We report 17 patients (20 hips) in whom metal-on-metal resurfacing had been performed and who presented with various symptoms and a soft-tissue mass which we termed a pseudotumour. Each patient underwent plain radiography and in some, CT, MRI and ultrasonography were also performed. In addition, histological examination of available samples was undertaken. All the patients were women and their presentation was variable. The most common symptom was discomfort in the region of the hip. Other symptoms included spontaneous dislocation, nerve palsy, a noticeable mass or a rash. The common histological features were extensive necrosis and lymphocytic infiltration. To date, 13 of the 20 hips have required revision to a conventional hip replacement. Two are awaiting revision. We estimate that approximately 1% of patients who have a metal-on-metal resurfacing develop a pseudotumour within five years. The cause is unknown and is probably multifactorial. There may be a toxic reaction to an excess of particulate metal wear debris or a hypersensitivity reaction to a normal amount of metal debris. We are concerned that with time the incidence of these pseudotumours may increase. Further investigation is required to define their cause.

Pseudotumours associated with metal-on-metal hip resurfacings

Introduction: We report on a group of 20 metal-onmetal resurfaced hips (17 patients) presenting with a soft tissue mass associated with various symptoms; these masses we termed pseudotumours. Methods: All patients underwent plane radiography; CT, MRI and ultrasound investigations were also performed for some patients. Where samples were available histology was performed. Metal ion levels were measured in six patients and one patient had the metal ion levels in the joint fluid measured. Results: All patients in this series were female. Presentation was variable; the most common symptom was pain or discomfort in the hip region. Other symptoms included spontaneous dislocation, nerve palsy, a noticeable mass or a rash. In all cases a soft tissue mass was present in the region of the hip, this was either solid or cystic. The common histological features were extensive necrosis and lymphocytic infiltration. The blood cobalt and chromium levels varied considerably between the six patients that had these measurements. The median blood chromium level was 3.8 μg/L (range 0.8 to 23 μg/L) and that for cobalt was 11.5 μg/L (range 2.1 to 15 μg/L). The synovial fluid sample taken from a single joint contained much higher metal levels, 701 μg/L for chromium and 329 μg/L for cobalt. Twelve of the 20 cases have so far required revision to a conventional hip replacement. Discussion: This complication is best imaged with ultrasound, and is not detected by normal xray. We estimate that about 1% of patients develop a pseudotumour in the first five postoperative years. The cause of these pseudotumours is unknown and is probably multifactorial, further work is required to define this; they may be manifestations of a metal sensitivity response. We are concerned that with time the incidence of these pseudo-tumours will increase.

Early failure associated with adverse reactions to metal debris is an emerging problem after hip resurfacing but the exact mechanism is unclear. We analysed our entire series of 660 metal-on-metal resurfacings (Articular Surface Replacement (ASR) and Birmingham Hip Resurfacing (BHR)) and large-bearing ASR total hip replacements, to establish associations with metal debris-related failures. Clinical and radiological outcomes, metal ion levels, explant studies and lymphocyte transformation tests were performed. A total of 17 patients (3.4%) were identified (all ASR bearings) with adverse reactions to metal debris, for which revision was required. This group had significantly smaller components, significantly higher acetabular component anteversion, and significantly higher whole concentrations of blood and joint chromium and cobalt ions than asymptomatic patients did (all p < 0.001). Post-revision lymphocyte transformation tests on this group showed no reactivity to chromium or cobalt ions. Explants from these revisions had greater surface wear than retrievals for uncomplicated fractures. The absence of adverse reactions to metal debris in patients with well-positioned implants usually implies high component wear. Surgeons must consider implant design, expected component size and acetabular component positioning in order to reduce early failures when performing large-bearing metal-on-metal hip resurfacing and replacement.

Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: A CONSEQUENCE OF EXCESS WEAR

We examined the relationships between the serum levels of chromium and cobalt ions and the inclination angle of the acetabular component and the level of activity in 214 patients implanted with a metal-on-metal resurfacing hip replacement. Each patient had a single resurfacing and no other metal in their body. All serum measurements were performed at a minimum of one year after operation. The inclination of the acetabular component was considered to be steep if the abduction angle was greater than 55°.

There were significantly higher levels of metal ions in patients with steeply-inclined components (p = 0.002 for chromium, p = 0.003 for cobalt), but no correlation was found between the level of activity and the concentration of metal ions. A highly significant (p < 0.001) correlation with the arc of cover was found. Arcs of cover of less than 10 mm were correlated with a greater risk of high concentrations of serum metal ions. The arc of coverage was also related to the design of the component and to size as well as to the abduction angle of the acetabular component. Steeply-inclined acetabular components, with abduction angles greater than 55°, combined with a small size of component are likely to give rise to higher serum levels of cobalt and chromium ions. This is probably due to a greater risk of edge-loading.

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Correlation between inclination of the acetabular component and metal ion levels in metal-on-metal hip resurfacing replacement

Background
Pseudotumor-like periprosthetic tissue reactions around metal-on-metal (M-M) hip replacements can cause pain and lead to revision surgery. The cause of these reactions is not well understood but could be due to excessive wear, or metal hypersensitivity or an as-yet unknown cause. The tissue features may help distinguish reactions to high wear from those with suspected metal hypersensitivity.

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Histological Features of Pseudotumor-like Tissues From Metal-on-Metal Hips

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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

A method is provided for the manufacture of an implant, in particular of a metallic implant, comprising the steps of roughening the surface of the implant by blasting with blasting particles and of treating the surface with a solvent which selectively dissolves the blasting particles.

Method for the manufacture of an implant, a method for the decontamination of a surface treated with blasting particles and a medical implant

In the method for producing a surface structure, material is ablated by means of a liquid jet ( 1 ). The jet ( 1 ) is emitted from a nozzle ( 10 ) under high pressure (p). In this an ablation location ( 3 ) is controlledly moved on a surface ( 20 a ) of a substrate ( 20 ) to be structured with the production of a predetermined macro-topography ( 2 ′) or a largely planar surface, namely through moving the nozzle and/or the substrate. The substrate is in particular part of a surgical implant. The liquid of the high pressure jet ( 1 ) is emitted at a predetermined diameter d of the nozzle with a sufficiently high pressure p so that through the material ablation a linear track ( 2 ) with quasi-fractal micro-topography ( 4 ) is produced. In this the track width D is at least twice as large as d. Values for p and d are provided in the following range: 100 bar 3000 bar and d>0.03 mm.

Method for producing a surface structure, in particular on a surgical implant

A jet of liquid (1) is discharged from a nozzle (10) at high pressure (p) with a set nozzle diameter (d). The material is worn away leaving a linear trace (2) with quasi-fractal micro-topography. The trace width (D) is at least double the size for d. The liquid used is mainly free of solid particles, especially water suitably prepared preferably. The wear traces produced are locally parallel between which is ridging (22) or a non-linear, especially sinusoidal trace.

Method for manufacturing a surface, in particular on a chirugical implant

of EP1386591Manufacturing (M1) an implant e.g., metallic implant, involves roughening the surface of the implant by blasting with blasting particles, and treating the surface with a solvent which selectively dissolves the blasting particles. Independent claims are included for the following: (1) decontaminating a surface treated with blasting particles, in particular of a metallic implant surface treated with blasting particles; and (2) a medical implant e.g., joint prosthesis, having a surface which is produced by (M1).

Markus Windler

Papers

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

Method for the manufacture of an implant, a method for the decontamination of a surface treated with blasting particles and a medical implant

Method for producing a surface structure, in particular on a surgical implant

Method for manufacturing a surface, in particular on a chirugical implant

Method for manufacturing an implant and method for decontamination of a particle-blasted surface