메뉴 건너뛰기




Volumn 94, Issue 11, 2012, Pages 979-989

NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: An FDA phase-II prospective, randomized clinical trial after two years

Author keywords

[No Author keywords available]

Indexed keywords

COLLAGEN TYPE 1; TISSUE SCAFFOLD;

EID: 84863594682     PISSN: 00219355     EISSN: 15351386     Source Type: Journal    
DOI: 10.2106/JBJS.K.00533     Document Type: Article
Times cited : (178)

References (46)
  • 2
    • 34948849235 scopus 로고    scopus 로고
    • Clinical practice. Osteoarthritis of the hip
    • Lane NE. Clinical practice. Osteoarthritis of the hip. N Engl J Med. 2007;357:1413-21.
    • (2007) N Engl J Med , vol.357 , pp. 1413-1421
    • Lane, N.E.1
  • 5
    • 18944373370 scopus 로고    scopus 로고
    • Autologous chondrocyte implantation versus matrix-induced autologous chondrocyte implantation for osteochondral defects of the knee. A prospective, randomised study
    • DOI 10.1302/0301-620X.87B5.15905
    • Bartlett W, Skinner JA, Gooding CR, Carrington RW, Flanagan AM, Briggs TW, Bentley G. Autologous chondrocyte implantation versus matrix-induced autologous chondrocyte implantation for osteochondral defects of the knee: a prospective, randomised study. J Bone Joint Surg Br. 2005;87:640-5. (Pubitemid 40711636)
    • (2005) Journal of Bone and Joint Surgery - Series B , vol.87 , Issue.5 , pp. 640-645
    • Bartlett, W.1    Skinner, J.A.2    Gooding, C.R.3    Carrington, R.W.J.4    Flanagan, A.M.5    Briggs, T.W.R.6    Bentley, G.7
  • 8
    • 0034797294 scopus 로고    scopus 로고
    • Autologous chondrocyte implantation for focal chondral defects of the knee
    • Minas T. Autologous chondrocyte implantation for focal chondral defects of the knee. Clin Orthop Relat Res. 2001;391Suppl:S349-61. (Pubitemid 32954038)
    • (2001) Clinical Orthopaedics and Related Research , Issue.391 SUPPL.
    • Minas, T.1
  • 9
    • 79951552828 scopus 로고    scopus 로고
    • Autologous chondrocyte implantation for full thickness articular cartilage defects of the knee
    • CD003323
    • Vasiliadis HS, Wasiak J. Autologous chondrocyte implantation for full thickness articular cartilage defects of the knee. Cochrane Database Syst Rev. 2010;10:CD003323.
    • (2010) Cochrane Database Syst Rev , vol.10
    • Vasiliadis, H.S.1    Wasiak, J.2
  • 14
    • 36249017353 scopus 로고    scopus 로고
    • A second-generation autologous chondrocyte implantation approach to the treatment of focal articular cartilage defects
    • Tuan RS. A second-generation autologous chondrocyte implantation approach to the treatment of focal articular cartilage defects. Arthritis Res Ther. 2007;9:109.
    • (2007) Arthritis Res Ther , vol.9 , pp. 109
    • Tuan, R.S.1
  • 17
    • 57349125838 scopus 로고    scopus 로고
    • Cartilage repair: Third-generation cell-based technologies - Basic science, surgical techniques, clinical outcomes
    • Hettrich CM, Crawford D, Rodeo SA. Cartilage repair: third-generation cell-based technologies - basic science, surgical techniques, clinical outcomes. Sports Med Arthrosc. 2008;16:230-5.
    • (2008) Sports Med Arthrosc , vol.16 , pp. 230-235
    • Hettrich, C.M.1    Crawford, D.2    Rodeo, S.A.3
  • 18
    • 70350043831 scopus 로고    scopus 로고
    • An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: Prospective clinical safety trial at 2 years
    • Crawford DC, Heveran CM, Cannon WD Jr, Foo LF, Potter HG. An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: prospective clinical safety trial at 2 years. Am J Sports Med. 2009;37:1334-43.
    • (2009) Am J Sports Med , vol.37 , pp. 1334-1343
