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Proc (Bayl Univ Med Cent). Jul 2006; 19(3): 232–238.
PMCID: PMC1484531

Factors to consider in joint prosthesis systems

Abstract

In joint reconstruction, the techniques and materials that provide the best outcomes for patients have been debated. The main points of controversy relate to the use of hemiarthroplasties versus total joint prostheses with metal-on-metal versus metal-on-polyethylene articulations. This article investigates these areas as well as the applicability of the techniques and materials and the complications that can occur. Hypersensitivity to materials used in joint prostheses is relatively common but often unrecognized. Although the discussion applies to all joints, the temporomandibular joint (TMJ) is emphasized. For TMJ reconstruction, metal-on-polyethylene articulation in total joint prostheses provides better treatment outcomes than metal-on-metal articulation.

In reconstruction ofjoints, including the temporomandibular joints (TMJs), the techniques and materials that provide the best outcomes for patients have been debated. The controversies focus on the use of hemiarthroplasties versus total joint prostheses with metal-on-metal versus metal-on-polyethylene articulations.

In reference to TMJ reconstruction, my colleagues and I previously published a prospective study (1) comparing clinical outcomes using the only two TMJ total joint prosthesis systems commercially available and approved by the Food and Drug Administration (FDA) at that time: the Christensen prosthesis (TMJ Implants Inc., Golden, CO) with metal-on-metal articulation (Figure (Figure11) and the TMJ Concepts prosthesis (TMJ Concepts Inc., Ventura, CA) with metal-on-polyethylene articulation (Figure (Figure22). All patients in the study were operated on by the author, and data were collected in the same manner. The results of our study showed that the TMJ Concepts total joint prosthesis with metal on ultra-high-molecular-weight polyethylene (UMWPE) articulation provided statistically significantly better outcomes relative to jaw opening, pain, jaw function, and diet than the Christensen prosthesis with metal-on-metal articulation. This article led to major confrontations between the two camps using the two different prostheses (25). However, comparative clinical studies are essential to determine outcomes using various treatment methods, materials, or devices. Sharing that information with our colleagues is important for our specialties to advance and provide the best-quality treatment for our patients.

Figure 1
The Christensen total joint prosthesis is composed of cast cobalt-chromium-molybdenum alloy providing metal-on-metal articulation. There is one shape for the condyle and a choice of 44 different shapes for the fossa component. These fossa components are ...
Figure 2
The TMJ Concepts custom-fitted total joint prosthesis is composed of a wrought titanium fossa liner covered with a titanium mesh for bone growth at the fossa and for attachment to the ultra-high-molecular-weight polyethylene articular surface. The mandibular ...

TMJ Implants Inc. provides two off-the-shelf products: the Christensen metal fossa-eminence prosthesis for hemiarthroplasty and the Christensen metal-on-metal total joint prosthesis (Figure (Figure1),1), although custom-made total joint devices are also available. TMJ Concepts' custom-fitted prostheses are CAD/ CAM (computer-assisted design/computer-assisted manufacture) devices constructed of metal-on-UMWPE to fit the specific anatomical requirements of each patient (Figure (Figure22).

HEMIARTHROPLASTY

Hemiarthroplasty is the alloplastic covering of one articulating surface within a joint. The Christensen fossa-eminence prosthesis is advertised for use in hemiarthroplasty (3, 6, 7). Dr. Robert Christensen, president of TMJ Implants Inc., claims that his fossa-eminence prosthesis has been used for 42 years in over 12,000 TMJs (3), but in his FDA premarket approval application he cites only two references to support its use (6, 7). Both references are from the nonrefereed TMJournal published by his company, TMJ Implants Inc. One article presented a retrospective review of 18 patients receiving hemiarthroplasty, with reported good results, although 22% of the patients required additional surgery (6).

