Table 1.
Synopsis of clinical studies on scaffold-based meniscal substitutes (chronological order)
| Author | Year | N | Age| | ♂ / ♀ | FU | Scaffold | M/L | A/C | Size|| | Assoc. Procedures | Radiologic Outcomes | Clinical Outcomes |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| [years] | [months] | [mm] | [%] | |||||||||
| Toanen [67] | 2020 | 155 | 34 | 109/46 | 60 | Actifit® | 101/54 | 14/141 | 39.4 | HTO (28), ACLR (19), CS (4) | Genovese score, extrusion, ICRS | VAS, LS, IKDC, KOOS, survival rate |
| Schenk [68] | 2019 | 39 | 34 | 30/9 | 36 | CMI | 32/7 | 25/14 | 48 | ACLR (62) | Genovese score, extrusion | VAS, LS, IKDC, Tegner, clinical failure |
| Monllau [69] | 2018 | 32 | 41 | 25/7 | 70.8 | Actifit® | 21/11 | N/A | 40.9 | ACLR (28), HTO (41), PCLR (3), CS (44) | Genovese score, extrusion, volume | LS, IKDC, KOOS, Tegner, |
| Leroy [70] | 2017 | 15 | 30 | 8/7 | 72 | Actifit® | 6/9 | 0/15 | N/A | ACLR (33), CS (7) | Genovese score, extrusion, ICRS | VAS, IKDC, KOOS, failure rate |
| Dhollander [71] | 2016 | 44 | 32 | 24/20 | 60 | Actifit® | 29/15 | 4/40 | 45.5 | ACLR (9), HTO (9) | Genovese score, extrusion, ICRS | VAS, IKDC, KOOS, survival rate |
| Filardo [72] | 2016 | 16 | 45 | 9/7 | 72 | Actifit® | 12/4 | N/A | N/A | ACLR (38), HTO (13), ME (94), CS (13), O (6) | Genovese score, extrusion | IKDC, Tegner |
| Schüttler [73] | 2015 | 18 | 33 | N/A | 48 | Actifit® | 18/0 | 0/18 | 44.5 | None | Genovese score, extrusion | VAS, KOOS, KSS, UCLA |
| Faivre [74] | 2015 | 20 | 29 | N/A | 24 | Actifit® | 8/12 | 0/20 | N/A | Ligament reconstruction (20), CS (15) | Signal intensity, extrusion, cartilage coverage index | IKDC, KOOS |
| Martín-Hernández [75] | 2015 | 10 | 31 | 4/6 | 24 | Actifit® | 9/1 | 0/10 | N/A | None | Genovese score, extrusion | VAS, LS, KOOS |
| Schüttler [76] | 2015 | 18 | 33 | N/A | 24 | Actifit® | 18/0 | 0/18 | 40.9 | None | Genovese score, extrusion | VAS, KOOS, KSS, UCLA |
| Baynat [77] | 2014 | 18 | 20–46 | 13/5 | 24 | Actifit® | 13/5 | 0/18 | N/A | ACL (56), HTO (56) | Genovese score, extrusion | LS, Histology |
| Gelber [78] | 2014 | 30 | 51 | 40/20 | 31.2 | Actifit® | 60/0 | 0/60 | 40.3 | HTO (100) | Radiographic evaluation of limb alignment and tibial slope | VAS, IKDC, Kujala, WOMET, |
| Bouyarmane [79] | 2014 | 54 | 28 | 37/17 | 24 | Actifit® | 0/54 | 0/54 | 43 | ACLR (17), DFO (9) | N/A | VAS, IKDC, KOOS |
| Kon [80] | 2014 | 18 | 45 | 11/7 | 24 | Actifit® | 13/5 | 1/17 | N/A | ACLR (17), Osteotomy (22), CS (39), O (17) | Genovese score | IKDC, Tegner |
| De Coninck [81] | 2013 | 26 | 35 | 12/12 | 24 | Actifit® | 18/8 | N/A | 43.2 | ACLR (23), HTO (4), DFO (4), CS (4), MAT (4) | Meniscal rim thickness, extrusion | VAS, LS, IKDC, KOOS |
| Bulgheroni [82] | 2013 | 20 | 33 | 17/2 | 24–46 | Actifit® | 17/3 | 0/20 | 43/37** | ACLR (47), HTO (37), DFO (5) | Genovese score | VAS, LS, Tegner, second-look |
| Hirschmann [83] | 2013 | 67 | 36 | 47/20 | 12 | CMI | 55/12 | 42/25 | N/A | ACLR (67), HTO (7), CS (4) | Genovese score, extrusion | VAS, LS, IKDC, Tegner, clinical failure |
