Rotator cuff repair augmentation with a porcine dermal patch

1. Randomized controlled prospective
trial for rotator cuff tear repair with
medialized single row suture anchors
and augmentation with porcine
dermal patch
Avanzi Paolo, Dei Giudici Luca, Lunardi Gianluigi, Gigante Antonio, Zorzi Claudio
Ospedale Sacrocuore Don Calabria Negrar-VR, Italy
Università Politecnica delle Marche, Ancona, Italy

2. PURPOSE
MRI assessment of
anatomical integrity
medialized single row
rotator cuff repairs
augmented by porcine
dermal membrane vs a
not augmented group

3. DESIGN
Prospective - Monocentric - Randomized -
Controlled
Sample size analysis
Paerson’s chi-squared test
healing proportion of 40% in group B (no
patch) versus 70% in group A (with
patch); α=0.05 - β=0.80
46 patients each group

4. INCLUSION CRITERIA
• 50-80 y.o.
• Degenerative tears
• Anterosuperior-superior and
posterosuperior
• Early or Late Ellman retraction type
• Negative or Neutral Fuchs index
• 0-1-2 Goutallier infiltration grades

5. ESCLUSION CRITERIA
• Concomitant shoulder pathologies
• Previous surgeries
• Corticoids injections in the 6 months
before enrollment
• Connective tissue disorders
• Infective and rheumatoid diseases

6. SURGICAL TECHNIQUE
All patients
Biceps tenotomy + decompression
Medial peek anchors

7. Augmentation according to randomization
SURGICAL TECHNIQUE
Goal Post Technique
• 2 simple stiches
medially, @ MT
junction
• Lateral TOE
fixation, 2 crossing
sutures, metal
anchorswww.vumedi.com/video/goal-post-
technique-for-arthroscopic-biological-
augmentation-of-rotator-cuff-repair/

8. END POINTS
Primary
• Better tendon
healing for
sperimental group
Secondary
• Larger footprint
• Better MRI tendon signal intensity
• Better recover

9. EVALUATIONS
Shoulder high-field MRI
4 categories: healed, thinned but complete,
partial not healead, not healed
Baseline, 1month, 6months, 12months
Clinical outcome tools
[VAS – Constant-Murray – Dash – SST]
Baseline, 3months, 6months, 12months

10. GROUP
O-A
DISTANCE
CTRL STUD
Y
TOTAL
5-7 mm 1 7 8
>7mm 45 39 84
TOTAL 46 46 92
DESCRIPTIVE ANALYSIS
Sup
61%Ant-Superior
2%
Post-
Sup
24%
Sup/Ant-Sup
11%
Sup/Post-Sup
2%
LESION SITE - CONTROL GROUP
Sup
59%
Ant-Superior
2%
Post-
Sup
28%
Sup/Ant-Sup
4%
Sup/Post-Sup
7%
LESION SITE - STUDY GROUP
Homogeneous
groups

11. DESCRIPTIVE ANALYSIS
0
5
10
15
20
25
30
Crescent V L post L ant U
LESION SHAPE - CONTROL GROUP
0
5
10
15
20
25
30
Crescent V L post L ant U
LESION SHAPE - STUDY GROUP

12. GROUP
GOUTALLIE
R
CTRL STUDY TOTAL
0 15 17 32
1 22 22 44
2 9 7 16
TOTAL 46 46 92
GROUP
FUCHS CTRL STUDY TOTAL
Negative 19 18 37
Neutral 0 1 1
TOTAL 46 46 92
DESCRIPTIVE ANALYSIS

13. ML EXTENSION MEAN
CTRL 16,6
STUDY 19,9
TOTAL 18,34
AP EXTENSION MEAN
CTRL 15,16
STUDY 17
TOTAL 16,10
THICKNESS MEAN
CTRL 4,95
STUDY 4,62
TOTAL 4,78
DESCRIPTIVE ANALYSIS
Lesion characteristics

14. Healed VS Others
Chi square test
GROUP OTHERS HEALED
CTRL 22
47,83%
24
52,17%
STUDY 3
6,67%
42
93,33%
P<0,001
INFERENTIAL ANALYSIS
GROUP OTHERS HEALED
CTRL 27
58,70%
19
41,30%
STUDY 8
17,39%
38
82,61%
GROUP OTHERS HEALED
CTRL 25
55,56%
20
44,44%
STUDY 7
15,56%
38
84,44%
1 Month
12 Months
6 Months

15. INFERENTIAL ANALYSIS
GROUP OTHER
S
HEALED/THINNED
CTRL 11
23,91%
35
76,09%
STUDY 1
2,22%
44
97,78%GROUP OTHER
S
HEALED/THINNED
CTRL 14
30,43%
32
69,57%
STUDY 2
4,35%
44
95,65%GROUP OTHER
S
HEALED/THINNED
CTRL 15
33,33%
30
66,67%
STUDY 2
4,44%
43
95,56%
Healed/Thinned
Chi square test
P<0,001
1 Month
12 Months
6 Months

16. INFERENTIAL ANALYSIS
GROUP OBSERVATION
S
M-W EXPECTE
D
CTRL 46 1719,5 2139
STUDY 46 2558,2 2139GROUP OBSERVATION
S
M-W EXPECTE
D
CTRL 46 1716 2139
STUDY 46 2562 2139GROUP OBSERVATIONS M-W EXPECTE
D
CTRL 45 1634 2047,5
STUDY 45 2461 2047,5
MRI Footprint
Mann-Whitney test P<0,001
1 Month
12 Months
6 Months

17. INFERENTIAL ANALYSIS
0
10
20
30
40
50
60
70
80
90
100
Baseline 3 months 6 months 12 months
Mean QVAS score
STUDY CTRL

18. 1 TRAUMATIC MOBILIZATION @ 8 MONTHS
COMPLICATIONS
- Scaffold integration
- Tendon-like architecture and cellularity
- Minimal infiltration and degeneration

19. CONCLUSIONS
• Endpoints met: augmentation provides
high healing rates, better repair quality,
improved functional recovery
• Results are maintained up to 12 months
• Scaffold integrates and the repair shows
tendon-like features at 8months
• Easy, reproducible, but expensive repair
• No complications up to 12 months