Table 6.
Summary of adverse events (patient level) within 1 year after surgery (safety population)
| Adverse eventsa | PHILOS without augmentation N = 36 | PHILOS with screw augmentation N = 29 | Total N = 65 | p valuee | |||
|---|---|---|---|---|---|---|---|
| N b | %c (95% CId) | N b | %c (95% CId) | N b | %c (95% CId) | ||
| Any adverse events | 15 | 41.7 (25.5; 59.2) | 12 | 41.4 (23.5; 61.1) | 27 | 41.5 (29.4; 54.4) | 1.000 |
| Any intraoperative adverse event | 4 | 11.1 (3.1; 26.1) | 1 | 3.4 (0.1; 17.8) | 5 | 7.7 (2.5; 17.0) | 0.370 |
| Poor intraoperative fracture reduction | 3 | 8.3 (1.8; 22.5) | 0 | 0.0 (0.0; 11.9) | 3 | 4.6 (1.0; 12.9) | – |
| Malpositioning of the plate/screw(s) | 2 | 5.6 (0.7; 18.7) | 0 | 0.0 (0.0; 11.9) | 2 | 3.1 (0.4; 10.7) | – |
| Cement leakage into the joint | 0 | 0.0 (0.0; 9.7) | 1 | 3.4 (0.1; 17.8) | 1 | 1.5 (0.0; 8.3) | – |
| Cement application into the wound | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Direct allergic reaction to Traumacem V + cement | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Direct allergic reaction to contrast media | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Implant failure/breakage | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Other bone/fracture-related AE | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Nerve injury | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Other AE related to soft tissue of the musculoskeletal system | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Other wound/local tissue-related AE | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Thromboembolic complications | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Renal insufficiency | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Stroke | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Sudden death | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Intraoperative hemodynamically relevant hemorrhage | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | - |
| Other systemic AE | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Any postoperative adverse event | 14 | 38.9 (23.1; 56.5) | 12 | 41.4 (23.5; 61.1) | 26 | 40.0 (28.0; 52.9) | 1.000 |
| Late/development of allergic reaction to Traumacem V + cement | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Late/development of allergic reaction to contrast media | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Primary/secondary screw perforation | 3 | 8.3 (1.8; 22.5) | 1 | 3.4 (0.1; 17.8) | 4 | 6.2 (1.7; 15.0) | – |
| Screw/plate loosening | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Implant failure/breakage | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Nonunion | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Delayed union | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Malunion | 0 | 0.0 (0.0; 9.7) | 1 | 3.4 (0.1; 17.8) | 1 | 1.5 (0.0; 8.3) | – |
| Loss of reduction | 2 | 5.6 (0.7; 18.7) | 1 | 3.4 (0.1; 17.8) | 3 | 4.6 (1.0; 12.9) | – |
| Humeral head necrosis | 2 | 5.6 (0.7; 18.7) | 3 | 10.3 (2.2; 27.4) | 5 | 7.7 (2.5; 17.0) | – |
| Head impaction | 1 | 2.8 (0.1; 14.5) | 0 | 0.0 (0.0; 11.9) | 1 | 1.5 (0.0; 8.3) | – |
| Other bone/fracture-related AE | 1 | 2.8 (0.1; 14.5) | 2 | 6.9 (0.8; 22.8) | 3 | 4.6 (1.0; 12.9) | – |
| Deep wound infection | 0 | 0.0 (0.0; 9.7) | 1 | 3.4 (0.1; 17.8) | 1 | 1.5 (0.0; 8.3) | – |
| Impingement | 2 | 5.6 (0.7; 18.7) | 0 | 0.0 (0.0; 11.9) | 2 | 3.1 (0.4; 10.7) | – |
| Nerve injury | 0 | 0.0 (0.0; 9.7) | 1 | 3.4 (0.1; 17.8) | 1 | 1.5 (0.0; 8.3) | – |
| Other AE related to soft tissue of the musculoskeletal system | 1 | 2.8 (0.1; 14.5) | 2 | 6.9 (0.8; 22.8) | 3 | 4.6 (1.0; 12.9) | – |
| Superficial wound infection | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Wound dehiscence | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Hematoma (requiring revision) | 1 | 2.8 (0.1; 14.5) | 0 | 0.0 (0.0; 11.9) | 1 | 1.5 (0.0; 8.3) | – |
| Other wound/local tissue-related AE | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Thromboembolic complications | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Sepsis | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Pneumonia | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Renal insufficiency | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Stroke | 0 | 0.0 (0.0; 9.7) | 1 | 3.4 (0.1; 17.8) | 1 | 1.5 (0.0; 8.3) | – |
| Sudden death | 0 | 0.0 (0.0; 9.7) | 0 | 0.0 (0.0; 11.9) | 0 | 0.0 (0.0; 5.5) | – |
| Other systemic AE | 4 | 11.1 (3.1; 26.1) | 3 | 10.3 (2.2; 27.4) | 7 | 10.8 (4.4; 20.9) | – |
The safety population was defined as all patients that have received PHILOS type of plate fixation. Patients were grouped according to the actual treatment they received. The two patients that received prothesis as the primary fixation are excluded in this table. Control group: PHILOS without augmentation. Augmented group: PHILOS with augmentation
AE adverse event, PHILOS proximal humerus internal locking system
aOnly AEs starting up to ≤ 425 days after surgery, i.e., with an onset before the upper visit window of the 1-year follow-up, were included in the table
bNumber of patients with at least one AE. If patient experienced multiple AEs under any complication class, the patient was only counted once
cEstimated risk of developing at least one AE (calculated by dividing the number of patients experiencing at least one complication by the total number of patients in the corresponding treatment group. For this table, all the patients irrespective of availability of follow-up counted in the denominator)
dConfidence intervals for percentages were calculated using the Clopper–Pearson method
eFisher’s exact test