Adverse Local Tissue Responses Research Articles

Revision Total Hip Arthroplasty for Aseptically Failed Metal-On-Metal Hip Resurfacing Arthroplasty

BackgroundWhile common, studies assessing outcomes of failed metal-on-metal (MoM) resurfacings converted to total hip arthroplasties (THAs) are limited. We determined the outcomes following revision THA of aseptic MoM hip resurfacings. MethodsBetween 2000 and 2019, we identified 52 revision THAs for failed MoM hip resurfacings through our total joint registry. Mean age was 55 years, 42% were women, and mean body mass index was 28 kg/m2. Adverse local tissue response led to THA in 67% of the cases. The most common revision articulation was metal-on-cross-linked or ceramic-on-cross-linked polyethylene (71%). Median head size was 36 mm. The acetabular component was retained in 21% and 28% used dual-mobility constructs. The mean follow-up was 6 years (range, 2-12 years). ResultsThe 5-year survivorships free of any re-revision or reoperation were 89% and 85%, respectively. The primary cause of re-revision (6) was dislocation (4). The 5-year cumulative probability of dislocation was 19% and was 13% in those patients treated with dual-mobility constructs versus 22% in those treated with standard articulations (P = .58). No dislocations occurred in THAs with retained acetabular components and dual-mobility constructs versus a 5-year cumulative probability of dislocation of 25% in those with revised acetabular components and standard articulations (P = .24). ConclusionRevision THAs for aseptically failed MoM hip resurfacings yielded a 5-year survivorship free of re-revision of 89%. The main reason for failure was dislocation, which was reduced, but not statistically significantly, when a dual-mobility construct was used, especially if the acetabular component was retained. Level of EvidenceIV.

Geometric Variations of Modular Head-Stem Taper Junctions of Total Hip Replacements

Taper degradation in Total Hip Replacements (THR) has been identified as a clinical concern, and the degradation occurring at these interfaces has received increased interest in recent years. Wear and corrosion products produced at the taper junction are associated with adverse local tissue responses, leading to early failure and revision surgery. Retrieval and in-vitro studies have found that variations in taper design affect degradation. However, there is a lack of consistent understanding within the literature of what makes a good taper interface. Previous studies assessed different design variations using their global parameters assuming a perfect cone such as: taper length, cone angle and diameters. This study assessed geometrical variations of as-manufactured head and stem tapers and any local deviations from their geometry. The purpose of this study was to provide a greater insight into possible engagement, a key performance influencing parameter predicted by Morse taper connection theory. This was achieved by taking measurements of twelve different commercially available male tapers and six female tapers using a coordinate measurement machine (CMM). The results suggested that engagement is specific to a particular head-stem couple. This is subject to both their micro-scale deviations, superimposed on their macro-scale differences. Differences in cone angles between female and male tapers from the same manufacturer was found to create a predominately proximal contact. However, distally mismatched couples are present in some metal-on-metal head-stem couples. On a local scale, different deviation patterns were observed from the geometry which appeared to be linked to the manufacturing process. Future work will look at using this measurement methodology to fully characterise an optimal modular taper junction for a THR prosthesis.

Adverse Local Tissue Responses to Failed Temporomandibular Joint Implants

The purpose of this study was to determine whether failed alloplastic temporomandibular joint replacement (TMJR) devices can elicit the aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) reaction seen in some patients with metal-on-metal hip arthroplasties. This study involved analysis of paraffin-embedded sections of peri-implant tissue from failed TMJ implant cases obtained from 3 independent sources. Hematoxylin and eosin staining, conventional and polarized light microscopy, back-scattered electron imaging, and energy-dispersive x-ray analysis were used. Immunohistochemical methods were used to identify T and B lymphocytes and macrophages. The total TMJR device specimens showed primary macrophage and lymphocytic responses similar to responses reported previously for failed total hip implants, including ALVAL. No chronic or acute inflammation was apparent in the failed hemiarthroplasty TMJR cases. In this limited preliminary study, the local tissue responses to the failed TMJR implants showed similar primary macrophage and lymphocyte responses to previously reported failed metal-on-metal and metal-on-polyethylene orthopedic total joint replacement devices. No such local inflammatory responses were seen with the failed TMJR hemiarthroplasty devices.