    • Crawford, D.C.1    Heveran, C.M.2    Cannon Jr., W.D.3    Foo, L.F.4    Potter, H.G.5
  • 19
    • 13944283251 scopus 로고    scopus 로고
    • Cartilage restoration, part 2: Techniques, outcomes, and future directions
    • DOI 10.1177/0363546505274578
    • Alford JW, Cole BJ. Cartilage restoration, part 2: techniques, outcomes, and future directions. Am J Sports Med. 2005;33:443-60. (Pubitemid 40270884)
    • (2005) American Journal of Sports Medicine , vol.33 , Issue.3 , pp. 443-460
    • Alford, J.W.1    Cole, B.J.2
  • 20
    • 67651156342 scopus 로고    scopus 로고
    • Surgical management of articular cartilage defects in the knee
    • Cole BJ, Pascual-Garrido C, Grumet RC. Surgical management of articular cartilage defects in the knee. J Bone Joint Surg Am. 2009;91:1778-90.
    • (2009) J Bone Joint Surg Am , vol.91 , pp. 1778-1790
    • Cole, B.J.1    Pascual-Garrido, C.2    Grumet, R.C.3
  • 23
    • 34447269938 scopus 로고    scopus 로고
    • Microfracture: Indications, technique, and results
    • Williams RJ 3rd, Harnly HW. Microfracture: indications, technique, and results. Instr Course Lect. 2007;56:419-28.
    • (2007) Instr Course Lect , vol.56 , pp. 419-428
    • Williams III, R.J.1    Harnly, H.W.2
  • 26
    • 77952715766 scopus 로고    scopus 로고
    • Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects
    • Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010;38:891-902.
    • (2010) Am J Sports Med , vol.38 , pp. 891-902
    • Greco, N.J.1    Anderson, A.F.2    Mann, B.J.3    Cole, B.J.4    Farr, J.5    Nissen, C.W.6    Irrgang, J.J.7
  • 27
    • 80855153536 scopus 로고    scopus 로고
    • ICRS recommendation document: Patient-reported outcome instruments for use in patients with articular cartilage defects
    • Roos EM, Engelhart L, Ranstam J, Anderson AF, Irrgang JJ, Marx RG, Tegner Y, Davis AM. ICRS recommendation document: patient-reported outcome instruments for use in patients with articular cartilage defects. Cartilage. 2011;2:122-36.
    • (2011) Cartilage , vol.2 , pp. 122-136
    • Roos, E.M.1    Engelhart, L.2    Ranstam, J.3    Anderson, A.F.4    Irrgang, J.J.5    Marx, R.G.6    Tegner, Y.7    Davis, A.M.8
  • 28
    • 70349768143 scopus 로고    scopus 로고
    • Validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) for the treatment of focal cartilage lesions
    • Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) for the treatment of focal cartilage lesions. Osteoarthritis Cartilage. 2009;17:1434-9.
    • (2009) Osteoarthritis Cartilage , vol.17 , pp. 1434-1439
    • Bekkers, J.E.1    De Windt, T.S.2    Raijmakers, N.J.3    Dhert, W.J.4    Saris, D.B.5
  • 29
    • 4243144951 scopus 로고    scopus 로고
    • The Knee injury and Osteoarthritis Outcome Score (KOOS): From joint injury to osteoarthritis
    • Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64.
    • (2003) Health Qual Life Outcomes , vol.1 , pp. 64
    • Roos, E.M.1    Lohmander, L.S.2
  • 30
    • 37749015060 scopus 로고    scopus 로고
    • Responder analyses and the assessment of a clinically relevant treatment effect
    • Snapinn SM, Jiang Q. Responder analyses and the assessment of a clinically relevant treatment effect. Trials. 2007;8:31.
    • (2007) Trials , vol.8 , pp. 31
    • Snapinn, S.M.1    Jiang, Q.2
  • 31
    • 70649090039 scopus 로고    scopus 로고
    • Clinical efficacy of the microfracture technique for articular cartilage repair in the knee: An evidence-based systematic analysis
    • Mithoefer K, McAdams T, Williams RJ, Kreuz PC, Mandelbaum BR. Clinical efficacy of the microfracture technique for articular cartilage repair in the knee: an evidence-based systematic analysis. Am J Sports Med. 2009;37:2053-63.
