Literature DB >> 22723244

Coordinating retrieval and register studies improves postmarket surveillance.

Peter Ellison1, Geir Hallan, Paul Johan Høl, Nils Roar Gjerdet, Leif I Havelin.   

Abstract

BACKGROUND: The relative risk of revision of the Titan(®) femoral stem due to aseptic loosening increased after 2000; however, the reasons for this have not been established. A retrieval analysis was initiated with the aim of delineating the failure mechanism. QUESTIONS/PURPOSES: We asked whether aseptic loosening in stems after 2000 was associated with (1) appearance of osteolytic lesions, (2) wear particle exposure, (3) stem damage, or (4) changes to the implant or surgical instrumentation.
METHODS: Femoral stems, cement, tissue, and radiographs were collected from 28 patients. We assessed the development of osteolytic lesions in 17 patients. Exposure to wear particles was quantified in 18 patients. Stem damage was assessed in 15 patients. We observed differences in the implants by examination of 24 retrieved stems. Information concerning changes to instrumentation was requested from the manufacturer.
RESULTS: We found osteolysis in all patients receiving implants after 2000, which was associated with a median dose of cement and stem particles of 14,726/mm(2). Abrasion covered 59% of the surface of stems implanted from 1999. We identified geometric changes to the stem, the percent weight of aluminum in the stem's oxide layer decreased from 25% to 14% after 1997 and the rasp used to prepare the femoral cavity changed to a broach in 1999.
CONCLUSIONS: Stems implanted from 2000 failed through osteolysis induced by particles released from the cement and implant. Changes to implant geometry, surface oxide layer, and surgical tools occurred in the same time frame as the reduction in survivorship.

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Year:  2012        PMID: 22723244      PMCID: PMC3462873          DOI: 10.1007/s11999-012-2430-4

Source DB:  PubMed          Journal:  Clin Orthop Relat Res        ISSN: 0009-921X            Impact factor:   4.176


  22 in total

Review 1.  The design features of cemented femoral hip implants.

Authors:  T Scheerlinck; P-P Casteleyn
Journal:  J Bone Joint Surg Br       Date:  2006-11

2.  9- to 11-year results of cemented titanium mueller straight stem in total hip arthroplasty.

Authors:  Bernd Baumann; Christian Hendrich; Thomas Barthel; Michael Bockholt; Markus Walther; Jochen Eulert; Christof P Rader
Journal:  Orthopedics       Date:  2007-07       Impact factor: 1.390

3.  Metal wear and tissue response in failed titanium alloy total hip replacements.

Authors:  J D Witt; M Swann
Journal:  J Bone Joint Surg Br       Date:  1991-07

4.  In vitro interface and cement mantle analysis of different femur stem designs.

Authors:  S Gravius; D C Wirtz; C H Siebert; St Andereya; R Mueller-Rath; U Maus; T Mumme
Journal:  J Biomech       Date:  2008-06-02       Impact factor: 2.712

Review 5.  Biological reaction to debris in relation to joint prostheses.

Authors:  P A Revell; N al-Saffar; A Kobayashi
Journal:  Proc Inst Mech Eng H       Date:  1997       Impact factor: 1.617

6.  Tensile strength of the cement-bone interface depends on the amount of bone interdigitated with PMMA cement.

Authors:  K A Mann; D C Ayers; F W Werner; R J Nicoletta; M D Fortino
Journal:  J Biomech       Date:  1997-04       Impact factor: 2.712

7.  Early aseptic loosening of uncemented femoral components in primary total hip replacement. A review based on the Norwegian Arthroplasty Register.

Authors:  L I Havelin; B Espehaug; S E Vollset; L B Engesaeter
Journal:  J Bone Joint Surg Br       Date:  1995-01

8.  A retrieval study of capital hip prostheses with titanium alloy femoral stems.

Authors:  L R Mcgrath; D L Shardlow; E Ingham; M Andrews; J Ivory; M H Stone; J Fisher
Journal:  J Bone Joint Surg Br       Date:  2001-11

9.  A comparative clinical outcome evaluation of smooth (10-13 year results) versus rough surface finish (5-8 year results) in an otherwise identically designed cemented titanium alloy stem.

Authors:  F Hinrichs; M Kuhl; U Boudriot; P Griss
Journal:  Arch Orthop Trauma Surg       Date:  2003-05-13       Impact factor: 3.067

10.  Osteolysis after Charnley primary low-friction arthroplasty. A comparison of two matched paired groups.

Authors:  R P Joshi; N S Eftekhar; D J McMahon; O A Nercessian
Journal:  J Bone Joint Surg Br       Date:  1998-07
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  4 in total

1.  Risk factors for aseptic loosening of Müller-type straight stems: a registry-based analysis of 828 consecutive cases with a minimum follow-up of 16 years.

Authors:  Martin Clauss; Silke Gersbach; Andre Butscher; Thomas Ilchmann
Journal:  Acta Orthop       Date:  2013-06-25       Impact factor: 3.717

2.  Inflammatory tissue reactions around aseptically loose cemented hip prostheses: A retrieval study of the Spectron EF stem with Reflection All-Poly acetabular cup.

Authors:  Susann Wolf; Anne Christine Johannessen; Peter Ellison; Ove Furnes; Geir Hallan; Katharina Rogg; Kathrine Skarstein; Paul Johan Høl
Journal:  J Biomed Mater Res B Appl Biomater       Date:  2022-01-31       Impact factor: 3.405

3.  Practical considerations for volumetric wear analysis of explanted hip arthroplasties.

Authors:  D J Langton; R P Sidaginamale; J P Holland; D Deehan; T J Joyce; A V F Nargol; R D Meek; J K Lord
Journal:  Bone Joint Res       Date:  2014-03-13       Impact factor: 5.853

4.  Early aseptic loosening of a mobile-bearing total knee replacement.

Authors:  Ines Kutzner; Geir Hallan; Paul Johan Høl; Ove Furnes; Øystein Gøthesen; Wender Figved; Peter Ellison
Journal:  Acta Orthop       Date:  2017-11-06       Impact factor: 3.717

  4 in total

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