The second article was written by TMJ Implants Inc. president Dr. Robert Christensen and his staff (7) and presented the company's purported good outcome data on treatment results for hemiarthroplasty and total joint prostheses. These data did not correlate outcomes to specific joint pathology. A major concern is that the number of patients enrolled in the study dramatically decreased with time: 1 year after surgery, 56% of the patients initially enrolled in the study were lost to follow-up; by 2 years, 78% were lost; and by 3 years, almost 90% of the patient population was lost or dropped from the study. Dr. Christensen then used the data from the remaining 10% of the original patient pool and extrapolated the data to represent the outcome for the entire patient pool, claiming high success rates. With the phenomenal loss of study patients, no credible conclusions can be drawn from these data. Yet, the FDA has allowed the Christensen products on the market, despite the Dental Products Panel's unanimous recommendation in 2000 not to approve the fossa-eminence device because of inadequate safety and effectiveness data (8). The FDA required full disclosure labeling of the device's limitations, as well as listing of the availability of nondevice alternative therapies, and then placed the burden of deciding whether or not to use the device—as well as the risk of medical-legal liability—on the doctor and patient. As Daniel Laskin stated in reference to this device, “One can no longer use the issue of FDA approval as an excuse if a device eventually proves to be ineffective” (9).

Three additional retrospective studies have evaluated the use of the Christensen metal fossa-eminence implant for hemiarthroplasty. One paper reported on 34 patients who received this device (10). The follow-up period was 6 to 36 months, with an average of 18 months. Three parameters were evaluated: incisal opening, pain, and diet. If there was an improvement in at least one of these parameters, the outcome was considered a success. Much of the data was obtained by questionnaires sent to the patients. The study showed “considerable improvement” in 73% of the patients, but 18% of the patients later required total joint prostheses. The surgeon in this study recently disclosed that he no longer uses this technique (personal communication, R. Hensher, February 2006).

Another paper reported on 54 patients with 0 to 8 years of follow-up, but 20% of the patients had <1 year of follow-up (11). The pre-and postsurgery data were collected by a subjective questionnaire mailed to the patients after treatment. Patients had to recall their presurgery pain levels and jaw function. Results showed a 56% reduction in pain and a 50% improvement in jaw opening.

Another study evaluated 22 patients treated with the metal fossa-eminence implant while retaining the articular disc and 26 patients in which the articular disc was removed(12). The results for the patients with the articular disc retained are somewhat confusing, as the authors reported that 100% of the patients had decreased pain and 82% had improved jaw function. However, 36% of the patients required further surgery because of increased pain and jaw dysfunction at an average of 13 months after surgery. Among the 26 patients treated with hemiarthroplasty and discectomy so that the condyle functioned directly against the metal fossa, 96% were reported to have decreased pain and increased jaw function. Ten percent of the patients required reoperation. Except for explaining the measurement of the jaw opening, no description was given of the methods of evaluation or data acquisition.

Hemiarthroplasties for hips and shoulders have some success when very specific criteria are met: 1) advanced age; 2) femur or humerus condylar neck fracture; 3) healthy articulating cartilage in the fossa; and 4) limited function of the joint after surgery. However, hemiarthroplasty is not used for other joint problems in the hips and shoulders because of high failure rates (1318). Dr. Christensen advertises the use of his metal fossa-eminence prosthesis as a TMJ hemiarthroplasty for essentially all TMJ pathology, without age limitation, including “internal derangement (perforated, displaced, or damaged meniscus); inflammatory arthritis; trauma; recurrent fibrosis and/or bony ankylosis;previously failed implant surgery;or any other pathology that has been unresponsive to other modalities of treatment” (7). Based on orthopaedic research, the use of the Christensen fossa-eminence device for “all TMJ pathology” is unfounded and unsubstantiated by any appropriate data.

Hemiarthroplasty for hips and shoulders involves function of a cobalt-chromium-molybdenum (CoCrMo) alloy condylar component against the natural fossa (1318) and not a metal fossa against a natural condyle, as used in the Christensen fossa-eminence device. Under normal function, a metal articulation will cause breakdown of the articular cartilage on the natural articulating surface, leading to failure of the hemiarthroplasty, pain, and progression toward revision with a total joint prosthesis (1921). In addition, bone fragments, mineral deposits, and metal debris introduced between the articulating surfaces will accelerate the degeneration of the natural articulating surface (22). If both condylar and fossa articulating components are arthritic, or other degenerative processes are present, then total joint prostheses are recommended for hips, knees, and shoulders (1327).

