The use of highly cross-linked polyethylene in total knee arthroplasty

Polyethylene wear, with resultant particle-induced osteolysis, is a cause of late failure of total knee arthroplasty. The causes of both wear and osteolysis are multifactorial; still, improvements in the polyethylene liner have been investigated. Available highly cross-linked polyethylene tibial liners and patellar prostheses differ greatly in the amount and method of irradiation, thermal treatments, and sterilization techniques they undergo. Several varieties of highly cross-linked polyethylene reduce the gravimetric and volumetric wear of tibial liners in knee simulator studies. However, reduced fracture toughness and the generation of smaller and possibly more reactive particles also have been reported with some varieties of polyethylene. Clinical studies of the use of highly cross-linked polyethylene in total knee arthroplasty are limited. Two nonrandomized trials of highly cross-linked polyethylene in total knee arthroplasty have reported a nonsignificant decrease in radiolucent lines at 2 and 5 years, respectively. The risks of using highly cross-linked polyethylene include fracture of the liner or of a posterior-stabilized tibial post, liner dislodgement or locking mechanism disruption, and possibly more osteolysis. Highly cross-linked polyethylene tibial liners may be considered for younger, more active patients. However, until additional clinical results are available, a cautious approach is warranted to the widespread use of highly cross-linked polyethylene in total knee arthroplasty.     

Chemically Cross‐Linked UHMWPE With Superior Toughness

Radiation cross‐linked ultra‐high‐molecular‐weight polyethylenes (UHMWPEs) are clinically used extensively in total joint arthroplasty due to their high wear resistance. Peroxide cross‐linking of UHMWPE has been proposed to achieve this high level of wear resistance by simultaneously consolidating and cross‐linking in the melt state. High temperature melting of uncross‐linked and cross‐linked UHMWPEs have further shown to improve the toughness. Here, we report on the wear and mechanical properties of a peroxide cross‐linked and high‐temperature melted UHMWPE as a function of vitamin E concentration for oxidative stabilization, peroxide concentration for cross‐linking and high temperature melting temperature for toughness improvement. This method, combining consolidation and cross‐linking in one step, presents an opportunity to manufacture highly wear and oxidation‐resistant joint implant‐bearing surfaces with much improved toughness. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:2182–2188, 2019     

Wear and osteolysis around total knee arthroplasty

Osteolysis induced by wear debris of ultra-high-molecular-weight polyethylene has emerged as a significant problem after total knee arthroplasty. The generation of polyethylene wear and the development of osteolysis around total knee arthroplasty are caused by a combination of patient, implant, and surgical factors. Activity level over time may be the most important patient factor affecting the loads placed on a total knee replacement, but it is the most difficult to manage. Multiple factors related to the manufacturing of the polyethylene implant influence the extent of wear, and surgeons should be cautious in considering enhanced polyethylenes pending results of further investigations. The optimal design of the articular bearing surface remains controversial but needs to be considered with respect to the stresses imparted on component-bone and modular tibial backside interfaces. Surgical factors, including restoration of alignment and ligament balance, are important for long-term durability of the implant. Methods of measuring the wear of total knee implants are still evolving. Thus, when confronted with a worn total knee implant and developing osteolysis, the surgeon should consider each of these factors in selecting the best management option to eliminate the source of debris and minimize the potential for wear and osteolysis following revision.     

Clinical performance of highly cross-linked polyethylenes in total hip arthroplasty

Aseptic loosening secondary to wear-debris-induced osteolysis has been identified as the leading cause of late failure of total hip arthroplasty. Highly cross-linked polyethylene acetabular liners were developed as one approach to reducing this wear. Preclinical laboratory wear testing showed a number of cross-linked polyethylenes to have dramatically less wear than the polyethylene that had been in use for several decades. After the initial bedding-in phase (one to two years), the percent reductions in the wear rate, as indicated by the amount of penetration of the head into the socket evident on serial radiographs, have been comparable with what was predicted from preclinical hip-simulator testing of the highly cross-linked polyethylenes. To our knowledge, there have been no reports of clinically relevant osteolysis that was clearly attributable to wear of a highly cross-linked polyethylene acetabular liner. However, the clinical performance of these materials should be closely monitored with long-term follow-up.     