    • (2009) Am J Sports Med , vol.37 , pp. 2053-2063
    • Mithoefer, K.1    McAdams, T.2    Williams, R.J.3    Kreuz, P.C.4    Mandelbaum, B.R.5
  • 32
    • 58149271026 scopus 로고    scopus 로고
    • Arthroscopic second-generation autologous chondrocyte implantation compared with microfracture for chondral lesions of the knee: Prospective nonrandomized study at 5 years
    • Kon E, Gobbi A, Filardo G, Delcogliano M, Zaffagnini S, Marcacci M. Arthroscopic second-generation autologous chondrocyte implantation compared with microfracture for chondral lesions of the knee: prospective nonrandomized study at 5 years. Am J Sports Med. 2009;37:33-41.
    • (2009) Am J Sports Med , vol.37 , pp. 33-41
    • Kon, E.1    Gobbi, A.2    Filardo, G.3    Delcogliano, M.4    Zaffagnini, S.5    Marcacci, M.6
  • 33
    • 77949892536 scopus 로고    scopus 로고
    • Physical activity levels after characterized chondrocyte implantation versus microfracture in the knee and the relationship to objective functional outcome with 2-year follow-up
    • Van Assche D, Van Caspel D, Vanlauwe J, Bellemans J, Saris DB, Luyten FP, Staes F. Physical activity levels after characterized chondrocyte implantation versus microfracture in the knee and the relationship to objective functional outcome with 2-year follow-up. Am J Sports Med. 2009;37 Suppl. 1:42S-49S.
    • (2009) Am J Sports Med , vol.37 , Issue.SUPPL. 1
    • Van Assche, D.1    Van Caspel, D.2    Vanlauwe, J.3    Bellemans, J.4    Saris, D.B.5    Luyten, F.P.6    Staes, F.7
  • 34
    • 77949893602 scopus 로고    scopus 로고
    • Treatment of symptomatic cartilage defects of the knee: Characterized chondrocyte implantation results in better clinical outcome at 36 months in a randomized trial compared to microfracture
    • TIG/ACT/01/2000&EXT Study Group
    • Saris DB, Vanlauwe J, Victor J, Almqvist KF, Verdonk R, Bellemans J, Luyten FP; TIG/ACT/01/2000&EXT Study Group. Treatment of symptomatic cartilage defects of the knee: characterized chondrocyte implantation results in better clinical outcome at 36 months in a randomized trial compared to microfracture. Am J Sports Med. 2009;37 Suppl. 1:10S-19S.
    • (2009) Am J Sports Med , vol.37 , Issue.SUPPL. 1
    • Saris, D.B.1    Vanlauwe, J.2    Victor, J.3    Almqvist, K.F.4    Verdonk, R.5    Bellemans, J.6    Luyten, F.P.7
  • 38
    • 33749343814 scopus 로고    scopus 로고
    • Results after microfracture of full-thickness chondral defects in different compartments in the knee
    • DOI 10.1016/j.joca.2006.05.003, PII S1063458406001506
    • Kreuz PC, Steinwachs MR, Erggelet C, Krause SJ, Knorad G, Uhl M, Südkamp N. Results after microfracture of full-thickness chondral defects in different compartments of the knee. Osteoarthritis Cartilage. 2006;14:1119-25. (Pubitemid 44490314)
    • (2006) Osteoarthritis and Cartilage , vol.14 , Issue.11 , pp. 1119-1125
    • Kreuz, P.C.1    Steinwachs, M.R.2    Erggelet, C.3    Krause, S.J.4    Konrad, G.5    Uhl, M.6    Sudkamp, N.7
  • 39
    • 28744450774 scopus 로고    scopus 로고
    • The use of unequal randomisation ratios in clinical trials: A review
    • DOI 10.1016/j.cct.2005.08.003, PII S1551714405001321
    • Dumville JC, Hahn S, Miles JN, Torgerson DJ. The use of unequal randomisation ratios in clinical trials: a review. Contemp Clin Trials. 2006;27:1-12. (Pubitemid 41758434)
    • (2006) Contemporary Clinical Trials , vol.27 , Issue.1 , pp. 1-12
    • Dumville, J.C.1    Hahn, S.2    Miles, J.N.V.3    Torgerson, D.J.4
  • 40
    • 33646494052 scopus 로고    scopus 로고
    • Use of the cumulative proportion of responders analysis graph to present pain data over a range of cut-off points: Making clinical trial data more understandable
