Abstract
Purpose
The aim of this study was to document, at mid-term follow-up, the clinical and MRI outcome of a polyurethane-based cell-free scaffold implanted to treat painful partial meniscus loss.
Methods
Eighteen consecutive patients were enrolled and treated with arthroscopic polyurethane meniscal scaffold implantation and, in case of other comorbidities, with concurrent surgical procedures: 16 patients (9 men and 7 women, mean age 45 ± 13 years, mean BMI 25 ± 3, 12 medial and 4 lateral implants) were prospectively evaluated with the subjective and objective IKDC and the Tegner scores at 24, 36, 48, 60, and 72 months of follow-up. Eleven patients were also evaluated by 1.5-T MRI at the final follow-up.
Results
The IKDC subjective score showed a significant improvement from baseline to 24 months (45.6 ± 17.5 and 75.3 ± 14.8, respectively; p = 0.02) and subsequent stable results over time for up to 72 months (final score 75.0 ± 16.8). The Tegner score improvement between pre-operative status and final follow-up was also significant (p = 0.039). Nevertheless, the final score remained significantly lower than the pre-injury sports activity level (p = 0.027). High-resolution MRIs documented the presence of abnormal findings in terms of morphology, signal intensity, and interface between the implant and the native meniscus. Implant extrusion and bone oedema at the treated compartment were also observed in most of the cases, even though no correlation was found between imaging findings and clinical outcome.
Conclusions
The present study reports satisfactory clinical outcomes at mid-term follow-up after polyurethane-based meniscal cell-free scaffold implantation. The treatment was effective both in cases of isolated partial meniscal lesions and in complex cases requiring the combination with other surgical procedures. On the other hand, a high rate of altered MRI aspects was documented. However, no correlation was found between the altered imaging parameters and the overall positive clinical findings, thus supporting the use of this procedure to treat painful partial meniscus loss.
Level of evidence
Case series, Level IV.
Similar content being viewed by others
References
Abrams GD, Frank RM, Gupta AK, Harris JD, McCormick FM, Cole BJ (2013) Trends in meniscus repair and meniscectomy in the United States, 2005–2011. Am J Sports Med 41(10):2333–2339
Alhalki MM, Hull ML, Howell SM (2000) Contact mechanics of the medial tibial plateau after implantation of a medial meniscal allograft. A human cadaveric study. Am J Sports Med 28(3):370–376
Baynat C, Andro C, Vincent JP, Schiele P, Buisson P, Dubrana F, Gunepin FX (2014) Actifit synthetic meniscal substitute: experience with 18 patients in Brest, France. Orthop Traumatol Surg Res 100(8 Suppl):S385–S389
Bouyarmane H, Beaufils P, Pujol N, Bellemans J, Roberts S, Spalding T, Zaffagnini S, Marcacci M, Verdonk P, Womack M, Verdonk R (2014) Polyurethane scaffold in lateral meniscus segmental defects: clinical outcomes at 24 months follow-up. Orthop Traumatol Surg Res 100(1):153–157
Bulgheroni E, Grassi A, Bulgheroni P, Marcheggiani Muccioli GM, Zaffagnini S, Marcacci M (2015) Long-term outcomes of medial CMI implant versus partial medial meniscectomy in patients with concomitant ACL reconstruction. Knee Surg Sports Traumatol Arthrosc 23(11):3221–3227
Bulgheroni P, Bulgheroni E, Regazzola G, Mazzola C (2013) Polyurethane scaffold for the treatment of partial meniscal tears. Clinical results with a minimum two-year follow-up. Joints 1(4):161–166