| Zaffagnini [84] | 2012 | 24 | 36 | 20/4 | 26 | CMI | 0/24 | 7/17 | 45.2 | ACLR (17), CS (25), O (4) | Genovese score, Yulish score | VAS, LS, IKDC, Tegner, EQ-5D |
| Efe [85] | 2012 | 10 | 29 | 8/2 | 12 | Actifit® | 10/0 | 0/10 | 39.2 | None | Genovese score, bone bruise, ICRS, remaining meniscus | VAS, KOOS, KSS, UCLA |
| Verdonk [86] | 2012 | 52 | 31 | 39/13 | 24 | Actifit® | 34/18 | 2/46 (4 unknown) | 47.1 | ACLR (4) | ICRS | VAS, LS, IKDC, KOOS, SAE |
| Verdonk [55] | 2011 | 52 | 31 | 39/13 | 12 | Actifit® | 34/18 | 2/46 (4 unknown) | 47.1 | N/A | Tissue ingrowth (DCE-MRI), ICRS | Pain, functionality, quality of life, Histology |
| Zaffagnini | 2011 | 17 | 40 | 33/0 | 133 | CMI | 33/0 | 17/16 | 36 | ACLR (12) | Genovese score, Yulish score, Radiographic evaluation | VAS, LS, IKDC, Tegner, SF-36 |
| Monllau [87] | 2011 | 25 | 29 | 20/5 | 133.2 | CMI | 25/0 | 20/5 | 48.2 | ACLR (56), CS (4) | Genovese score, radiographic progression of OA | VAS, LS, failure rate, |
| Bulgheroni [88] | 2010 | 34 | 39 | 25/9 | 60 | CMI | 34/0 | 6/28 | 45 | ACLR (32), HTO (6), CS (3) | Genovese score, Yulish score, radiographic progression of OA | LS, Tegner, Histology |
| Rodkey [61] | 2008 | 160 | 39 | 243/68 | 59 | CMI | 311/0 | 157/154 | N/A | ACLR (27) | N/A | VAS, LS, Tegner, Histology |
| Linke [89] | 2007 | 23 | 42 | N/A | 24 | CMI | 23/0 | N/A | N/A | HTO (100) | N/A | VAS, LS, IKDC |
| Genovese [90] | 2007 | 40 | 41 | 27/13 | 12–24 | CMI | 40/0 | 28/12 | N/A | ACLR (40), HTO (3), CS (4) | Genovese score | N/A |
| Steadman [91] | 2005 | 8 | 40 | 8/0 | 69.6 | CMI | 8/0 | 1/8 | N/A | None | Signal intensity, interface, cartilage, bone marrow, radiographic evaluation of OA | VAS, LS, IKDC, Tegner, Histology |
| Rodkey [92] | 1999 | 8 | 40 | N/A | 24 | CMI | 8/0 | 1/7 | 42.5 | None | Morphology, size, radiographic progression of OA | VAS, LS, Tegner, Histology |
| Stone [54] | 1997 | 10 | 39 | 8/2 | 36 | CMI | 10/0 | 4/6 | N/A | ACLR (20) | Signal intensity, interface, radiographic evaluation of OA | VAS, activity + performance score, overall knee rating, Histology |
Abbreviations: A/C Acute/chronic; ACLR Anterior cruciate ligament reconstruction; CMI Collagen meniscus implant; CS Cartilage surgery; DCE-MRI Dynamic contrast-enhanced magnetic resonance imaging; DFO Distal femoral osteotomy; EQ-5D EuroQuol 5 dimensions; FU Follow-up; HTO High tibial osteotomy; ICRS International cartilage repair society; IKDC International knee documentation committee; KOOS Knee injury and osteoarthritis outcome score; KSS Knee society score; LS Lysholm score; M/L, medial/lateral; MAT Meniscal allograft transplantation; ME Meniscectomy; N Number of patients treated with scaffold-based meniscal substitutes; N/A Not available; O Others; OA Osteoarthritis; PCLR Posterior cruciate ligament reconstruction; SAE Scaffold-related serious adverse events; SF-36 Short form 36; UCLA University of California, Los Angeles activity scale; VAS Visual analogue scale; WOMET Western Ontario meniscal evaluation tool; |,mean age at surgery; ||, mean defect size