Abstract
Purpose
The aim of this study is to evaluate the safety and clinical efficacy of this novel polyurethane meniscal scaffold to treat partial meniscal loss.
Methods
Eighteen patients (11 men and 7 women, mean age: 45 years) affected by irreparable acute meniscal tears requiring partial meniscectomy or chronic prior loss of meniscal tissue were enrolled in the study. They underwent arthroscopic polyurethane meniscal scaffold implantation (13 medial and 5 lateral) and, in case of presence of other comorbidities, concurrent procedures were also performed. Patients were prospectively evaluated up to 2 years of follow-up through IKDC objective, IKDC subjective, and Tegner scores. Furthermore, MRI evaluation of the meniscal scaffold was performed.
Results
No major adverse events were observed. A statistically significant increase in all the clinical parameters considered was found. The IKDC objective score increased from 61 % of normal or nearly normal knees at basal evaluation to 94 % at 2 years of follow-up (p = 0.01). There was also a significant increase in the IKDC subjective score both at 6–12 months of follow-up (p = 0.03 and p < 0.005), which was confirmed at 24 months. The Tegner score also showed a significant increase from the pre-operative level (median value 2, range 1–5) to final evaluation (median value 3, range 2–5; p = 0.005), albeit not reaching the pre-injury sports activity level.
Conclusions
The implantation of this novel polyurethane scaffold proved to be a safe and potentially effective procedure to treat partial meniscal loss with encouraging results at short-term follow-up. Further high-quality studies with larger numbers of patients and longer evaluation times are needed to confirm these preliminary data.
Level of evidence
Case series, Level IV.
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References
Aagaard H, Jorgensen U, Bojsen-Moller F (1999) Reduced degenerative articular cartilage changes after meniscal allograft transplantation in sheep. Knee Surg Sports Traumatol Arthrosc 7:184–191
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 28:370–376
Bulgheroni P, Murena L, Ratti C, Bulgheroni E, Ronga M, Cherubino P (2010) Follow-up of collagen meniscus implant patients: clinical, radiological, and magnetic resonance imaging results at 5 years. Knee 17(3):224–229
Cook JL (2005) The current status of treatment for large meniscal defects. Clin Orthop Relat Res 435:88–95
DeGroot JH (2005) Polyurethane scaffolds for meniscal tissue regeneration. Med Device Technol 16(7):18–20
Efe T, Getgood A, Schofer MD et al (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
Fairbank TJ (1948) Knee joint changes after meniscectomy. J Bone Joint Surg Br 30B:664–670
Genovese E, Angeretti MG, Ronga M et al (2007) Follow-up of collagen meniscus implants by MRI. Radiol Med 112(7):1036–1048
Gomoll AH, Filardo G, Almqvist FK et al (2012) Surgical treatment for early osteoarthritis. Part II: allografts and concurrent procedures. Knee Surg Sports Traumatol Arthrosc 20(3):468–486
Heijink A, Gomoll AH, Madry H et al (2012) Biomechanical considerations in the pathogenesis of osteoarthritis of the knee. Knee Surg Sports Traumatol Arthrosc 20(3):423–435
International Cartilage Repair Society. ICRS cartilage injury evaluation package. http://www.cartilage.org/_files/contentmanagement/ICRS_evaluation.pdf
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
Klompmaker J, Veth RP, Jansen HW et al (1996) Meniscal repair by fibrocartilage in the dog: characterization of the repair tissue and the role of vascularity. Biomaterials 17(17):1685–1691
Klompmaker J, Veth RP, Jansen HW et al (1996) Meniscal replacement using a porous polymer prosthesis: a preliminary study in the dog. Biomaterials 17(12):1169–1175
Kon E, Filardo G, Tschon M et al (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
Lee SJ, Aadalen KJ, Malaviya P et al (2006) Tibiofemoral contact mechanics after serial medial meniscectomies in the human cadaveric knee. Am J Sports Med 34:1334–1344
Maher SA, Rodeo SA, Doty SB et al (2010) Evaluation of a porous polyurethane scaffold in a partial meniscal defect ovine model. Arthroscopy 26(11):1510–1519
Monllau JC, Gelber PE, Abat F et al (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 25:692–698
Pereira H, Frias AM, Oliveira JM, Espregueira-Mendes J, Reis RL (2011) Tissue engineering and regenerative medicine strategies in meniscus lesions. Arthroscopy 27(12):1706–1719
Rodkey WG, DeHaven KE et al (2008) Comparison of the collagen meniscus implant with partial meniscectomy. A prospective randomized trial. J Bone Joint Surg Am 90(7):1413–1426
Scotti C, Pozzi A, Mangiavini L et al (2009) Healing of meniscal tissue by cellular fibrin glue: an in vivo study. Knee Surg Sports Traumatol Arthrosc 17(6):645–651
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
Steadman JR, Rodkey WG (2005) Tissue-engineered collagen meniscus implants: 5–6-year feasibility study results. Arthroscopy 21(5):515–525
Stone KR, Steadman JR, Rodkey WG, Li ST (1997) Regeneration of meniscal cartilage with use of a collagen scaffold. Analysis of preliminary data. J Bone Joint Surg Am 79(12):1770–1777
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 82:80–88
Tienen TG, Heijkants RG, Buma P, De Groot JH, Pennings AJ, Veth RP (2003) A porous polymer scaffold for meniscal lesion repair—a study in dogs. Biomaterials 24(14):2541–2548
Tienen TG, Heijkants RG, de Groot JH et al (2006) Meniscal replacement in dogs. Tissue regeneration in two different materials with similar properties. J Biomed Mater Res B Appl Biomater 76(2):389–396
Verdonk P, Beaufils P, Bellemans J et al (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 R, Verdonk P, Huysse W et al (2011) Tissue in growth after implantation of a novel, biodegradable polyurethane scaffold for treatment of partial meniscal lesions. Am J Sports Med 39(4):774–782
Verdonk PC, Verstraete KL, Almqvist KF et al (2006) Meniscal allograft transplantation: long-term clinical results with radiological and magnetic resonance imaging correlations. Knee Surg Sports Traumatol Arthrosc 14(8):694–706
Verma NN, Kolb E, Cole BJ et al (2008) The effects of medial meniscal transplantation techniques on intra-articular contact pressures. J Knee Surg 21:20–26
Weinand C, Peretti GM, Adams SB et al (2006) An allogenic cell-based implant for meniscal lesions. Am J Sports Med 34(11):1779–1789
Wirth CJ, Peters G, Milachowski KA, Weismeier KG, Kohn D (2002) Long-term results of meniscal allograft transplantation. Am J Sports Med 30(2):174–181
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, Giordano G, Vascellari A et al (2007) Arthroscopic collagen meniscus implant results at 6–8 years follow up. Knee Surg Sports Traumatol Arthrosc 15(2):175–183
Zaffagnini S, Marcheggiani Muccioli GM, Grassi A et al (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 et al (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
All the authors would like to thank Federica Balboni, Giulio Altadonna, Francesco Perdisa, Letizia Merli, Keith Smith, and Elettra Pignotti, all from the Rizzoli Orthopaedic Institute (Bologna, Italy) for their contribution in realizing this paper.
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Kon, E., Filardo, G., Zaffagnini, S. et al. 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, 128–134 (2014). https://doi.org/10.1007/s00167-012-2328-4
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DOI: https://doi.org/10.1007/s00167-012-2328-4