De Coninck T, Huysse W, Verdonk R, Verstraete K, Verdonk P (2013) Open versus arthroscopic meniscus allograft transplantation: magnetic resonance imaging study of meniscal radial displacement. Arthroscopy 29(3):514–521
De Coninck T, Huysse W, Willemot L, Verdonk R, Verstraete K, Verdonk P (2013) Two-year follow-up study on clinical and radiological outcomes of polyurethane meniscal scaffolds. Am J Sports Med 41(1):64–72
de Groot JH (2005) Polyurethane scaffolds for meniscal tissue regeneration. Med Device Technol 16(7):18–20
Di Matteo B, Perdisa F, Gostynska N, Kon E, Filardo G, Marcacci M (2015) Meniscal scaffolds—preclinical evidence to support their use: a systematic review. Open Orthop J 9:143–156
Di Matteo B, Tarabella V, Filardo G, Vigano A, Tomba P, Marcacci M (2013) Thomas Annandale: the first meniscus repair. Knee Surg Sports Traumatol Arthrosc 21(9):1963–1966
Efe T, Getgood A, Schofer MD, Fuchs-Winkelmann S, Mann D, Paletta JR, Heyse TJ (2012) The safety and short-term efficacy of a novel polyurethane meniscal scaffold for the treatment of segmental medial meniscus deficiency. Knee Surg Sports Traumatol Arthrosc 20(9):1822–1830
Faivre B, Bouyarmane H, Lonjon G, Boisrenoult P, Pujol N, Beaufils P (2015) Actifit(R) scaffold implantation: Influence of preoperative meniscal extrusion on morphological and clinical outcomes. Orthop Traumatol Surg Res 101(6):703–708
Filardo G, Andriolo L, Kon E, de Caro F, Marcacci M (2015) Meniscal scaffolds: results and indications. A systematic literature review. Int Orthop 39(1):35–46
Filardo G, Kon E, Di Martino A, Perdisa F, Busacca M, Tentoni F, Balboni F, Marcacci M (2014) Is the clinical outcome after cartilage treatment affected by subchondral bone edema? Knee Surg Sports Traumatol Arthrosc 22(6):1337–1344
Gale DR, Chaisson CE, Totterman SM, Schwartz RK, Gale ME, Felson D (1999) Meniscal subluxation: association with osteoarthritis and joint space narrowing. Osteoarthr Cartil 7(6):526–532
Gelber PE, Isart A, Erquicia JI, Pelfort X, Tey-Pons M, Monllau JC (2015) Partial meniscus substitution with a polyurethane scaffold does not improve outcome after an open-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc 23(1):334–339
Gelber PE, Petrica AM, Isart A, Mari-Molina R, Monllau JC (2015) The magnetic resonance aspect of a polyurethane meniscal scaffold is worse in advanced cartilage defects without deterioration of clinical outcomes after a minimum two-year follow-up. Knee 22(5):389–394
Genovese E, Angeretti MG, Ronga M, Leonardi A, Novario R, Callegari L, Fugazzola C (2007) Follow-up of collagen meniscus implants by MRI. Radiol Med 112(7):1036–1048
Gomoll AH, Filardo G, Almqvist FK, Bugbee WD, Jelic M, Monllau JC, Puddu G, Rodkey WG, Verdonk P, Verdonk R, Zaffagnini S, Marcacci M (2012) Surgical treatment for early osteoarthritis. Part II: allografts and concurrent procedures. Knee Surg Sports Traumatol Arthrosc 20(3):468–486
Hardeman F, Corten K, Mylle M, Van Herck B, Verdonk R, Verdonk P, Bellemans J (2015) What is the best way to fix a polyurethane meniscal scaffold? A biomechanical evaluation of different fixation modes. Knee Surg Sports Traumatol Arthrosc 23(1):59–64
Heijink A, Gomoll AH, Madry H, Drobnic M, Filardo G, Espregueira-Mendes J, Van Dijk CN (2012) Biomechanical considerations in the pathogenesis of osteoarthritis of the knee. Knee Surg Sports Traumatol Arthrosc 20(3):423–435
Jones RS, Keene GC, Learmonth DJ, Bickerstaff D, Nawana NS, Costi JJ, Pearcy MJ (1996) Direct measurement of hoop strains in the intact and torn human medial meniscus. Clin Biomech (Bristol, Avon) 11(5):295–300