Knees have two articulating compartments, medial and lateral. Hemiarthroplasty in knees is considered when problems occur in only one compartment. The hemiarthroplasty involves resurfacing either the tibia or femur in the involved compartment; the other healthy compartment is left untouched. Usually, a metal prosthesis is cemented to one articulating surface, or if both articulating surfaces in the same compartment are involved, then a polyethylene cap is added to the opposite articulating surface; metal-on-metal is never used. Patients with knee hemiarthroplasties are significantly limited in their activities because of the high risk of damage to the normal side of the joint. If both the medial and lateral compartments are involved, then a total joint prosthesis of metal-on-UMWPE is indicated (2325) but never a metal-on-metal total joint prosthesis for the knee because of the excessive wear, metal debris, and high failure rate.

TOTAL JOINT PROSTHESES

The basic functional load on a hip total joint prosthesis ranges from 3.5 to 6 times the recipient's body weight; i.e., for a 100-pound person, the functional load is 350 to 600 pounds, and for a 200-pound person, the functional load is 700 to 1200 pounds. For running, jumping, or lifting, the functional load may be 10 times the body weight (28). The maximal functional loading of the TMJ during molar biting is estimated at 265 Newtons (approximately 60 pounds) and during incisor biting is estimated at 160 Newtons (approximately 35 pounds) (29). Dr. Christensen equates the TMJ to the hip joint and condemns TMJ reconstruction with CoCrMo alloy articulating with UMWPE while supporting TMJ metal-on-metal articulation that he bases on research performed with metal-on-metal hip prostheses (3). However, there is a substantial difference in loading between the TMJ and hip joints. This is the primary reason that UMWPE wear debris and related foreign-body giant cell reaction can be associated with hip prostheses but is not seen with the TMJ Concepts metal-on-UMWPE prostheses (30, 31).

The gold standard for articulation materials in hip and knee prostheses is CoCrMo alloy articulating with UMWPE, although metal-on-metal hip prostheses have also been advocated. In hip prostheses, particularization of UMWPE and polymethylmethacrylate, a bone cement, can cause a foreign-body giant cell reaction and bone lyses related to the relatively large size of the particles created by wear (3234). However, metal debris from CoCrMo has been related to osteolysis and loosening of metal-on-metal articulating prostheses (3335).

The first metal-on-metal hip prostheses were placed by Wiles in 1938 using stainless steel as the articulating surfaces. However, the results were not good because of bone resorption and prosthesis loosening from the metal wear debris, so the technique was abandoned. The concept of metal-on-metal joints remained relatively dormant until the 1960s, when renewed interest developed using cast CoCrMo alloy components. However, because of the success of the Charnley metal-on-UMWPE hip prostheses and the continued difficulties associated with metal-on-metal articulations (design problems, loosening of prostheses from metal wear debris, fretting, galling, seizing, and failure), the use of metal-on-metal essentially stopped by the end of the 1960s to early 1970s (32). It wasn't until the late 1980s and early 1990s that interest in metal-on-metal hip prostheses was renewed as a result of significant improvements in materials, design, and manufacturing.

The TMJ Concepts custom-fitted design uses commercially pure titanium for the metal backing in the fossa component that sits against the roof of the fossa and titanium alloy for the mandibular shaft that fits against the mandibular ramus, so that osseointegration occurs with the metal prosthetic components. The joint articulation is between CoCrMo alloy and UMWPE. I am unaware in my patient population (over 275 patients and 500 prostheses) of any loosening of any metal components after surgery. No radiographic or clinical evidence of osteolysis has been identified in the bone structures supporting or surrounding the prostheses as a result of the materials used in the TMJ Concepts prostheses. However, in many of the Christensen TMJ metal-on-metal total joint prostheses requiring revision, metallosis from wear debris is very obvious, and in at least 10% of the revision cases I have done, a crack or fracture of the fossa component has been present. Revision of failed prostheses is indicated for severe pain related to the implant; loose, fractured (Figure (Figure3),3), or displaced components; infection; joint dysfunction; and local and/or systemic reactions to the materials. In the Christensen prosthesis revision cases, the mandibular component is usually well stabilized to the mandibular ramus, but the fossa component is surrounded by a fibrous capsule except at the contact points of articulation with the metal condyle. This interpositional capsule between the device and bony roof of the fossa can allow micromovement that can contribute to failure by screw loosening, increasing metallosis from wear debris, and metal fatigue (Figure (Figure33).

Figure 3
This Christensen total joint prosthesis was removed because of severe increased pain and other localized symptoms. The fossa component had fractured, increasing the production of metallosis and localized symptoms. Fractured metal fragments are seen on ...

