Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses

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Abstract

Background

Any metal placed in a biological environment undergoes corrosion. Thus, with their large metallic surfaces, TKA implants are particularly prone to corrosion with subsequent release of metal ions into the human body which may cause local and systemic toxic effects and hypersensitivity reactions, and increase cancer risk. To address this problem, a new 7-layer zirconium coating developed especially for cobalt-chrome orthopaedic implants was tested biomechanically and found to lower metal ion release.

The purpose of the proposed clinical trial is to compare the metal ion concentration in patients' plasma before and after implantation of a coated or uncoated TKA implant.

Methods/Design

In this randomised controlled trial, 120 patients undergoing primary TKA will be recruited at the Department of Orthopaedic Surgery of the University Hospital in Dresden, Germany, and randomised to either the coated or uncoated prosthesis. Outcome assessments will be conducted preoperatively and at 3 months, 12 months and 5 years postoperatively. The primary clinical endpoint will be the chromium ion concentration in the patient's plasma after 1 and 5 years. Secondary outcomes include cobalt, molybdenum and nickel ion concentrations after 1 and 5 years, allergy testing for hypersensitivity against one of these metals, the Knee Society Score to assess clinical and physical function of the knee joint, the self-assessment Oxford Score and the Short Form 36 quality of live questionnaire.

Discussion

The metal ion concentration in the patient's plasma has been shown to increase after TKA, its eventual adverse effects being widely debated. In the light of this discussion, ways to reduce metal ion release from orthopaedic implants should be studied in detail. The results of this investigation may lead to a new method to achieve this goal.

Trials register

Clinicaltrials registry NCT00862511

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Most cited references 26

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Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints. A clinical and histomorphological study.

Hans-Georg Willert, Gottfried Buchhorn, Afshin FAYYAZI … (2005)

Some patients who have a total hip replacement with a second-generation metal-on-metal articulation have persistent or early recurrence of preoperative symptoms. Characteristic histological changes in the periprosthetic tissues suggested the development of an immunological response. Therefore, in order to determine the relevance of these symptoms, we performed a study of the clinical data and periprosthetic tissues associated with endoprostheses with a metal-on metal articulation that had been retrieved at revision. Periprosthetic tissues as well as the clinical data on the patients were obtained from the first nineteen consecutive revisions performed at the treating hospitals. At the time of the revision, fourteen patients had the metal-on-metal articulation exchanged for either an alumina-ceramic or a metal-on-polyethylene articulation. Five patients received another second-generation metal-on-metal total joint replacement. Five-micrometer sections were prepared from the tissue samples, were stained with routine and immunohistochemical methods, and were examined histologically. Histological specimens from three groups of patients, two of which were treated with non-metal-on-metal implants, served as controls. The majority of patients had persistence of their preoperative pain or early recurrence of the pain after the original total hip replacement, and often a pronounced hip joint effusion had developed after the original replacement. Radiographic follow-up showed the development of radiolucent lines in five hips and of osteolysis in another seven hips. At the revision surgery, both the cup and the stem were found to be well fixed in nine patients. The characteristic histological features were diffuse and perivascular infiltrates of T and B lymphocytes and plasma cells, high endothelial venules, massive fibrin exudation, accumulation of macrophages with droplike inclusions, and infiltrates of eosinophilic granulocytes and necrosis. Only a few metal particles were detected. Immunohistochemical analysis demonstrated that the cellular reaction was still active. The patients who received another second-generation metal-on-metal articulation at the time of the revision had no decrease in symptoms. In the control group of tissues obtained at revisions of endoprostheses without cobalt, chromium, or nickel articulations, there were no similar signs of immune reactions. These histological findings support the possibility of a lymphocyte-dominated immunological response. Although the prevalence of this reaction is low, the persistence or early reappearance of symptoms, including a marked joint effusion and the development of osteolysis, after primary implantation may suggest the possibility of such a reaction.

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Corrosion of metal orthopaedic implants.

Donald Jacobs, Kimberly R. Urban, J. Gilbert (1998)

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Serum metal ion exposure after total knee arthroplasty.

Frank Krummenauer, Attila Lengel, Matthew J. Ziegler … (2007)

All metal implants release metal ions because of corrosion. This has been studied and debated, especially in metal-on-metal total hip arthroplasties. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. We determined changes in serum levels of metal ions in 41 patients after cemented unconstrained total knee arthroplasty without patellar resurfacing, 18 with unilateral total knee arthroplasty (median, 66 months after surgery) and 23 patients with bilateral total knee arthroplasties (75 and 50 months after first and second surgeries, respectively). Serum concentrations of chromium, cobalt, and molybdenum were analyzed and related to the number of total knee arthroplasties and compared with those of 130 control patients without implants. The median chromium, cobalt, and molybdenum concentrations were 0.92, 3.28, and 2.55 microg/L, respectively, in the unilateral total knee arthroplasty sample and 0.98, 4.28, and 2.40 microg/L, respectively, in the bilateral total knee arthroplasty sample. We observed no difference between the serum levels in patients with unilateral and bilateral arthroplasties, but the serum levels of chromium and cobalt of both study groups were greater than those of the control group (less than 0.25 microg/L). The patients who had total knee arthroplasty had molybdenum profiles that were similar to those of the control group (median, 2.11 microg/L).

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Author and article information

Journal

Journal ID (nlm-ta): BMC Musculoskelet Disord

Title: BMC Musculoskeletal Disorders

Publisher: BioMed Central

ISSN (Electronic): 1471-2474

Publication date Collection: 2009

Publication date (Electronic): 14 October 2009

Volume: 10

Page: 128

Affiliations

[1 ]Department of Orthopaedic Surgery, University Hospital Carl Gustav Carus, Medical Faculty of the Technical University of Dresden, Germany

[2 ]Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Carl Gustav Carus, Medical Faculty of the Technical University of Dresden, Germany

Article

Publisher ID: 1471-2474-10-128

DOI: 10.1186/1471-2474-10-128

PMC ID: 2766373

PubMed ID: 19828019

SO-VID: 7fc8fdb1-966c-4f72-be0c-c1db9971503d

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses

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Abstract

Background

Methods/Design

Discussion

Trials register

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Orthopedics

Most cited references 26

Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints. A clinical and histomorphological study.

Corrosion of metal orthopaedic implants.

Serum metal ion exposure after total knee arthroplasty.

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