Successful treatment of painful irreparable partial meniscal defects with a polyurethane scaffold: Two-year safety and clinical outcomes

American Journal of Sports Medicine

Volumn 40, Issue 4, 2012, Pages 844-853

  Verdonk, Peter ^a   Beaufils, Philippe ^b   Bellemans, Johan ^c   Djian, Patrick ^d   Heinrichs, Eva Lisa ^e   Huysse, Wouter ^a   Laprell, Heinz ^f   Siebold, Rainer ^g   Verdonk, René ^a  

^a GHENT UNIVERSITY HOSPITAL   (Belgium)

^b CENTRE HOSPITALIER DE VERSAILLES   (France)

^c UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^d Institut de l'appareil locomoteur Nollet   (France)

^e Orteq Limited   (United Kingdom)

^f Lubinus Clinicum Kiel ^*  (Germany)

^g ATOS KLINIK HEIDELBERG   (Germany)

Author keywords

Actifit; biodegradable scaffold; irreparable meniscal defect; meniscal defect; meniscectomy; meniscus; partial meniscectomy; polyurethane scaffold

Indexed keywords

POLYURETHAN; TISSUE SCAFFOLD;

ADOLESCENT; ADULT; ARTICLE; CLINICAL TRIAL; FEMALE; HUMAN; INJURY; KNEE MENISCUS; MALE; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; OUTCOME ASSESSMENT; PAIN; PROSPECTIVE STUDY; SAFETY;

ADOLESCENT; ADULT; FEMALE; HUMANS; MALE; MENISCI, TIBIAL; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PAIN; POLYURETHANES; PROSPECTIVE STUDIES; SAFETY; TISSUE SCAFFOLDS; YOUNG ADULT;

EID: 84859482661     PISSN: 03635465     EISSN: 15523365     Source Type: Journal    
DOI: 10.1177/0363546511433032     Document Type: Article

References (46)

