CLINICAL ARTICLE

 

Metal-on-metal arthroplasty using the Metasul prosthesis with a minimum ten-year follow-up

 

 

JG Myburgh^I; C Snyckers^II; Z Oschman^III; TMonni^IV

^IMBChB, MMed Orth, FCS(SA)Orth. Department of Orthopaedics, Steve Biko Academic Hospital. University of Pretoria
^IIMBChB, MMed Orth, FCS(SA)Orth. Department of Sports Medicine University of Pretoria
^IIIMBChB, DCH, MSc Sports. Department of Sports Medicine University of Pretoria
^IVMBChB. Department of Orthopaedics, Steve Biko Academic Hospital. University of Pretoria

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ABSTRACT

Despite concern in recent literature about the adverse effects and complications of metal-on-metal total hip replacements, we have obtained excellent results ten to 15 years after metal-on-metal total hip arthroplasty in 11 out of 12 patients (91.66%) that were available for clinical follow-up. We could trace 15 out of a total of 18 patients (88.33%). Three patients died between the nine- and ten-year follow-up. All our available patients were clinically examined using the Harris Hip Score; hip radiographs; ultrasound and blood investigations. Only one patient (8.33%) needed revision surgery. This information can be used to reassure both orthopaedic surgeons and patients who had metal-on-metal total hip arthroplasty performed in the past that not all metal-on-metal total hip replacements need to be revised. We would advise that if patients present with symptoms or signs they should be thoroughly examined clinically and radiologically, and undergo laboratory investigations, before considering revision surgery.

Key words: Hip, arthroplasty, metal on metal, bearing surface, results, adverse effects

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Purpose of the study

Recent literature raised concern about the adverse effects and complications following metal-on-metal bearing surfaces. The following adverse effects were observed in patients with a metal-on-metal articulation, namely: osteol-ysis,^1-3 incidence of pseudotumours,^4,5-11 aseptic lymphocyte proliferation,^4,12,13 groin pain,^14-17 metal allergy^15,18-20 and raised blood and urine chromium (Cr) and cobalt (Co) levels.^21-28 The purpose of this study was to follow up a cohort of patients that received a metal-on-metal total hip replacement with minimum follow-up of ten years and to evaluate them clinically and radiologically, as well as evaluating their blood chromium and cobalt results and to compare our results with the literature.^29-31

 

Methods

A good clinical history was obtained in all available patients that underwent metal-on-metal total hip replacements during 1996 to 2000 using a 28 mm Metasul prosthesis with a minimum follow-up of ten years. They were clinically examined and evaluated with the Harris Hip Score; hip X-rays; full blood count (FBC); C-reactive protein (CRP); liver function tests (LFT); urea, creatinine and electrolytes (U,K & E); blood and urine chromium and cobalt levels and ultrasonic examination of the hip. The ultrasound was done by an independent experienced ultrasonographer in each case to exclude pseudotumours or fluid collections. Out of a total of 18 patients 12 were alive and could be contacted and a good clinical history was obtained. Three of the 18 patients died of natural causes unrelated to their hip prosthesis between 2008 and 2010. They had not needed any revision hip surgery. Another three patients were lost to follow-up. We were able to examine 11 patients clinically and radiologically using the Harris Hip Score, radiographic examinations and ultrasound. The blood and urine chromium and cobalt levels, full blood count, CRP, LFT and U,K & E were also done on these patients. One patient was interviewed telephonically due to the fact that he lives a long distance from our institution. He is still happy with his replaced right hip after 15 years and due to lack of complaints and symptoms he considered it unnecessary to travel to our institution. A primary hip replacement of his opposite hip was done elsewhere two years ago.

The weakness of the study is the small number of patients which does not allow statistical analysis.

 

Results

The average Harris Hip Score was 91.5 (54-100). There were no signs of osteolysis or loosening on radiographic examination in 10 (91.7%) of our patients (Figures 1-4). One patient had radiolucent lines and osteolysis on radiographic examination. The same patient had a 92 mm fluid collection localised lateral and distal to the greater trochanter and a prominent effusion of his hip with an anterior posterior diameter of 22 mm and associated synovitis that was visible on ultrasound. The patient subsequently underwent a revision total hip arthroplasty for component loosening and metalosis. The ultrasonographist could not detect any soft tissue masses or fluid collections in the remaining patients.

 

 

 

 

 

 

 

 

The mean blood Cr level was 1.92 microg/l (<0.5-14.4 microg/l) and the mean blood Co level was 6.66 microg/l (3.0-15.1 microg/l) (Figure 5). The mean urine Cr was 43.3 microg/l (<0.9-447.9 microg/l) and the mean urine Co was12.21 microg/l (<0.8-71.6 microg/l) (Figure 6). The Co/Cr ratio was 4 microg/g (0.8-11.0 microg/g). There was one exception if all the results were compared.