    • Farrar JT, Dworkin RH, Max MB. Use of the cumulative proportion of responders analysis graph to present pain data over a range of cut-off points: making clinical trial data more understandable. J Pain Symptom Manage. 2006;31:369-77.
    • (2006) J Pain Symptom Manage , vol.31 , pp. 369-377
    • Farrar, J.T.1    Dworkin, R.H.2    Max, M.B.3
  • 41
    • 60949088980 scopus 로고    scopus 로고
    • "Responder analysis" for assessing effectiveness of heart failure therapies based on measures of exercise tolerance
    • Burkhoff D, Parides M, Borggrefe M, Abraham WT, Kadish A. "Responder analysis" for assessing effectiveness of heart failure therapies based on measures of exercise tolerance. J Card Fail. 2009;15:108-15.
    • (2009) J Card Fail , vol.15 , pp. 108-115
    • Burkhoff, D.1    Parides, M.2    Borggrefe, M.3    Abraham, W.T.4    Kadish, A.5
  • 42
    • 42749098792 scopus 로고    scopus 로고
    • Guidance for industry: Patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance
    • U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health
    • U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006;4:79.
    • (2006) Health Qual Life Outcomes , vol.4 , pp. 79
  • 43
    • 33746706779 scopus 로고    scopus 로고
    • The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: A randomised non-inferiority trial
    • DOI 10.1016/S0140-6736(06)69155-1, PII S0140673606691551
    • Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, Lackey P, Katlama C, Young B, Yau L, Sutherland-Phillips D, Wannamaker P, Vavro C, Patel L, Yeo J, Shaefer M; KLEAN study team. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006;368:476-82. (Pubitemid 44160731)
    • (2006) Lancet , vol.368 , Issue.9534 , pp. 476-482
    • Eron Jr., J.1    Yeni, P.2    Gathe Jr., J.3    Estrada, V.4    DeJesus, E.5    Staszewski, S.6    Lackey, P.7    Katlama, C.8    Young, B.9    Yau, L.10    Sutherland-Phillips, D.11    Wannamaker, P.12    Vavro, C.13    Patel, L.14    Yeo, J.15    Shaefer, M.16
  • 44
    • 29844440963 scopus 로고    scopus 로고
    • Etanercept and clinical outcomes, fatigue, and depression in psoriasis: Double-blind placebo-controlled randomised phase III trial
    • DOI 10.1016/S0140-6736(05)67763-X, PII S014067360567763X
    • Tyring S, Gottlieb A, Papp K, Gordon K, Leonardi C, Wang A, Lalla D, Woolley M, Jahreis A, Zitnik R, Cella D, Krishnan R. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006;367:29-35. (Pubitemid 43038667)
    • (2006) Lancet , vol.367 , Issue.9504 , pp. 29-35
    • Tyring, S.1    Gottlieb, A.2    Papp, K.3    Gordon, K.4    Leonardi, C.5    Wang, A.6    Lalla, D.7    Woolley, M.8    Jahreis, A.9    Zitnik, R.10    Cella, D.11    Krishnan, R.12
  • 46
    • 33746391045 scopus 로고    scopus 로고
    • Comparison of 4 diets of varying glycemic load on weight loss and cardiovascular risk reduction in overweight and obese young adults: A randomized controlled trial
    • DOI 10.1001/archinte.166.14.1466
    • McMillan-Price J, Petocz P, Atkinson F, O'neill K, Samman S, Steinbeck K, Caterson I, Brand-Miller J. Comparison of 4 diets of varying glycemic load on weight loss and cardiovascular risk reduction in overweight and obese young adults: a randomized controlled trial. Arch Intern Med. 2006;166:1466-75. (Pubitemid 44125865)
    • (2006) Archives of Internal Medicine , vol.166 , Issue.14 , pp. 1466-1475
    • McMillan-Price, J.1    Petocz, P.2    Atkinson, F.3    O'Neill, K.4    Samman, S.5    Steinbeck, K.6    Caterson, I.7    Brand-Miller, J.8


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.