Aggressive wear testing of a cross-linked polyethylene in total knee arthroplasty

Recently, highly cross-linked polyethylenes with high wear and oxidation resistance have been developed. These materials may improve the in vivo performance of polyethylene components used in total knee arthroplasty. To date, the in vitro knee wear testing of these new polyethylenes has been done under conditions of normal gait. However, their critical assessment also must include aggressive in vitro fatigue and wear testing. In the current study, an aggressive in vitro knee wear and device fatigue model simulating a tight posterior cruciate ligament balance during stair climbing was developed and used to assess the performance of one type of highly cross-linked polyethylene tibial knee insert in comparison with conventional polyethylene. The highly cross-linked inserts and one group of conventional inserts were tested after sterilization. One additional group of conventional inserts was subjected to accelerated aging before testing. The articular surfaces of the inserts were inspected visually for surface delamination, cracking, and pitting at regular intervals during the test. The aged conventional polyethylene inserts showed extensive delamination and cracking as early as 50,000 cycles. In contrast, the unaged conventional and highly cross-linked polyethylene inserts did not show any subsurface cracking or delamination at 0.5 million cycles. The appearance and location of delamination that occurred in the aged conventional inserts tested with the current model previously have been observed in vivo with posterior cruciate-sparing design knee arthroplasties with a tight posterior cruciate ligament.     

The failed total knee arthroplasty: evaluation and etiology

Evaluation of a patient with a failed total knee arthroplasty begins with a detailed history of the index knee arthroplasty and with the patient's medical history. The nature of the complaint after arthroplasty can help determine the etiology of failure. The primary causes of failure of total knee arthroplasty are pain, postoperative stiffness, and instability. Pain associated with weight bearing is most often mechanical and is caused by loosening, component failure, or patellar dysfunction. Continuous pain can be associated with infection or complex regional pain syndrome. Persistent postoperative stiffness may be caused by inadequate rehabilitation or improper balancing of flexion and extension spaces. However, loss of motion after satisfactory mobility has been achieved may be associated with infection, synovitis, tendinitis, or component loosening. Instability after total knee arthroplasty results from improper balancing, inappropriate component size, and component failure. Posterior instability generally occurs during flexion. Medial-lateral instability can result from either improper balancing of components or incompetent collateral ligaments. Radiographs can detect loosening and osteolysis, as well as component wear, fracture, and malposition. Nuclear scans can aid in detecting loosening and infection. If infection is suspected, aspiration is mandatory to attempt to confirm the diagnosis and identify an organism.     

Comparison of cross-linked polyethylene materials for orthopaedic applications

Cross-linked polyethylenes are being marketed by orthopaedic manufacturers to address the problem of osteolysis caused by polyethylene particulate wear debris. Wear testing of these cross-linked polyethylenes in hip simulators has shown dramatic reduction in wear rate compared with standard ultrahigh molecular weight polyethylene, either gamma irradiated in air or nitrogen - or ethylene oxide-sterilized. However, this reduction in wear rate is not without cost. The cross-linking processes can result in materials with lower mechanical properties than standard ultrahigh molecular weight polyethylene. To evaluate the effect of the various cross-linking processes on physical and mechanical properties of ultrahigh molecular weight polyethylene, commercially available cross-linked polyethylenes from six orthopaedic manufacturers were tested. This study was the culmination of collaboration with these manufacturers, who provided cross-linked polyethylene for this study, wear characteristics of the material they provided, and review of the physical and mechanical properties measure for their polyethylene. Cross-linked materials were evaluated as received and after an accelerated aging protocol. Free radical identity and concentration, oxidation, crystallinity, melt temperature, ultimate tensile strength, elongation at break, tensile stress at yield, and toughness are reported for each material. By comparing these physical and mechanical properties, surgeons can evaluate the trade-off that results from developing materials with substantially lower wear rates.     

