Equally low blood metal ion levels at 10-years follow up of total hip arthroplasties with Oxinium, CoCrMo and stainless steel femoral heads. Data from a randomized clinical trial

Abstract

Background and purpose: The use of inert head materials such as ceramic heads has been proposed as a method of reducing wear and corrosion products from the articulating surfaces in total hip arthroplasty (THA), as well as from the stem-head taper connection. In the present study, we wanted to evaluate the blood metal ion levels of Oxinium modular femoral heads at 10 years postoperatively and compare with the CoCrMo modular femoral head counterpart, and the monoblock stainless steel Charnley prosthesis. Patients and methods: 150 patients with osteoarthritis of the hip joint previously included in a randomized clinical trial that had the primary aim of examining polyethylene wear in cemented THAs were re-grouped according to femoral head material. One group (n=30) had received the Charnley monoblock stainless steel stem with 22.2 mm head (DePuy, UK). The other groups (n=120) received a Spectron EF CoCrMo stem with either a 28 mm CoCrMo or Oxinium modular head (Smith & Nephew, USA). After 10 years, 19 patients had died and 38 withdraw from the study. Five patients were revised due to infection in their hip and 7 were revised due to aseptic loosening of either the cup or stem or both. 81 patients with median age of 79 years (70-91) were available for whole blood metal ion analysis. Results: The levels of Co, Cr, Ni and Zr in the blood were generally low with all head materials (medians <0.3 micrograms/L). We found no statistically significant difference in the concentration of metal ions between the group with Charnley prosthesis (n=17) and those with Spectron EF stems with either CoCrMo (n=32) or Oxinium heads (n=32) (p=0.18-0.81). Interpretation: In this study of patients with non-revised THAs, no indication of severe trunnion corrosion was found. The blood ion levels with the use of ceramic Oxinium modular femoral heads were similar to CoCrMo or stainless steel heads at 10 years follow-up.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT00698672

Funding Statement

The study was supported financially by Western Norway Regional Health Authority, Smith & Nephew Norway and OrtoMedic AS. None of the sources of funding were involved in the planning or analysis of results.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Regional Comittee for Medical Research Ethics Western Norway gave ethical approval for this work (study number REK 2014-02370).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors.

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