Kise NJ, Drogset JO, Ekeland A, Sivertsen EA, Heir S (2015) All-inside suture device is superior to meniscal arrows in meniscal repair: a prospective randomized multicenter clinical trial with 2-year follow-up. Knee Surg Sports Traumatol Arthrosc 23(1):211–218
Kon E, Filardo G, Tschon M, Fini M, Giavaresi G, Marchesini Reggiani L, Chiari C, Nehrer S, Martin I, Salter DM, Ambrosio L, Marcacci M (2012) Tissue engineering for total meniscal substitution: animal study in sheep model—results at 12 months. Tissue Eng Part A 18(15–16):1573–1582
Kon E, Filardo G, Zaffagnini S, Di Martino A, Di Matteo B, Marcheggiani Muccioli GM, Busacca M, Marcacci M (2014) Biodegradable polyurethane meniscal scaffold for isolated partial lesions or as combined procedure for knees with multiple comorbidities: clinical results at 2 years. Knee Surg Sports Traumatol Arthrosc 22(1):128–134
Lee SJ, Aadalen KJ, Malaviya P, Lorenz EP, Hayden JK, Farr J, Kang RW, Cole BJ (2006) Tibiofemoral contact mechanics after serial medial meniscectomies in the human cadaveric knee. Am J Sports Med 34(8):1334–1344
Lyman S, Hidaka C, Valdez AS, Hetsroni I, Pan TJ, Do H, Dunn WR, Marx RG (2013) Risk factors for meniscectomy after meniscal repair. Am J Sports Med 41(12):2772–2778
Monllau JC, Gelber PE, Abat F, Pelfort X, Abad R, Hinarejos P, Tey M (2011) Outcome after partial medial meniscus substitution with the collagen meniscal implant at a minimum of 10 years’ follow-up. Arthroscopy 27(7):933–943
Paletta GA Jr, Manning T, Snell E, Parker R, Bergfeld J (1997) The effect of allograft meniscal replacement on intraarticular contact area and pressures in the human knee. A biomechanical study. Am J Sports Med 25(5):692–698
Pengas IP, Assiotis A, Nash W, Hatcher J, Banks J, McNicholas MJ (2012) Total meniscectomy in adolescents: a 40-year follow-up. J Bone Joint Surg Br 94(12):1649–1654
Schuttler KF, Haberhauer F, Gesslein M, Heyse TJ, Figiel J, Lorbach O, Efe T, Roessler PP (2016) Midterm follow-up after implantation of a polyurethane meniscal scaffold for segmental medial meniscus loss: maintenance of good clinical and MRI outcome. Knee Surg Sports Traumatol Arthrosc 24(5):1478–1484
Schuttler KF, Pottgen S, Getgood A, Rominger MB, Fuchs-Winkelmann S, Roessler PP, Ziring E, Efe T (2015) Improvement in outcomes after implantation of a novel polyurethane meniscal scaffold for the treatment of medial meniscus deficiency. Knee Surg Sports Traumatol Arthrosc 23(7):1929–1935
Spencer SJ, Saithna A, Carmont MR, Dhillon MS, Thompson P, Spalding T (2012) Meniscal scaffolds: early experience and review of the literature. Knee 19(6):760–765
Szomor ZL, Martin TE, Bonar F, Murrell GA (2000) The protective effects of meniscal transplantation on cartilage. An experimental study in sheep. J Bone Joint Surg Am 82(1):80–88
Tegner Y, Lysholm J (1985) Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res 198:43–49
Verdonk P, Beaufils P, Bellemans J, Djian P, Heinrichs EL, Huysse W, Laprell H, Siebold R, Verdonk R (2012) Successful treatment of painful irreparable partial meniscal defects with a polyurethane scaffold: two-year safety and clinical outcomes. Am J Sports Med 40(4):844–853
Verdonk PC, Verstraete KL, Almqvist KF, De Cuyper K, Veys EM, Verbruggen G, Verdonk R (2006) Meniscal allograft transplantation: long-term clinical results with radiological and magnetic resonance imaging correlations. Knee Surg Sports Traumatol Arthrosc 14(8):694–706
Verdonk R, Verdonk P, Huysse W, Forsyth R, Heinrichs EL (2011) Tissue ingrowth after implantation of a novel, biodegradable polyurethane scaffold for treatment of partial meniscal lesions. Am J Sports Med 39(4):774–782
