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Table 1 Characteristics of the included studies

From: Multi-layer cell-free scaffolds for osteochondral defects of the knee: a systematic review and meta-analysis of clinical evidence

Author
Journal
Year
Study
Design
Evaluated
Patients
Age (years)
Sex (M/F)
BMI (Kg/m2)
Mean F-UP (months) Treated Disease Size
Location
Classification
Scaffold Results and Failures CMS
Kon et al
AJSM
2021 [39]
Prospective
Case Series
86 37.4 ± 10.0
60 M/26F
26.1 ± 3.5
24 Chondral and osteochondral lesions in mild to moderate OA 3.0 ± 1.7 cm2
44 MFC/15 LFC/
13 Trochlea/14 multiple
ICRS III—IV
Agili-C™
(CartiHeal)
Significant improvement of all clinical scores. MRI showed a significant increase in defect filling over time. Eight failures 54
Van Genechten et al
Cartilage
2021 [72]
Prospective
Case Series
13 33.5 ± 8.9
10 M/3F
25.3 ± 3.4
36 Chondral and osteochondral lesions in mild to moderate OA 2.6 ± 1.7 cm2
6 MFC/ 2 LFC/
5 Trochlea
ICRS III—IV
Agili-C™
(CartiHeal)
Statistically significant improvement of all clinical scores evaluated at 36 months. No failures 47
Guerin et al
Orthop Traumatol
Surg Res
2020 [34]
Retrospective
Case Series
17 28 ± 9
9 M/8 F
-
46 Osteochondral lesions 4.5 ± 1.4 cm2
12 MFC/4 LFC/1 Tibia
-
MaioRegen
(Finceramica)
Good clinical outcomes in large knee osteochondral defects without correlation with MRI results. Failures not reported 34
Sessa et al
Cartilage
2020 [68]
Prospective
Case Series
20 16.2 ± 1.4
14 M/6F
21 ± 2.1
72 Osteochondral lesions in juvenile OCD 3.2 ± 1.8 cm2
9 MFC/8 LFC/3 Trochlea
ICRS III—IV
MaioRegen
(Finceramica)
Clinical improvement stable over time with a high survival rate, although with persisting abnormal MRI findings. No failures 51
Shivji et al
J. Orthop
2020 [69]
Prospective
Case Series
11 46 ± 13.7
4 M/7F
-
121 Chondral and osteochondral lesions 4.3 cm2 (2.9—8.0)
35 plugs implanted:
17 MFC/4 LFC/1 Patella
13 Trochlea
ICRS III-IV
TruFit®
(Smith&Nephew)
No statistically significant improvements in any clinical score evaluated also confirmed by MRI results. Four failures 45
Wang et al
Cartilage
2020 [74]
Retrospective
Comparative
Study
66 42.9 ± 12.8
37 M/29F
26.7 ± 7.7
40 Chondral and osteochondral lesions 3 ± 1.7 cm2
36 MFC/15 LFC/
15 Trochlea
ICRS III-IV
TruFit®
(Smith&Nephew)
vs
Microfracture
Activity level and MRI appearance in the scaffold group were superior than microfracture group. One failure 63
D'Ambrosi et al
Int Orthop
2019 [13]
Prospective
Case Series
21 51.3 ± 10.7
14 M/7F
27.2 ± 3.3
60 Chondral and osteochondral lesions -
-
ICRS IV
TruFit®
(Smith&Nephew)
Good clinical outcome with stable results at long-term F-UP. No correlations with MRI results. Two failures 49
Sessa et al
J Clin Med
2019 [67]
Prospective
Case Series
22 39.0 ± 8.2
19 M/3F
25.0 ± 2.2
60 Chondral and osteochondral lesions in early OA 3.2 ± 1.9 cm2
10 MFC/9 LFC/
1 Patella/6 Trochlea/
5 multiple
ICRS III—IV
MaioRegen