Revision for taper corrosion at the neck-body junction following total hip arthroplasty: pearls and pitfalls.

The management of the patient with a recalled, modular neck-body total hip arthroplasty can be complex, as it involves a combination of clinical, technical, and medicolegal challenges. Management begins with a thorough history and physical exam, radiographic evaluation, infection workup, and serum metal ion levels. Three-dimensional imaging is obtained based on patient symptomatology and metal ion levels and is used to evaluate for the presence of an adverse local tissue response as well as the integrity of the existing soft tissue envelope. The decision to perform revision surgery is based on a combination of patient symptomatology, laboratory values, and imaging findings. Revision surgery involves the entire armamentarium of femoral revision techniques, and the acetabulum may need to be revised at the surgeon's discretion. The femoral implant can often be removed without disrupting the femoral bone envelope; however, the surgeon should have a low threshold to perform an extended trochanteric osteotomy.

CORR Insights(®): primary ceramic-on-ceramic total hip arthroplasty using a 32-mm ceramic head with a titanium-alloy sleeve.

C eramic-on-ceramic bearings have become a popular alternative to conventional polyethylene in THA. The major advantages of ceramic bearings for THA include their scratch resistance, low coefficient of friction, less-reactive particulate debris, and superior wear resistance. Dating back to the 1970s, ceramic bearing failures were primarily related to aseptic implant loosening and catastrophic ceramic fractures [1]. In the 1990s, a new generation of alumina ceramic bearings became available with higher quality and greater burst strength [3]. They were also mated with implants that had excellent fixation records and high taper tolerances. Despite these advances, ceramic fracture, neck socket impingement, and squeaking remain a current concern. Fracture risk is increased with smaller diameter femoral heads, malpositioned sockets, and the presence of trunnion debris and/or damage. Impingement and squeaking are typically related to implant position, design, and material properties. A more recent concern is the use of larger diameter femoral heads on smaller trunnions. Larger-diameter femoral heads carry a greater risk of fretting corrosion and adverse local tissue responses (ALTRs). Retrievals and in vitro studies [4] have found less fretting corrosion at the head neck junction with ceramic femoral heads compared to metal heads. The addition of a Ti sleeve within the ceramic head decreases the potential risks of fracture from trunnion debris and or damage. However, the metal sleeve raises some concern regarding the potential of fretting corrosion and ALTRs. In the current study, Lim and colleagues reviewed alumina ceramic bearings utilizing a titanium alloy sleeve within the modular ceramic femoral head with a minimum 5-year followup. Currently, clinical studies utilizing alumina ceramic bearings without Ti sleeves have minimum 10-year followup [2, 5]. The principal issues to compare are survivorship revision for any reason, ceramic fracture, and incidence of osteolysis. The authors reported a 97% survivorship for revision for any reason. This is similar to survivorships ranging from 95% to 99% found by others [2, 5]. This CORR Insights is a commentary on the article ‘‘Primary Ceramic-on-Ceramic Total Hip Arthroplasty Using a 32-mm Ceramic Head with a Titanium-alloy Sleeve’’ by Lim and colleagues available at: DOI:10.1007/ s11999-015-4374-y. The author certifies that he, or any member of his immediate family, has no funding or commercial associations (eg, consultancies, stock ownership, equity interest, patent/ licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research editors and board members are on file with the publication and can be viewed on request. The opinions expressed are those of the writers, and do not reflect the opinion or policy of CORR or The Association of Bone and Joint Surgeons. This CORR Insights comment refers to the article available at DOI:10.1007/s11999-0154374-y. J. A. D’Antonio MD (&) Greater Pittsburgh Orthopaedic Associates, 725 Cherrington Parkway, Suite 200, Moon Township, PA 15108, USA e-mail: dantonioja@me.com CORR Insights Published online: 20 June 2015 The Association of Bone and Joint Surgeons1 2015

Novel radiopaque ultrahigh molecular weight polyethylene sublaminar wires in a growth-guidance system for the treatment of early-onset scoliosis: feasibility in a large animal study.