1. Baratz ME, Fu FH, Mengato R. Meniscal tears: the effect of meniscectomy and of repair on intraarticular contact areas and stress in the human knee. A preliminary report. Am J Sports Med. 1986 ; 14 (4). 270-275 (Pubitemid 16077330)
2. Briggs KK, Kocher MS, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am. 2006 ; 88 (4). 698-705
3. Campbell SE, Sanders TG, Morrison WB. MR imaging of meniscal cysts: incidence, location, and clinical significance. AJR Am J Roentgenol. 2001 ; 177 (2). 409-413 (Pubitemid 32660503)
4. Cole BJ, Carter TR, Rodeo SA. Allograft meniscal transplantation: background, techniques, and results. Instr Course Lect. 2003 ; 52: 383-396
5. Cox JS, Nye CE, Schaefer WW, Woodstein IJ. The degenerative effects of partial and total resection of the medial meniscus in dogs' knees. Clin Orthop Relat Res. 1975 ; 109: 178-183
6. Crawford K, Briggs KK, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the IKDC score for meniscus injuries of the knee. Arthroscopy. 2007 ; 23 (8). 839-844 (Pubitemid 47187612)
7. Englund M, Roos EM, Roos HP, Lohmander LS. Patient-relevant outcomes fourteen years after meniscectomy: influence of type of meniscal tear and size of resection. Rheumatology (Oxford). 2001 ; 40: 631-639
8. European Medicines Agency. Points to consider on missing data from the Committee for Proprietary Medicinal Products of the European Medicines Agency (EMEA). Available at: http://www.emea.europa.eu/pdfs/human/ewp/177699EN.pdf. Accessed January 31, 2011.
9. Fetzer GB, Spindler KP, Amendola A, et al. Potential market for new meniscus repair strategies: evaluation of the MOON cohort. J Knee Surg. 2009 ; 22 (3). 180-186
10. Flandry F, Hunt JP, Terry GC, Hughston JC. Analysis of subjective knee complaints using visual analog scales. Am J Sports Med. 1991 ; 19 (2). 112-118
11. Fukubayashi T, Kurosawa H. The contact area and pressure distribution pattern of the knee: a study of normal and osteoarthrotic knee joints. Acta Orthop Scand. 1980 ; 51 (6). 871-879 (Pubitemid 11146058)
12. Ghadially FN, Wedge JH, Lalonde JMA. Experimental methods of repairing injured menisci. J Bone Joint Surg Br. 1986 ; 68 (1). 106-110 (Pubitemid 16156177)
13. Hede A, Larsen E, Sandberg H. The long term outcome of open total and partial meniscectomy related to the quantity and site of the meniscus removed. Int Orthop. 1992 ; 16: 122-125
14. Herman A, Botser IB, Tenenbaum S, Chechick A. Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials. J Bone Joint Surg Am. 2009 ; 91 (9). 2137-2143
15. Higuchi H, Kimura M, Shirakura K, Terauchi M, Takagishi K. Factors affecting long-term results after arthroscopic partial meniscectomy. Clin Orthop Relat Res. 2000 ; 377: 161-168 (Pubitemid 30614881)
16. Hoben GM, Athanasiou KA. Meniscal repair with fibrocartilage engineering. Sports Med Arthrosc. 2006 ; 14 (3). 129-137
17. Höher J, Münster A, Klein J, Eypasch E, Tiling T. Validation and application of a subjective knee questionnaire. Knee Surg Sports Traumatol Arthrosc. 1995 ; 3 (1). 26-33
18. Irrgang JJ, Anderson AF, Boland AL, et al. Responsiveness of the International Knee Documentation Committee subjective knee form. Am J Sports Med. 2006 ; 34 (10). 1567-1573 (Pubitemid 44385848)
19. JacquesLSyrek JensenTSaliveMEO'ConnorDSchaferJ. Coverage decision memorandum for collage meniscus implant (CMI). CAG 00414N, dated 25 May 2010. Available at: http://www4a.cmsgov/medicare-coverage-database/details/ncd- details.aspx?NCDId=337&ncdver=1&NCAId=235&ver=10&NcaName= Collagen+Meniscus+Implant&IsPopup=y&bc=AAAAAAAAIBAA&.
20. Jaureguito JW, Elliot JS, Lietner T, Dixon LB, Reider B. The effects of arthroscopic partial lateral meniscectomy in an otherwise normal knee: a retrospective review of functional, clinical, and radiographic results. Arthroscopy. 1995 ; 11 (1). 29-36
21. Johnson RJ, Kettelkamp DB, Clark W, Leaverton P. Factors affecting late results after meniscectomy. J Bone Joint Surg Am. 1974 ; 56: 719-729
22. Jorgensen U, Sonne-Holm S, Lauridsen F, Rosenklint A. Long-term follow-up of meniscectomy in athletes: a prospective longitudinal study. J Bone Joint Surg Br. 1987 ; 69: 80-83 (Pubitemid 17098515)
23. Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 ; 18 (3). 205-207
24. Kocher MS, Steadman JR, Briggs KK, Sterett WI, Hawkins RJ. Reliability, validity, and responsiveness of the Lysholm knee scale for various chondral disorders of the knee. J Bone Joint Surg Am. 2004 ; 86 (6). 1139-1145 (Pubitemid 38724875)
25. Kurosawa H, Fukubayasi T, Nakajima H. Load-bearing mode of the knee joint: physical behavior of the knee joint with or without menisci. Clin Orthop Relat Res. 1980 ; 149: 283-290 (Pubitemid 10082455)
26. Lysholm J, Gillquist J. Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med. 1982 ; 10 (3). 150-154 (Pubitemid 12014357)
27. McCarty EC, Marx RG, DeHaven KE. Meniscus repair: considerations in treatment and update of clinical results. Clin Orthop Relat Res. 2002 ; 402: 122-134 (Pubitemid 35006584)
28. McDermott ID, Amis AA. The consequences of meniscectomy. J Bone Joint Surg Br. 2006 ; 88 (12). 1549-1556 (Pubitemid 44970679)
29. McNicholas MJ, Rowley DI, McGurty D, et al. Total meniscectomy in adolescence: a thirty-year follow-up. J Bone Joint Surg Br. 2000 ; 82: 217-221 (Pubitemid 30167077)
30. Paxton ES, Stock MV, Brophy RH. Meniscal repair versus partial meniscectomy: a systematic review comparing reoperation rates and clinical outcomes. Arthroscopy. 2011 ; 27 (9). 1275-1288
31. Rodkey WG. Basic biology of the meniscus and response to injury. Instr Course Lect. 2000 ; 49: 189-193
32. Rodkey WG, DeHaven KE, Montgomery WH, et al. Comparison of the collagen meniscus implant with partial meniscectomy: a prospective randomized trial. J Bone Joint Surg Am. 2008 ; 90 (7). 1413-1426 (Pubitemid 351947581)
33. Roos EM, Lohmander LS. The Knee Injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 ; 1: 64
34. Roos EM, Ostenberg A, Roos H, Ekdahl C, Lohmander LS. Long-term outcome of meniscectomy: symptoms, function, and performance tests in patients with or without radiographic osteoarthritis compared to matched controls. Osteoarthritis Cartilage. 2001 ; 9 (4). 316-324 (Pubitemid 32454774)
35. Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS): development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 ; 28 (2). 88-96 (Pubitemid 28366508)
36. Roytman TM, Kitagawa KM, Yamamoto LG. Minimum perceived VAS differences at an interval of 7 days. Pain Clinic. 2006 ; 18 (2). 119-121 (Pubitemid 43844619)
37. Scheller G, Sobau C, Bülow JU. Arthroscopic partial lateral meniscectomy in an otherwise normal knee: clinical, functional, and radiographic results of a long term follow up study. Arthroscopy. 2001 ; 17 (9). 946-952
38. Schimmer RC, Brülhart KB, Duff C, Glinz W. Arthroscopic partial meniscectomy: a 12-year follow-up and two-step evaluation of the long-term course. Arthroscopy. 1998 ; 14 (2). 136-142 (Pubitemid 28196967)
39. Seedhom BB, Dowson D, Wright V. Functions of the menisci: a preliminary study. J Bone Joint Surg Br. 1974 ; 56: 381-382
40. Seedhom BB, Hargreaves DJ. Transmission of the load in the knee joint with special reference to the role of the menisci, part II: experimental results, discussion and conclusions. Eng Med. 1979 ; 8 (4). 220-228 (Pubitemid 10195082)
41. Simpson DA, Thomas NP, Aichroth PM. Open and closed meniscectomy: a comparative analysis. J Bone Joint Surg Br. 1986 ; 68: 301-304 (Pubitemid 16155792)
42. Stein T, Mehling AP, Welsch F, von Eisenhart-Rothe R, Jager A. Long-term outcome after arthroscopic meniscal repair versus arthroscopic partial meniscectomy for traumatic meniscal tears. Am J Sports Med. 2010 ; 38 (8). 1542-1548
43. Verdonk PCM, Van Laer MEE, Verdonk R. Meniscus replacement: from allograft to tissue engineering. Sports Orthop Traumatol. 2008 ; 24 (2). 78-82
44. Verdonk R, Verdonk P, Huysse W, Forsyth R, Heinrichs E-L. Tissue ingrowth after implantation of a novel, biodegradable polyurethane scaffold for treatment of partial meniscal lesions. Am J Sports Med. 2011 ; 39 (4). 774-782
45. Walker PS, Erkman MJ. The role of the menisci in force transmission across the knee. Clin Orthop Relat Res. 1975 ; 109: 184-192
46. Zaffagnini S, Marcheggiani Muccioli GM, Lopomo N, et al. 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. 2011 ; 39 (5). 977-985