Graduated introduction of orthopaedic implants: Encouraging innovation and minimizing harm

Journal of Bone and Joint Surgery

Volumn 94, Issue 21, 2012, Pages e158(1)-

  Zywiel, Michael G ^a   Johnson, Aaron J ^b   Mont, Michael A ^b  

^a UNIVERSITY OF TORONTO   (Canada)

^b SINAI HOSPITAL OF BALTIMORE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTHROPLASTY; BIOMEDICAL TECHNOLOGY ASSESSMENT; CLINICAL EFFECTIVENESS; COST; DEVICE APPROVAL; EQUIPMENT DESIGN; ORTHOPEDIC IMPLANT; PRACTICE GUIDELINE; PRIORITY JOURNAL; PRODUCT SAFETY; REVIEW; SURGEON;

EID: 84869106588     PISSN: 00219355     EISSN: 15351386     Source Type: Journal    
DOI: 10.2106/JBJS.K.01675     Document Type: Review

References (42)

1. Crowninshield RD, Rosenberg AG, Sporer SM. Changing demographics of patients with total joint replacement. Clin Orthop Relat Res. 2006 Feb;443:266-72. (Pubitemid 44324955)
2. Green SA. The evolution of medical technology: lessons from the Burgess Shale. Clin Orthop Relat Res. 2001 Apr;(385):260-6. (Pubitemid 32247016)
3. Zahiri CA, Schmalzried TP, Ebramzadeh E, Szuszczewicz ES, Salib D, Kim C, Amstutz HC. Lessons learned from loosening of the McKee-Farrar metal-on-metal total hip replacement. J Arthroplasty. 1999 Apr;14(3):326-32. (Pubitemid 29172249)
4. Treacy RB, McBryde CW, Pynsent PB. Birmingham hip resurfacing arthroplasty. A minimum follow-up of five years. J Bone Joint Surg Br. 2005 Feb;87(2):167-70. (Pubitemid 40282567)
5. Hing CB, Back DL, Bailey M, Young DA, Dalziel RE, Shimmin AJ. The results of primary Birmingham hip resurfacings at a mean of five years. An independent prospective review of the first 230 hips. J Bone Joint Surg Br. 2007 Nov;89(11):1431-8. (Pubitemid 350273235)
6. Pollard TC, Baker RP, Eastaugh-Waring SJ, Bannister GC. Treatment of the young active patient with osteoarthritis of the hip. A five- to seven-year comparison of hybrid total hip arthroplasty and metal-on-metal resurfacing. J Bone Joint Surg Br. 2006 May;88(5):592-600.
7. Carrothers AD, Gilbert RE, Jaiswal A, Richardson JB. Birmingham hip resurfacing: the prevalence of failure. J Bone Joint Surg Br. 2010 Oct;92(10):1344-50.
8. US Food and Drug Administration. Recalls specific to metal-on-metal hip implant systems. Updated 2011 Feb 10. http://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ ucm241770.htm. Accessed 2011 Sep 13.
9. Meier B. A call for a warning system on artificial joints. 2008 Jul 29. http://www.nytimes.com/2008/07/29/health/29iht-29hip.14863139.html?pagewanted= all. Accessed 2012 Aug 1.
10. Meier B, Roberts J. Hip implant complaints surge, even as the dangers are studied. 2011 Aug 22. http://www.nytimes.com/2011/08/23/business/complaints- soar-on-hip-implants-as-dangers-are-studied.html?-r=1&pagewanted=all. Accessed 2012 Aug 1.
11. Smith AJ, Dieppe P, Vernon K, Porter M, Blom AW; National Joint Registry of England and Wales. Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales. Lancet. 2012 Mar 31;379(9822):1199-204. Epub 2012 Mar 13.
12. de Steiger RN, Hang JR, Miller LN, Graves SE, Davidson DC. Five-year results of the ASR XL Acetabular System and the ASR Hip Resurfacing System: an analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am. 2011 Dec 21;93(24):2287-93.
13. Livingston BJ, Chmell MJ, Spector M, Poss R. Complications of total hip arthroplasty associated with the use of an acetabular component with a Hylamer liner. J Bone Joint Surg Am. 1997 Oct;79(10):1529-38. (Pubitemid 27459299)
14. Long WT, Dastane M, Harris MJ, Wan Z, Dorr LD. Failure of the Durom Metasul acetabular component. Clin Orthop Relat Res. 2010 Feb;468(2):400-5. Epub 2009 Sep 2.
15. Morrison TA, Nyce JD, Macaulay WB, Geller JA. Early adverse results with bicompartmental knee arthroplasty: a prospective cohort comparison to total knee arthroplasty. J Arthroplasty. 2011 Sep;26(6 Suppl):35-9. Epub 2011 Jun 24.
16. Palumbo BT, Henderson ER, Edwards PK, Burris RB, Gutiérrez S, Raterman SJ. Initial experience of the Journey-Deuce bicompartmental knee prosthesis: a review of 36 cases. J Arthroplasty. 2011 Sep;26(6 Suppl):40-5. Epub 2011 May 8.
17. Wright TM, Astion DJ, Bansal M, Rimnac CM, Green T, Insall JN, Robinson RP. Failure of carbon fiber-reinforced polyethylene total knee-replacement components. A report of two cases. J Bone Joint Surg Am. 1988 Jul;70(6):926-32.