In vivo analysis in an ovine model. To evaluate the feasibility of radiopaque ultrahigh molecular weight polyethylene (UHMWPE) sublaminar wires in a growth-guidance spinal system by assessing stability, biocompatibility, and growth potential. Several growth-guidance systems have been developed for the treatment of early-onset scoliosis. The use of gliding pedicle screws and metal sublaminar wires during these procedures can cause metal-on-metal debris formation and neurological deficits. Novel radiopaque UHMWPE wires are introduced to safely facilitate longitudinal growth and provide stability in a growth-guidance system for early-onset scoliosis. Twelve immature sheep received posterior segmental spinal instrumentation; pedicle screws were inserted at L5 and radiopaque UHMWPE (bismuth trioxide) wires were passed sublaminarly at each level between L3 and T12 and fixed to dual cobalt-chromium rods. Four age-matched animals that were not operated were evaluated to serve as a control group. Radiographs were obtained to measure growth of the instrumented segment. After 24 weeks, the animals were killed and the spines were harvested for histological evaluation and high-resolution peripheral quantitative computed tomographic analysis. No neurological deficits occurred and all instrumentation remained stable. One animal died from an unknown cause. Substantial growth occurred in the instrumented segments (L5-T11) in the intervention group (27 ± 2 mm), which was not significantly different to the control group, (30 ± 4 mm, P = 0.42). High-resolution peripheral quantitative computed tomographic analysis clearly showed safe routing and fixation of the UHMWPE wires and instrumentation. Despite the noted growth, ectopic bone formation with the formation of bony bridges was observed in all animals. Histology revealed no evidence of chronic inflammation or wear debris. This study shows the first results of radiopaque UHMWPE sublaminar wires as part of a growth-guidance spinal system. UHMWPE sublaminar wires facilitated near-normal longitudinal spinal growth. All instrumentation remained stable throughout follow-up; no wire breakage or loosening occurred and no adverse local-tissue response to these wires was observed. N/A.

Pseudotumors After Non-MoM Hip Replacements.

Adverse local tissue response (ALTR) to metal debris associated with hip arthroplasty is presently a hot topic of discussion in the orthopaedic community. Most of the cases reported have involved metal-on-metal (MoM) bearings; consequently, there has been a drive to design devices with alternative bearing surfaces. However, two case reports in the March 2014 editions of JBJS Case Connector and a third from 2012 suggest that ALTR and resulting pseudotumor formation can occur with non-MoM bearings. In the March 12, 2014 JBJS Case Connector , Koper et al. report on a seventy-one-year-old woman who underwent bilateral total hip arthroplasty, with each side incorporating a cobalt-chromium-lined cup and a ceramic head. She experienced two dislocations of the right hip within two years after surgery. Approximately three years postsurgery, she presented with right groin pain and audible crepitation of the right hip. No mass was palpable on physical examination, but CT revealed a solid 8-cm mass in the adductor magnus muscle, and MRI showed an 8.3-cm inhomogeneous lesion in the iliopsoas muscle. A radiograph revealed an estimated acetabular anteversion angle of 38° and an inclination angle of 57°. Serum cobalt and chromium levels were both markedly elevated, while infection parameters were unremarkable. During revision surgery with an uncemented polyethylene-lined cup and a ceramic head, surgeons removed a pseudotumor and aspirated a large amount of dark gray fluid. Light microscopy of the removed tissue revealed a polypoid …

Tapering Our Focus to the Causes and Correction of Metallosis in Primary Total Hip Arthroplasty

Serum metal ion levels associated with primary total hip arthroplasty is a topic of appreciable interest and concern to orthopaedic surgeons. Metal ion levels are elevated in virtually all patients with a total hip implant, but the significance of the elevated metal ions is unclear. Additionally, high serum concentrations of metal ions do not directly correlate with an adverse local tissue response or other adverse response by the host. Patients evaluated in the current investigation had elevated metal ion levels, which the authors believe, and most researchers concur, are primarily associated with corrosion at the femoral head-neck junction1-3. The same group of investigators has recently reported on adverse local tissue response after total hip arthroplasty as a result of metallosis originating from corrosion at the femoral head-neck junction in ten patients who had a metal-on-polyethylene articulation3. The serum cobalt levels …

