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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-Câ„¢

(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-Câ„¢

(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-Câ„¢

(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-Câ„¢

(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