Introduction
Materials and methods
Patient eligibility
Operative technique and rehabilitation protocol
Outcome measures
Primary outcome
Visual analog scale
Secondary outcomes
Functional outcome
Radiological outcome
Additional treatments and complications
Sample size calculation and power analysis
Statistical analyses
Results
Study population
Complete study population (n = 62) | Group SAD (n = 20) | Group D (n = 18) | Group D + SAD (n = 24) | p value | |
---|---|---|---|---|---|
Age in years (SD) | 53.5 (9.0) | 52.7 (10.1) | 54.9 (7.7) | 53.2 (8.8) | 0.82 |
Gender male (%) | 21 (33.9) | 7 (35.0) | 3 (16.7) | 11 (45.8) | 0.13* |
Affected side Right (%) | 47 (75.8) | 15 (75.0) | 16 (88.9) | 16 (66.7) | 0.24* |
Dominant side Right (%) | 46 (74.2) | 14 (70.0) | 16 (88.9) | 16 (66.7) | 0.20* |
Smoking status smoking (%) | 18 (29.0) | 6 (20.0) | 3 (16.7) | 9 (37.5) | 0.48* |
ASA category | |||||
1 (%) | 26 (41.9) | 8 (40.0) | 8 (44.4) | 10 (41.7) | 0.99* |
2 (%) | 32 (51.6) | 10 (50.0) | 11 (61.1) | 11 (45.8) | |
3 (%) | 4 (6.5) | 1 (5.0) | 1 (5.6) | 2 (8.3) | |
BMI Mean (SD) | 26.7 (4.3) | 26.4 (4.5) | 26 (3.5) | 27.3 (4.7) | 0.78 |
Comorbidities | |||||
Pulmonary (%) | 12 (19.4) | 4 (20.0) | 1 (5.6) | 7 (29.2) | 0.21 |
Cardiovascular (e.g., HT, hyperlipidemia) | 9 (14.5) | 2 (10.0) | 3 (16.7) | 4 (16.7) | 0.91 |
Thyroid dysfunction | 2 (3.2) | 0 | 1 (5.6) | 1 (4.2) | NA |
Diabetes mellitus | 1 (1.6) | 0 | 0 | 1 (4.2) | NA |
Duration of symptoms in months (range) | 22.2 (6–120) | 17.1 (6–120) | 20.3 (6–120) | 24.7 (6–120) | 0.57+ |
Size of deposit in mm | 23.0 (7.6) | 23.4 (6.0) | 24.7 (7.3) | 21.3 (8.6) | 0.34 |
Bosworth grade | |||||
II, medium (%) | 5 (8.1) | 1 (5) | 0 | 4 (16.7) | 0.34 |
III, large (%) | 57 (91.9) | 19 (95) | 18 (100.0) | 20 (83.3) | |
Gartner type | |||||
Type I (%) | 39 (62.9) | 15 (75.0) | 11 (61.1) | 13 (54.2) | 0.62* |
Type II (%) | 23 (37.1) | 5 (25.0) | 7 (38.9) | 11 (45.8) | |
Location of deposit | |||||
SSP (%) | 54 (87.1) | 17 (85.0) | 16 (88.9) | 21 (87.5) | 0.87* |
ISP (%) | 8 (12.9) | 3 (15.0) | 2 (11.1) | 3 (12.5) | |
SSC (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Primary outcome
Visual analog scale after 6 months
Group SAD | Group D | Group D + SAD | p value | |
---|---|---|---|---|
VAS for pain | ||||
Baseline | 58.8 (15.3) | 61.6 (16.3) | 58.1 (13.7) | 0.74 |
6 weeks | 42.3 (17.0) | 30.6 (16.8) | 25.1 (19.0) | 0.03* |
6 months | 17.0 (16.0) | 12.2 (11.7) | 11.4 (14.6) | 0.57 |
CMS | ||||
Baseline | 43.0 (13.9) | 45.1 (10.3) | 51.0 (12.9) | 0.10 |
6 weeks | 66.3 (18.0) | 72.1 (22.8) | 79.3 (16.0) | 0.77 |
6 months | 84.8 (18.0) | 89.7 (9.6) | 91.8 (11.2) | 0.84 |
DASH | ||||
Baseline | 49.2 (21.9) | 45.0 (21.1) | 45.2 (13.6) | 0.80 |
6 weeks | 37.6 (20.8) | 24.9 (16.5) | 14.7 (13.7) | 0.02* |
6 months | 16.3 (14.1) | 10.1 (11.5) | 8.2 (14.4) | 0.89 |
ASES | ||||
Baseline | 41.5 (18.0) | 40.4 (12.9) | 44.8 (12.5) | 0.63 |
6 weeks | 62.5 (21.2) | 71.9 (16.2) | 77.1 (18.7) | 0.21 |
6 months | 83.2 (15.0) | 88.9 (10.7) | 85.9 (19.3) | 0.50 |
Size of calcification | ||||
Baseline | 23.4 (6.0) | 24.7 (7.3) | 21.3 (8.6) | 0.34 |
6 weeks | 14.2 (9.4) | 10.3 (7.6) | 8.1 (6.1) | 0.02* |
6 months | 6.1 (8.9) | 1.0 (3.0) | 1.0 (2.7) | 0.03* |
Secondary outcomes
Visual analog scale after 6 weeks
Functional outcome
Radiological outcome
Group SAD | Group D | Group D + SAD | p value | |
---|---|---|---|---|
Additional treatments | 9 (45) | 4 (22.2) | 1 (4.2) | 0.004* |
NACD | 3 (15) | 0 (0.0) | 0 (0.0) | |
SAI | 6 (30) | 4 (22.2) | 1 (4.2 | |
Complications | 2 (10) | 1 (5.5) | 1 (4.2) | 0.73 |
Treatment failure | 3 (15) | 1 (5.5) | 4 (16.8) | 0.54 |