(Finceramica)
Significant clinical improvement and stable outcome with low complication and failure rates. Two failures 44
Azam et al
J. Orthop
2018 [4]
Retrospective
Case Series
10 35.2 (22–49)
7 M/3F
-
24 Chondral and osteochondral lesions -
10 MFC/2 LFC
-
TruFit®
(Smith&Nephew)
All patients showed a significant but small clinical improvement. Failures not reported 24
Bugelli et al
Musculoskelet Surg
2018 [9]
Retrospective
Case Series
5 64.4 (38–80)
4 M/1F
-
71 Ostechondral lesions -
7 MFC/ 1Trochlea
ICRS III-IV
TruFit®
(Smith&Nephew)
Clinical and radiological results significantly improve in a longer F-UP time
No failures
33
Condello et al
BioMed Research
International
2018 [12]
Prospective
Case Series
26 43.8 ± 11.2
18 M/8F
27.3 ± 4.3
35 Osteochondral lesions in early OA -
17 MFC/3 Patella/
6 Trochlea
ICRS III – IV
MaioRegen
(Finceramica)
Clinical outcomes showed significant improvement in 69% of the patients, although no correlations with radiological images results were found. No failures 46
Kon et al
KSSTA
2018 [40]
Randomized
Controlled
Trial
51 34.0 ± 10.9
36 M/15F
25.6 ± 3.3
24 Chondral and osteochondral lesions 3.4 ± 1.5 cm2
37 FC/12 Patella/
2 Trochlea
ICRS III—IV
MaioRegen
(Finceramica)
vs
Microfracture
A statistically significant improvement of all clinical scores was described from basal evaluation to 2 years F-UP. Two failures 67
Mathis et al
KSSTA
2018 [56]
Prospective
Case Series
14 33.1 ± 10.7
11 M/3F
27 ± 4
12 Osteochondral lesions 1.0–3.5 cm2
8 MFC/2 LFC/
2 Patella/2 Trochlea
ICRS III—IV
MaioRegen
(Finceramica)
Significant clinical improvement at 1-year F-UP although an ongoing defect filling was found at the same F-UP. Failures not reported 27
Perdisa et al
AJSM
2018 [64]
Prospective
Case Series
27 25.5 ± 7.7
19 M/8F
23.0 ± 2.7
60 OCD lesions 3.4 ± 2.2 cm2
17 MFC/10 LFC
ICRS III—IV
MaioRegen
(Finceramica)
Significant improvement of clinical scores at each F-UP, although not correlated with MRI findings. No failures 46
Perdisa et al
AJSM
2017 [62]
Prospective
Case Series
34 30 ± 10
18 M/16F
24 ± 3
24 Chondral and osteochondral lesions 2 ± 1 cm2
34 Patella
ICRS III—IV
MaioRegen
(Finceramica)
A statistically significant improvement in all scores was observed at 12–24 months of F-UP. No failures 48
Berruto et al
Knee
2016 [7]
Prospective
Case Series
11 52.1 ± 9.6
5 M/6F
23.9 ± 1.6
24 Late-stage osteonecrosis of the knee 3.47 ± 1.75 cm2
11 MFC
11 SPONK
MaioRegen
(Finceramica)
Clinical scores improved significantly at 1 year of F-UP, remaining stable at 2 years. Two failures 33
Brix et al
Int Orthop
2016 [8]
Prospective
Case Series
8 37 (15–51)
6 M/2F
-
24 Osteochondral lesions 2.07 cm2 (1.5–3.75)
5 MFC/3 LFC
ICRS III—IV
MaioRegen
(Finceramica)
Clinical scores improved without reaching statistical significance at 2 years of F-UP. T2 mapping described a limited quality of repair cartilage tissue. No failures 45
Christensen et al
KSSTA
2016 [11]
Prospective
Case Series