Role of polyethylene particles in peri-prosthetic osteolysis: A review

There is convincing evidence that particles produced by the wear of joint prostheses are causal in the peri-prosthetic loss of bone, or osteolysis, which, if it progresses, leads to the phenomenon of aseptic loosening. It is important to fully understand the biology of this bone loss because it threatens prosthesis survival, and loosened implants can result in peri-prosthetic fracture, which is disastrous for the patient and presents a difficult surgical scenario. The focus of this review is the bioactivity of polyethylene (PE) particles, since there is evidence that these are major players in the development and progression of osteolysis around prostheses which use PE as the bearing surface. The review describes the biological consequences of interaction of PE particles with macrophages, osteoclasts and cells of the osteoblast lineage, including osteocytes. It explores the possible cellular mechanisms of action of PE and seeks to use the findings to date to propose potential non-surgical treatments for osteolysis. In particular, a non-surgical approach is likely to be applicable to implants containing newer, highly cross-linked PEs (HXLPEs), for which osteolysis seems to occur with much reduced PE wear compared with conventional PEs. The caveat here is that we know little as yet about the bioactivity of HXLPE particles and addressing this constitutes our next challenge.     

Highly Cross-Linked Polyethylene May Not Have an Advantage in Total Knee Arthroplasty

Background

Long-term results after total knee replacement (TKR) with conventional and compression-molded polyethylene (PE) have been excellent. The introduction of highly cross-linked polyethylene (XLPE), which has demonstrated superior wear properties in total hip replacement (THR), has led to its recent use in TKR. However, the knee has a unique biomechanical environment characterized by large contact stresses and shear forces and differs from the highly conforming articulation (and primarily abrasive and adhesive wear) found in THR. For this reason, XLPE, with its decreased fatigue resistance and toughness compared to PE, may not be the best material to withstand these unique forces.

Questions

This review and evaluation of the literature aims to answer the following questions. What are the advantages and disadvantages of XLPE in TKR? Does its success in THR ensure a favorable outcome in TKR? Does the increased cost of XLPE justify its use in TKR?

Methods

A systematic literature review of MEDLINE, Science Direct, and Google Scholar databases was performed searching for advantages and disadvantages of XLPE in TKR. We found 18 biomechanical in vitro investigations and 3 clinical studies comparing conventional and XLPEs. We included levels I through IV published articles in peer-reviewed journals in English language.

Results

Several in vitro studies found XLPE to have significantly better wear properties compared to conventional PE. However, the two clinical investigations that directly compared conventional PE and XLPE found no difference in clinical or radiographic outcomes. Additionally, clinical studies with long-term follow-up on TKR with conventional PE did not find wear-induced osteolysis to be a major cause of failure. Four studies did find cost to be significantly higher for XLPE compared to conventional PE.

Conclusions

Based on our review, we concluded that (1) the material properties of XLPE reduce adhesive and abrasive wear, but not the risk of crack propagation, deformation, pitting, and delamination found in TKR; (2) wear-induced osteolysis in TKR has not been found to be a major cause of failure at long-term follow-up; (3) mid-term follow-up studies show no difference in any recorded outcome measure between conventional PE and XLPE; and (4) XLPE is two to four times the cost of conventional PE without an improvement in clinical or radiographic outcomes. For these reasons, we currently cannot recommend the use of XLPE in TKR. Conventional compression-molded polyethylene with its outstanding long-term results should remain the material of choice in TKR.     