METAL HYPERSENSITIVITY AND CELLULAR REACTIONS

Hypersensitivity (allergy) to the metals in joint prostheses has been virtually ignored by clinicians in all specialties. The metals of concern include nickel, cobalt, chromium, molybdenum, titanium, vanadium, and aluminum. The potential dangers are cellular toxicity, carcinogenicity, and hypersensitivity (35). Metal hypersensitivity is a well-established phenomenon (43, 44) and has been associated with adverse reactions to metal implants resulting in premature removal of the devices (36). The majority of reported cases of metal hypersensitivity to CoCrMo alloy or stainless steel have occurred in the hip (36). The most common metal sensitizer in humans is nickel, followed by cobalt and chromium (43, 45), while occasional responses have been reported to titanium and vanadium (36, 46, 47). The percentage of patients with metal hypersensitivity is significantly higher in those with metal-on-metal prostheses than with metal-on-UMWPE (4851) but even higher yet in those with failed metal-on-metal prostheses (36).

Metal ions and particles are released from implants into biological tissues in three ways: dissolution, corrosion, and wear debris. Dissolution involves release of metal atoms or ions from the implants. Contact corrosion occurs with all metals in contact with biological tissues (52, 53). Fretting corrosion occurs between a metal component and an opposing hard surface (i.e., metal, bone, UMWPE). Crevice corrosion occurs in constricted places. Electrolytic(galvanic)corrosion occurs between different metals (35, 36), but importantly, this has not been observed between CoCrMo and titanium alloys in joint prostheses (35, 36, 54). Wear debris is created by articulating surfaces functioning against each other.

Released metal ions or particles can act as small-molecular-weight haptens that bind to proteins or cells and form organometallic complexes, which can become immunogenic antigens or allergens (5557). The immune response begins with the processing of these organometallic complexes by antigen-processing cells, which then present the processed antigen to T helper cells. The T helper cells, in turn, send the antigenic message to either the B cells (to initiate antibody formation; type I hypersensitivity) or to the cytotoxic T cells (to initiate cell-mediated immunity; type IV hypersensitivity) (36, 47, 58). A type I humoral response is less common with metals but occurs when the antibody produced is of the IgE class. Type IV delayed-type hypersensitivity (DTH) cell-mediated responses are common with metals (44, 57) and occur in at least 15% of the population (46, 47, 58). Activated TDTH lymphocytes begin to proliferate and release various cytokines, which result in the accumulation and activation of the macrophages (57). Treatment for patients with significant metal hypersensitivity reactions involves elimination of exposure to the metal ions, usually achieved by removal of the prosthesis.

Hypersensitivity reactions can begin at any age and are more common in females. Induction of hypersensitivity to metals can occur by any of the following means: 1) chronic exposure to low levels of toxic metals; 2) exposure to excessive amounts of metals; 3) acute stressors (i.e., viral and bacterial infections); and 4) psychological trauma (59). Most clinicians are familiar with typical local hypersensitivity reactions including dermatitis, urticaria, and erythema. Additional local symptoms we have observed in patients with confirmed metal hypersensitivity include TMJ pain, myofascial pain, muscle spasms, headaches, earaches, tinnitus, vertigo, and facial swelling. Systemic hypersensitivity reactions may include, but are not limited to, chronic fatigue, depression, mood changes, fibromyalgia, polyarthralgia, pyrexia, immune dysfunction, gastrointestinal problems, hyperexcitability, vasculitis, neurological reactions(central or peripheral), multiple systemic health problems, cardiac instability, end-organ failure, and death (59, 60).

Exposure to a small or large volume of metal in a hypersensitive patient will create an allergic response. However, the larger the volume of ions and particles released, the greater the reaction. Thus, a patient allergic to cobalt and/or chromium will have a greater response to the Christensen metal-on-metal CoCrMo alloy prosthesis because of the sheer size of the device and the associated metal wear debris, creating vastly increased numbers of circulating immunogenic antigens (5557). The TMJ Concepts metal-on-UMWPE prosthesis will produce a much weaker response, since the CoCrMo alloy condyle is comparatively small and the metal wear debris is negligible.

