Surgical Treatment of Clavicular Fractures, Refractures, Delayed and Non-Unions Using a Resorbable, Gentamicin-Eluting Calcium Sulphate/Hydroxyapatite Biocomposite

Figures & data

Figure 1 Defect and plate augmented with injectable bone graft substitute.

Table 1 Demographics and Baseline Characteristics

Variables	Values
Age (mean, range)	50.1 (16–79)
Sex (n, %)
Male	16 (64%)
Female	9 (36%)
Male:Female ratio	1.8
Diagnosis (n, %)
Displaced primary fracture	18 (69.2%)
Refracture	4 (15.4%)
Delayed Union	2 (7.7%)
Non-union	2 (7.7%)
Location (n, %)
Right	13 (50%)
Left	13 (50%)
Left:Right ratio	1
Shaft/Diaphyseal third	17 (65.4%)
Lateral third	7 (26.9%)
Medial third	2 (7.7%)
Primary Fracture classification (n, %)
Allman type 1	9 (50.0%)
Allman type 2	7 (38.9%
Allman type 3	2 (11.1%)
Plate Fixation
Superior (n, %)	25 (96.2%)
Anterior-superior (n, %)	1 (3.8%)
Relevant comorbidities (n, %)
Yes	6 (24%)
No	19 (76%)
Diabetes type 2 (NID)	1
Diabetes type 2 (ID)	1
Osteoporosis	1
Suspected plasmocytoma	1
Prostate carcinoma	1
Prostate adenoma	1
Epilepsy	1*
Adrenal adenoma (left)	1*
Obesity	1

Note: *Patient with bilaterally fractured clavicles.

Table 2 Radiographic, Clinical and Functional Outcomes

Variables	Values
Follow-up [months] (mean±SD, range)	14.9±8.7 (6–31)
6–12 months (n, %)	13 (50%)
13–18 months (n, %)	7 (26.9%)
>18 months (n, %)	6 (23.1%)
Bony Union
Goldberg Score (mean±SD)	7±0
Complications/Adverse Events
Yes (n, %)	0 (0%)
No (n, %)	26 (100%)
UCLA Shoulder Score (mean±SD, range)	34.6±0.8 (32–35)
35 points (n, %)	19 (73.1%)
32–34 points (n, %)	7 (26.9%)
QuickDASH Score (mean±SD, range)	0.6±1.6 (0–5.4)
0 points (n, %)	22 (84.6%)
1–6 points	4 (15.4%)
Range of Motion (neutral-zero-method)
No limitations
Abduction/Adduction 180-0-20 (−40) (n, %)	22 (84.6%)
Anteversion/Retroversion 150 (−170)-0-40 (n, %)	22 (84.6%)
Range of Motion limitations
Overall cases	4 (15.4%)
Abduction reduction of ≤10° (n, %)	3 (11.5%)
Abduction reduction of 11°-≤20° (n, %)	1 (3.8%)
Anteversion reduction of ≤10° (-≤ 30°) (n, %)	4 (15.4%)
Retroversion reduction of ≤10° (n, %)	1 (3.8%)
SF-12 physical component score, (mean±SD, range)	57.7±1.7 (54.1–58.9)
Pain, VAS (mean±SD)	0±0

Figure 2 Displaced Allman type 1 fracture with free fragment; (A) preoperative axial radiograph; (B) postoperative axial radiograph after ORIF with a plate and screws and augmentation of both the bone defect and the plate with gentamicin-loaded bone graft substitute; (C) axial radiograph at 6 months showing bony consolidation; (D and E) coronal computed tomography (CT) scan at six months, various layers; and (F) transversal CT scan at 6 months confirming excellent bony consolidation.

Figure 3 Refracture; (A) axial radiograph following initial surgical treatment of an Allman type 1 fracture without defect augmentation; (B) axial radiograph following implant removal; (C) axial radiograph of the refracture following implant removal; (D) post-operative axial radiograph after ORIF and defect/implant augmentation, (E) axial radiograph at 12 months revealing excellent radiographic union; and (F) axial radiograph upon implant removal at 18 months.

Figure 4 Delayed union after non-surgical treatment of an Allman type 1 fracture; (A) axial radiograph of a little displaced shaft fracture; (B) axial radiograph at 2 months revealing delayed union; (C) anterior-posterior (AP) radiograph confirming delayed union; (D) axial radiograph following surgical intervention with resection of the delayed union and debridement, ORIF and filling of the residual bone defect with CERAMENT G; (E) axial radiograph and (F)AP radiograph at 12 months showing excellent bony union.