6 -
-
-
30 Osteochondral lesions -
3 MFC/1 Patella
-
MaioRegen
Finceramica)
A significant clinical improvement was described, while MRI showed no improvement at any time point. Two failures 48
Dell’Osso et al
Musculoskelet Surg
2016 [17]
Retrospective
Case Series
31 60.6 (32–79)
16 M/15F
-
48 Osteochondral lesions -
43 TruFit plugs:
39 MFC/3 LFC/1 Trochlea
-
TruFit®
(Smith&Nephew)
Good clinical outcome at final F-UP. MRI showed partial integration of the scaffolds always with centripetal mode. One failure 27
Kon et al
Injury
2016 [47]
Prospective
Comparative
Study
21 31.0 ± 8.6
17 M/4F
26.2 ± 3.4
12 Chondral and osteochondral lesions 2.5 ± 1.7 cm2
11 MFC/4 LFC/
6 Trochlea
ICRS III—IV
Agili-C™
(CartiHeal)
Tapered
A statistically significant improvement in all clinical scores evaluated without significant differences between the two groups
No failures in the tapered group, while 8 failures in the Cylindrical group
46
76 31.7 ± 7.8
62 M/14F
25.1 ± 3.4
12 Chondral and osteochondral lesions 1.7 ± 1.0 cm2
45 MFC/25 LFC/
6 Trochlea
ICRS III—IV
Agili-C™
(CartiHeal)
Cylindrical
Dhollander et al
Acta Orthop. Belg
2015 [18]
Prospective
Case Series
20 31.7 (17–53)
8 M/12F
-
34 Chondral and osteochondral lesions 0.83 cm2 (0.38–1.58)
8 MFC/4 LFC/
5 Patella/3 Trochlea
ICRS III—IV
TruFit®
(Smith&Nephew)
Significant clinical improvement at final F-UP, while the MRI showed a significant tendency of repair tissue deterioration. Six failures 51
Di Martino et al
Injury
2015 [20]
Prospective
Case Series
23 38.0 ± 8.2
19 M/4F
25 ± 2.9
24 Chondral and osteochondral lesions in early OA 3.2 ± 1.9 cm2
12 MFC/9 LFC/1 Tibia/
1 Patella/6 Trochlea
ICRS III—IV
MaioRegen
(Finceramica)
Significant clinical improvement with better clinical results in younger patients. MOCART showed a complete integration of graft in 66.7% of cases. Two failures 38
Verdonk et al
BJJ
2015 [73]
Prospective
Case Series
38 30.5 ± 11.9
23 M/15F
-
24 Osteochondral lesions 3.7 ± 2.4 cm2
23 MFC/7 LFC/
5 Patella/3 Trochlea
ICRS III – IV
TruFit®
(Smith&Nephew)
Significant improvement of clinical scores and MOCART score at final F-UP. Two failures 48
Berruto et al
AJSM
2014 [6]
Prospective
Case Series
49 37 ± 14
37 M/12F
-
24 Osteochondral lesions 4.4 ± 1.3 cm2
33 MFC/ 11 LFC/
1 Trochlea/4 Tibia
ICRS III-IV
MaioRegen
(Finceramica)
Statistically clinical improvement at 2 years F-UP. MRI evaluation showed a complete filling of the lesion in 70% of cases. Three failures 55
Delcogliano et al
Joints
2014 [16]
Prospective
Case Series
23 24
19 M/4F
25.5 ± 7.7
24 OCD lesions 3.5 ± 1.4 cm2
14 MFC/9 LFC
ICRS III—IV
MaioRegen
(Finceramica)
Promising stable results at short-term F-UP
MRI scans showed complete filling of the defect in 80% of cases. No failures
54
Delcogliano et al
KSSTA
2014 [15]
Prospective
Case Series
19 26 ± 8
16 M/5F
-
24 Osteochondral lesions 5.2 ± 1.6 cm2
10 MFC/7 LFC/3 Tibia
ICRS III—IV
MaioRegen
(Finceramica)