 

 

 

 

Discussion

The development of a locally destructive non-neoplastic mass or 'pseudotumour' is not new and has been reported on since the early history of hip arthroplasty, even with metal-on-polyethylene bearing couplings.³² Unfortunately, due to the accelerated search for improved bearing couplings, product withdrawals due to poor results are also not new to arthroplasty.³³ This often leads to an aggressive and sometimes exaggerated response from surgeons, at times fuelled by medico-legal concerns. The recent concerns raised about metal-on-metal total hip arthroplasty is another such event.^1-20 Although there are currently serious questions being raised as to the validity of metal-on-metal total hip arthroplasty, care should be taken not to include all designs and bearing couplings under the same umbrella. The concept of metal-on-metal failures, pseudotumour development, and metal ion levels is currently a topic of debate and a complete understanding of the complicated biotribological environment is still evasive. As the differential studies indicate, the carbon carbide concentration can have a significant effect on the development of failures.³⁴ Manufacturing techniques can also adversely affect wear particle generation as seen in the early failures with the Birmingham Hip Resurfacing (BHR).³⁵ Serum ion development is also not only seen in the realm of metal-on-metal arthroplasty, as the development of significant serum ion levels have been reported in metal-on-polyethylene total knee arthroplasty.³⁶ Serum ion levels are however higher in metal-on-metal bearing couplings but can show a varying fluctuation that is still not well understood and a universal safe level has not yet been established.^37,38

Local destructive non-neoplastic mass or pseudotumour development is also a complex phenomenon with a seemingly multifactorial aetiology.³⁹ Wear particle generation does however seem to be central in the initiation, development or propagation of Adverse Reaction to Metal Debri (ARMD) or Aseptic Lymphocytic Vasculitis Associated Loosening (ALVAL).⁴⁰ This has led to investigations into inclination angles, anteversion angles and coupling angles.⁴¹ Furthermore, certain design features can increase the development of pseudotumours, as evident in the reduced angle of articulation of the recently withdrawn Articular Surface Replacement (ASR).⁴²

The similarity between ALVAL and a type IV hypersensitivity reaction also points to a complex immunological cascade in the development of pseudotumours.

The question can thus be raised: What about current patients with metal-on-metal total hip arthroplasty?

It is thus clear that our understanding of the complex factors surrounding metal-on-metal total hip arthroplasty is still developing and that a reactionary response to a product recall should be avoided. Not all metal-on-metal bearing couplings have been recalled and many are still functioning well. The current controversies surrounding metal-on-metal bearing couplings limits the present use of this bearing surface and ideally metal-on-metal total hip arthroplasty should be reserved for centres of research.

Although some of the Metasul metal-on-metal bearing couplings have recently shown evidence of failures at 12-year follow-up, good medium-term results have been reported using this bearing coupling.^43,44

In our series investigating patients ten to 15 years after metal-on-metal total hip arthroplasty, we obtained excellent Harris Hip Scores: no signs of prosthetic loosening or peri-prosthetic osteolysis on radiographs and no signs of pseudotumours on ultrasonic examination in 11 (91.66%) patients who were available for follow-up were present. There was no reason for concern when looking at their blood investigations. The exception was a patient who had a revision of the femoral component and a titanium plate following a peri-prosthetic fracture. The acetabular implant was retained. The patient subsequently developed loosening and a pseudotumour. At the second revision it was found that the loose titanium plate caused local tissue damage and reaction. The patient was revised with an uncemented prosthesis with a crosslinked polyethylene liner and a chromium-cobalt femoral head (Figures 7-9).

 

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The remaining patients had excellent Harris Hip Scores and their implants showed no osteolysis or radiological signs of loosening. We advise that patients who had metal-on-metal total hip prostheses should be instructed to visit their orthopaedic surgeon when experiencing any clinical symptoms or signs that may be related to the surgery. If the clinical examination, radiographic examination, serial blood investigations and ultrasound examination are normal and the patient still complains of hip pain, MRI or CT studies may be indicated. Surgeons can reassure patients who had previous metal-on-metal hip replacements that not all of them need revision, but should be followed up on a regular basis and properly investigated if they experience clinical symptoms and signs. We would advise proper clinical, radiological and laboratory examinations prior to any revision surgery. The choice of prosthesis remains difficult and controversial in the active young male patient but metal-on-metal may still be considered as an alternative.²⁹ In female patients less than 40 years of age, metal-on-metal total hip prosthesis should not be considered as they are most likely to develop adverse reactions or loosening according to Glyn-Jones.⁶

 

Conclusion

Despite the recent concern about serious adverse effects and complications, we obtained good-to-excellent results after a minimum ten years' meticulous follow-up in 11 out of 12 patients (91.66%).

This information can be used to reassure both surgeons and patients that had metal-on-metal total hip arthroplasties performed in the past that not all need to be revised. The patients should be followed up on a regular basis and properly investigated if they experience clinical symptoms and signs. We would advise a proper clinical, radiological and laboratory examinations prior to any revision surgery.

We do recommend careful selection of patients, detailed attention to surgical technique, positioning of the prosthesis and close follow-up when considering a metal-on-metal articulation. Patients should be counselled about the possibility of tissue reaction and future revision surgery.

As for the future, the Editors of the SAOJ would like to refer orthopaedic surgeons to the memorandum circulated to all orthopaedic surgeons by our President, Prof TLB le Roux.

The content of this article is the sole work of the authors. No benefits of any form have been derived from any commercial party related directly or indirectly to the subject of this article.

 

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Reprint requests:
Prof JG Myburgh
Department of Orthopaedics
Room 71306, Level 7, Bridge A
Steve Biko Academic Hospital University of Pretoria
Tel:+2712 354 2851
E-mail: hans.myburgh@up.ac.za