Adverse Local Tissue Response Lesion of the Knee Associated With Morse Taper Corrosion

Modularity in arthroplasty components has increased options for solving complex issues in primary and revision procedures. However, this technology introduces the risk of accelerated metal ion release as a result of fretting or passive crevice corrosion within the Morse taper junction. Cobalt toxicity locally and systemically has been described with hip metal bearing surfaces and may be accentuated with ion release from Morse tapers. This is a case report of a knee adverse local tissue response lesion associated with corrosion within the Morse taper of a revision knee arthroplasty in the absence of systemic metal allergy.

The Utility of MARS MRI in Patients with Metal-on-Metal Bearings

Metal-on-metal bearings for total hip arthroplasty have a long history of use that dates back to the introduction of the McKee-Farrar prosthesis in the 1960s. Metal-on-metal bearings ultimately fell out of favor because of the excellent clinical results of the Charnley low-friction arthroplasty concept, which employed metal-on-UHMWPE (ultra-high molecular weight polyethylene) bearing surfaces. However, the use of metal-on-metal bearings was revisited in the 1990s as polyethylene-associated periprosthetic osteolysis emerged as a major clinical problem limiting the longevity of hip reconstructions in high-demand patient populations. Within the last decade, numerous metal-on-metal designs for both total hip arthroplasty and hip resurfacing arthroplasty have been introduced into the marketplace. However, over the last several years it has become evident that contemporary metal-on-metal bearings are not immune to some of the problems, including periprosthetic osteolysis, that have plagued other bearing surface combinations. In addition, investigators described a distinct histological pattern, termed “aseptic lymphocyte-dominated vasculitis-associated lesion” (ALVAL), that was associated with symptomatic metal-on-metal bearings. More recently, investigators described local soft-tissue reactions termed “pseudotumors” in association with symptomatic metal-on-metal devices. Initially, studies of adverse local tissue reactions (including osteolysis, ALVAL, and pseudotumors) in retrospective studies of metal-on-metal implants did not indicate the prevalence. However, case-control studies and registries began to document that certain metal-on-metal bearing designs were associated with an unacceptably high failure rate, leading to high-profile device recalls that captured the attention of the worldwide media. In some cases, the adverse local tissue response …

Hemostatic Effectiveness of Fibrin Pad After Partial Nephrectomy in Swine

Current management of severe surgical or traumatic bleeding is often achieved by manual tamponade or occlusion using devices such as tourniquets or ligatures. There are some clinical scenarios where these options are either marginally effective or impractical. The present study evaluates a new combination device (Fibrin pad) consisting of biologically active components (human thrombin and fibrinogen) delivered to the targeted site by an absorbable synthetic matrix (oxidized regenerated cellulose and polyglactin 910) in a swine severe bleeding model. In this model, severe bleeding can be managed by concurrent use of several currently available treatments, or a more convenient option that offers performance and safety advantages. Partial nephrectomies were performed on swine and treated with either Fibrin pad (FP) or conventional therapy (CTR)-temporary occlusion of renal artery, electrocautery, SURGIFLO, EVITHROM, SURGICEL NU-KNIT, and PDS II suture). After intraoperative hemostasis was confirmed, the animals were closed and recovered, then survived for 2, 14, or 56 d. Hemostasis was achieved at surgery and maintained in all FP and CTR treated animals. FP was as effective as CTR at establishing durable hemostasis. Treatment with FP did not require temporary occlusion of the renal artery and decreased the total treatment time by half. No animals in either group had complications related to postoperative bleeding at any time during the study. There was no evidence of pulmonary thrombi or evidence of thrombotic complications. No biologically significant adverse local tissue response was present in association with the Fibrin pad at any study interval, and no biologically relevant or consistent changes in blood parameters were identified. Fibrin pad was as effective as CTR for the primary management of severe bleeding without occlusion of the renal artery and a shorter surgical time. No evidence of a systemic or local adverse response was identified due to exposure to the Fibrin pad.