18. Mahoney OM, Dimon JH 3rd. Unsatisfactory results with a ceramic total hip prosthesis. J Bone Joint Surg Am. 1990 Jun;72(5):663-71. (Pubitemid 20236485)
19. Mendenhall Associates, Inc. Sulzer recalls Inter-Op cups. Orthop Network News. 2001 Jan;12(1):10.
20. Switzerland's Centerpulse: back on its feet. 2002 Jun 20. http://www. economist.com/node/1194309. Accessed 2012 Mar 9.
21. Blumenfeld TJ, Bargar WL. Early aseptic loosening of a modern acetabular component secondary to a change in manufacturing. J Arthroplasty. 2006 Aug;21(5):689-95. (Pubitemid 44108574)
22. Mahomed NN, Syed K, Sledge CB, Brennan TA, Liang MH. Improving the postmarket surveillance of total joint arthroplasty devices. Open Rheumatol J. 2008;2:7-12. Epub 2008 Feb 25.
23. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011 Jun 13;171(11):1006-11. Epub 2011 Feb 14.
24. Sheth U, Nguyen NA, Gaines S, Bhandari M, Mehlman CT, Klein G. New orthopedic devices and the FDA. J Long Term Eff Med Implants. 2009;19(3):173-84.
25. Merck announces voluntary worldwide withdrawal of Vioxx. 2004 Sep 30. http://www.merck.com/newsroom/vioxx/pdf/vioxx-press-release-final.pdf. Accessed 2012 Mar 10.
26. US Food and Drug Administration. Food and Drug Administration 09 June 1999 Trovan (trovafloxacin/alatrofloxacin mesylate) interim recommendations. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053103. htm. Accessed 2012 Mar 10.
27. Pietzsch JB, Aquino LM, Yock PG, Pate-Cornell ME, Linehan JH. Review of U.S. medical device regulation. J Med Device. 2007;1:283-92. (Pubitemid 351795956)
28. Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. Medical devices and the public's health: the FDA 510(k) clearance process at 35 years. Washington, DC: Institute of Medicine of the National Academies; 2011.
29. Callaghan JJ, Crowninshield RD, Greenwald AS, Lieberman JR, Rosenberg AG, Lewallen DG. Symposium: introducing technology into orthopaedic practice. How should it be done? J Bone Joint Surg Am. 2005 May;87(5):1146-58. (Pubitemid 40617588)
30. Noble PC. The impact of marketing strategies on the registry performance of new devices. Read at the Annual Meeting of the American Academy of Orthopaedic Surgeons; 2012 Feb 10; San Francisco, CA. Paper no. 743.
31. Schemitsch EH, Bhandari M, Boden SD, Bourne RB, Bozic KJ, Jacobs JJ, Zdero R. The evidence-based approach in bringing new orthopaedic devices to market. J Bone Joint Surg Am. 2010 Apr;92(4):1030-7.
32. Malchau H. Introducing new technology: a stepwise algorithm. Spine (Phila Pa 1976). 2000 Feb 1;25(3):285.
33. Bohm ER, Dunbar MJ, Bourne R. The Canadian Joint Replacement Registry-what have we learned? Acta Orthop. 2010 Feb;81(1):119-21.
34. Julin J, Jämsen E, Puolakka T, Konttinen YT, Moilanen T. Younger age increases the risk of early prosthesis failure following primary total knee replacement for osteoarthritis. A follow-up study of 32,019 total knee replacements in the Finnish Arthroplasty Register. Acta Orthop. 2010 Aug;81(4):413-9.
35. Paxton EW, Furnes O, Namba RS, Inacio MC, Fenstad AM, Havelin LI. Comparison of the Norwegian knee arthroplasty register and a United States arthroplasty registry. J Bone Joint Surg Am. 2011 Dec 21;93 Suppl 3:20-30.
36. Pedersen AB, Svendsson JE, Johnsen SP, Riis A, Overgaard S. Risk factors for revision due to infection after primary total hip arthroplasty. A population-based study of 80,756 primary procedures in the Danish Hip Arthroplasty Registry. Acta Orthop. 2010 Oct;81(5):542-7.
37. Prime MS, Palmer J, Khan WS. The National Joint Registry of England and Wales. Orthopedics. 2011 Feb;34(2):107-10. doi: 10.3928/01477447-20101221-21.
38. Garellick G, Kärrholm J, Rogmark C, Herberts P. Swedish Hip Arthroplasty Register annual report 2008. Gothenburg: Swedish Hip Arthroplasty Register; 2009.
39. Garellick G, Kärrholm J, Rogmark C, Herberts P. Swedish Hip Arthroplasty Register annual report 2010. Gothenburg: Swedish Hip Arthroplasty Register; 2011.
40. Australian Orthopaedic Association National Joint Replacement Registry. Annual report. Adelaide: AOA; 2007.
41. Dunbar MJ. Cemented femoral fixation: the North Atlantic divide. Orthopedics. 2009 Sep;32(9). pii: orthosupersite.com/view.asp?rID=42832. doi: 10.3928/01477447-20090728-07.
42. Porucznik MA. AJRR completes data collection pilot project. AAOS Now. 2011 Aug;26-7.