Verdonk R, Volpi P, Verdonk P, Van der Bracht H, Van Laer M, Almqvist KF, Vander Eecken S, Prospero E, Quaglia A (2013) Indications and limits of meniscal allografts. Injury 44(Suppl 1):S21–S27
Verma NN, Kolb E, Cole BJ, Berkson MB, Garretson R, Farr J, Fregly B (2008) The effects of medial meniscal transplantation techniques on intra-articular contact pressures. J Knee Surg 21(1):20–26
Vundelinckx B, Vanlauwe J, Bellemans J (2014) Long-term subjective, clinical, and radiographic outcome evaluation of meniscal allograft transplantation in the knee. Am J Sports Med 42(7):1592–1599
Wang Y, Dempsey AR, Lloyd DG, Mills PM, Wrigley T, Bennell KL, Metcalf B, Hanna F, Cicuttini FM (2012) Patellofemoral and tibiofemoral articular cartilage and subchondral bone health following arthroscopic partial medial meniscectomy. Knee Surg Sports Traumatol Arthrosc 20(5):970–978
Wyland DJ, Guilak F, Elliott DM, Setton LA, Vail TP (2002) Chondropathy after meniscal tear or partial meniscectomy in a canine model. J Orthop Res 20(5):996–1002
Zaffagnini S, Marcheggiani Muccioli GM, Bulgheroni P, Bulgheroni E, Grassi A, Bonanzinga T, Kon E, Filardo G, Busacca M, Marcacci M (2012) Arthroscopic collagen meniscus implantation for partial lateral meniscal defects: a 2-year minimum follow-up study. Am J Sports Med 40(10):2281–2288
Zaffagnini S, Marcheggiani Muccioli GM, Grassi A, Bonanzinga T, Filardo G, Canales Passalacqua A, Marcacci M (2011) Arthroscopic lateral collagen meniscus implant in a professional soccer player. Knee Surg Sports Traumatol Arthrosc 19(10):1740–1743
Zaffagnini S, Marcheggiani Muccioli GM, Lopomo N, Bruni D, Giordano G, Ravazzolo G, Molinari M, Marcacci M (2011) Prospective long-term outcomes of the medial collagen meniscus implant versus partial medial meniscectomy: a minimum 10-year follow-up study. Am J Sports Med 39(5):977–985
Acknowledgments
The authors thank Dr. Elettra Pignotti for her statistical assistance.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
G. Filardo is a consultant and receives institutional support from Finceramica Faenza Spa (Italy), Fidia Farmaceutici Spa (Italy), and CartiHeal (2009) Ltd (Israel). He is a consultant for EON Medica SRL (Italy). He receives institutional support from IGEA Clinical Biophysics (Italy), Biomet (USA), and Kensey Nash (USA). S. Zaffagnini received financial support from I + srl, Italy, and he has royalties from Springer, Germany. He receives institutional support from Fidia Farmaceutici Spa (Italy), CartiHeal (2009) Ltd (Israel), IGEA Clinical Biophysics (Italy), Biomet (USA), and Kensey Nash (USA). M. Marcacci receives royalties and research institutional support from Fin-Ceramica Faenza SpA (Italy). He receives institutional support from Fidia Farmaceutici Spa (Italy), CartiHeal (2009) Ltd (Israel), IGEA Clinical Biophysics (Italy), Biomet (USA), and Kensey Nash (USA). E. Kon is consultant for CartiHeal (2009) Ltd (Israel) and has stocks of CartiHeal (2009) Ltd (Israel). She is a consultant and receives institutional support from Finceramica Faenza Spa (Italy). She receives institutional support from Fidia Farmaceutici Spa (Italy), IGEA Clinical Biophysics (Italy), Biomet (USA), and Kensey Nash (USA). The other authors declare that they have no conflict of interest.
Rights and permissions
About this article
Cite this article
Filardo, G., Kon, E., Perdisa, F. et al. Polyurethane-based cell-free scaffold for the treatment of painful partial meniscus loss. Knee Surg Sports Traumatol Arthrosc 25, 459–467 (2017). https://doi.org/10.1007/s00167-016-4219-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00167-016-4219-6