The wear of modern CoCrMo alloy metal-on-metal total hip prostheses causes a metal loss rate 4.5 to 8.5 times greater than the metal loss with CoCrMo alloy-on-UMWPE prostheses (37, 61). Differences in particle size play a major role in the type of localized reaction. Most metal debris particles are small enough (14 μm) to be ingested by individual histiocytes and usually do not stimulate a foreign-body giant cell reaction (34, 62). However, the phagocytosed particles elicit a much greater potential biologic response than UMWPE (63, 64); this can set the stage for a type I or IV hypersensitivity reaction. UMWPE particles can have a greater variance in size. Small particles (<10 μm) are typically contained in mononuclear histiocytes. Larger particles (>10 to 100 μm), the most common, are either contained within or surrounded by giant cells. Very large particles (>100 μm) are much less common and may have associated giant cell involvement or be encapsulated. The immune system cannot digest UMWPE, but the negligible wear debris of the TMJ Concepts prosthesis renders this a nonissue (30, 31). Although metal-on-metal bearings in hip prostheses may produce smaller volumes of wear debris than metal-on-UMWPE, metal-on-metal may produce similar active total surface area of debris. Micromovement or a fractured component will significantly increase the amount of wear debris generated (36). Cellular response may correlate more closely to the total surface area of the debris than the number of particles. Osteolysis, with loosening of metal-on-metal articulations and the associated pain, remains a major concern in orthopaedics (36).

Of greater concern are the potential systemic effects of metal-on-metal articulations. When metal-on-metal is used in young, active patients, the long-term systemic effects are the most potentially troublesome, given the patients' long life expectancies (36). Metal-on-metal articulations produce significant elevations of cobalt (50 times above normal levels) and chromium (100 times above normal levels) in the serum, erythrocytes, and urine, while metal-on-UMWPE produces negligible levels (6567). CoCrMo alloy hemiarthroplasties also produce significantly elevated serum, erythrocyte, and urine levels (47). The long-term systemic effects of this high degree of exposure to cobalt and chromium is unknown. Carcinogenesis is a potential concern, but there may be a latency period of 15 to 35 years between exposure and neoplastic transformation (68). CoCrMo alloy particles have been found to lead to altered phagocytic activity and cell death. Cell death increases with an increasing dosage of particles (69, 70). Cobalt, chromium, and molybdenum particles are toxic, whereas titanium, aluminum, and vanadium particles do not affect cell viability (71). At lower nonlethal doses, metal particles can stimulate macrophages to release various intercellular mediators, proinflammatory and bone-resorbing cytokines (including IL-1, IL-6, tumor necrosis factor alpha, prostaglandin E2), and cobalt-chromium chemokines. UMWPE particles are far less stimulatory for these factors (68, 70, 71). Osteoclastic bone resorption is significantly more extensive in the presence of metal products (72). There may exist a different mechanism of bone loss in response to metallic particles. Although polyethylene particles lead to macrophage recruitment and activation, metallic particles may mediate bone loss through stimulation of osteoclastic activity (7).

CONCLUSIONS

  1. The gold standard for hip, knee, and shoulder prostheses is the metal-on-UMWPE articulation that has been used for 40 years. Metal-on-metal articulations have only shown acceptable success in the hip during the past 10 years, and there are few long-term studies documenting their success. Metal-on-metal is not used for any other joint in orthopaedics.
  2. Hypersensitivity can develop to the metals used in prostheses, with nickel, cobalt, and chromium being the most common metal sensitizers in humans. Hypersensitivity may be a major source of unfavorable outcomes with total joint prostheses. The occurrence of metal hypersensitivity is significantly greater in metal-on-metal articulations than in metal-on-UMWPE articulations.
  3. Metal-on-metal articulations cause significantly increased levels of cobalt and chromium in the body, and the long-term effects are unknown. These metals may cause cellular toxicity, hypersensitivity, and carcinogenicity.
  4. Metal-on-UMWPE has shown negligible wear debris histologically in the TMJ, whereas the Christensen prosthesis often demonstrates visible and histological evidence of metallosis from wear debris.
  5. To appropriately evaluate the success of the Christensen products, independent researchers (not affiliated with TMJ Implants Inc.)must perform prospective studies, because the research data provided by the company are highly suspect.
  6. In our study (1), the TMJ Concepts metal-on-UMWPE total joint prosthesis provided statistically significantly better postsurgical results related to incisal opening, pain, jaw function, and diet compared with the Christensen metal-on-metal total joint prosthesis.

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