%) | 4 (10%) | 12 (39%) | 8 (25%) | 20 (71%) | 3 (6%) | 22 (35%) | |
No preference, n (%) | 7 (17%) | 9 (29%) | 5 (16%) | 4 (14%) | 12 (23%) | 17 (27%) | |
Missing, n (%) | 5 (12%) | 5 (16%) | 7 (22%) | 1 (4%) | 10 (19%) | 12 (19%) |