Promising stable results at short-term F-UP
Two failures
44
Gelber et al
The Knee
2014 [29]
Prospective
Case Series
57 36 (25–53)
51 M/6F
25 ± 3
45 Chondral and osteochondral lesions 3.6 cm2 (2.8—3.9)
22 MFC/15 LFC/
20 Trochlea
ICRS III—IV
TruFit®
(Smith&Nephew)
Clinical scores improved at final F-UP, but alterations of subchondral bone and lamina were observed at MRI evaluation. One failure 54
Hindle et al
KSSTA
2014 [36]
Retrospective
Comparative
Study
35
(66)
38.6 ± 13.3
M/F
27.9 ± 5.4
22 Chondral and osteochondral lesions -
-
-
TruFit®
(Smith&Nephew)
vs
Mosaicplasty
Mosaicplasty group had a higher rate of returning to sport and higher KOOS score compared to scaffold group. Five failures in the scaffold group 24
Kon et al
AJSM
2014 [41]
Prospective
Case Series
27 34.9 ± 10.2 18 M/9F
-
60 Chondral and osteochondral lesions 2.9 ± 1.3 cm2
7 MFC/5 LFC/11 Patella/
7 Trochlea/2 Tibia
ICRS III—IV
MaioRegen
(Finceramica)
A statistically significant improvement of all scores at final F-UP, although not correlated with MRI results. Failures not reported 47
Kon et al
J Mater Sci
Mater Med
2014 [43]
Prospective
Case Series
79 31.0 ± 11.3 63 M/16F
-
24 Chondral and osteochondral lesions 3.2 ± 2 cm2
41 MFC/26 LFC/
15 Trochlea
III-IV
MaioRegen
(Finceramica)
A statistically significant improvements in all scores although not correlated with MRI findings. Three failures 49
Kon et al
Injury
2014 [46]
Prospective
Case Series
11 37.3 ± 11.0
6 M/5F
21.6 ± 2.6
24 Osteochondral lesions 5.1 ± 2.7 cm2
2 Femur/11 Tibia
III – IV
MaioRegen
(Finceramica)
Clinical scores significantly improved at final F-UP of 2 years. No failures 34
Filardo et al
AJSM
2013 [24]
Prospective
Case Series
27 25.5 ± 7.7
19 M/8F
23.0 ± 2.7
24 OCD lesions 3.4 ± 2.2 cm2
17 MFC/10 LFC
ICRS III—IV
MaioRegen
(Finceramica)
Good clinical outcome at 2-year of F-UP. Less favorable findings obtained with MRI. Failures not reported 43
Joshi et al
AJSM
2012 [37]
Prospective
Case Series
10 33.3 (16–49)
4 M/6F
28.8 (23–37)
24 Osteochondral lesions 2.6 cm2 (1–5)
Patella
III-IV
TruFit®
(Smith&Nephew)
Good clinical results at 12 months in knee without concomitant injuries, with a worsening after 18 months of F-UP. Seven failures 55
Kon et al
AJSM
2011 [38]
Prospective
Case Series
28 35.3 ± 10.2
19 M/9F
-
24 Chondral and osteochondral lesions 2.9 ± 1.3 cm2
8 MFC/5 LFC/12 Patella/
7 Trochlea/2 Tibia
ICRS III – IV
MaioRegen
(Finceramica)
Clinical scores significantly improved at final F-UP of 2 years. Two failures 48
  1. BMI Body mass index, CMS Modified Coleman Methodology Score, F Female, F-UP Follow-up, ICRS International Cartilage Repair Society score, KOOS Knee Injury and Osteoarthritis Outcome score, LFC Lateral femoral condyle, M Male, MFC Medial femoral condyle, MOCART Magnetic Resonance Observation of Cartilage Repair Tissue score, MRI Magnetic resonance imaging, OA Osteoarthritis, OCD Osteochondritis dissecans, SPONK Spontaneous osteonecrosis of the knee