Osteolysis and wear debris after total knee arthroplasty presenting with extra-articular metallosis in the calf

Component wear after total knee arthroplasty (TKA) with extruded metallosis in the extra-articular tissue of the calf secondary to a periprosthetic fracture is a rare complication. A 77-year-old man with a failed Insall-Burstein II TKA prosthesis presented with calf cellulitis after a fall. Radiologic evaluation revealed severe osteolysis and loosening of prosthetic components and an intramuscular abscess communicating with the medullary canal of the tibia through an undisplaced periprosthetic fracture. The patient developed rhabdomyolysis with acute renal failure. Drainage of the calf abscess showed staining of the muscles with wear debris and metallosis. The patient subsequently had debridement and excision of the infected TKA implant. Prompt diagnosis of this condition should be suspected in cases of failed arthroplasty with osteolysis and periprosthetic fracture.     

2009 Knee Society Presidential Guest Lecture: Polyethylene Wear in Total Knees

Knee arthroplasties in young and active patients place a substantial increase in the lifetime tribological demand and potential for wear-induced osteolysis. Polyethylene materials have advanced in recent years, reducing the potential for oxidative degradation and delamination failure. It is timely to consider tribological design variables and their potential to reduce surface wear and the long-term risk of osteolysis. The influence of reduced cross shear in rotating platform mobile-bearing knee designs and reduced surface wear area in low conforming fixed-bearing knees has been investigated. A reduction in cross shear substantially reduced wear in both multidirectional pin-on-plate studies and in rotating platform mobile-bearing designs in knee simulator studies. A reduction in bearing surface contact area substantially reduced surface wear in multidirectional pin-on-plate simulations and in low conforming fixed-bearing knee designs in knee simulator studies. This offers potential for a paradigm shift in knee design predicated by enhanced mechanical properties of new polymer materials. We describe two distinct low-wearing tribological design solutions: (1) a rotating platform design solution with reduced cross shear provides reduced wear with conformity and intrinsic stability; and (2) a low conformity fixed bearing with reduced surface area, provides reduced wear, but has less intrinsic stability and requires good soft tissue function.     

Early aseptic loosening of a total knee arthroplasty due to Gore-Tex particle-induced osteolysis

Anterior cruciate ligament reconstruction with the use of synthetic graft material has been used as an alternative to biologic grafts. The use of these grafts has largely been abandoned in reconstruction of the anterior cruciate ligament because of mechanical failure of the graft and production of wear debris leading to synovitis and recurrent effusions. This article presents a case of early, extensive periprosthetic osteolysis around a total knee arthroplasty associated with wear debris from retained fragments of a Gore-Tex (WL Gore and associates, Inc, Flagstaff, Ariz) (polytetrafluoroethylene) anterior cruciate ligament graft.     

Highly crosslinked vs conventional polyethylene particles: relative in vivo inflammatory response

Crosslinked polyethylenes have been introduced to reduce wear and osteolysis. The osteolysis rate depends on many factors including the biologic activity of the wear particles. This study examines the relative inflammatory potential of highly crosslinked and non-crosslinked polyethylene particles. Polyethylene particles were crosslinked and characterized. Dose-response curves were generated for endotoxin-positive and endotoxin-negative particles at each degree of cross-linking using an in vivo model. The 10-MRad crosslinked polyethylene was more inflammatory than an identical dose (25 mg/mL) of non-crosslinked polyethylene (P = .05). Endotoxin increased the inflammatory response to crosslinked and non-crosslinked polyethylene in a similar fashion. These data suggest that the improved wear characteristics of highly crosslinked polyethylenes may be offset somewhat by the modestly increased inflammatory profile of the highly crosslinked compared with non-crosslinked particles.     

Fracture of the femoral component associated with polyethylene wear and osteolysis after total knee arthroplasty

Fracture of the femoral component associated with polyethylene wear and osteolysis after total knee arthroplasty (TKA) has not been well reported before. A 63-year-old man with osteoarthritis of the right knee underwent TKA with a New Jersey LCS Knee, with cementing on the tibia and patella but not on the femoral component. After 42 months, in addition to wearing of polyethylene of the tibia and patella, severe osteonecrosis of the medial femoral condyle was noted. Osteonecrosis caused loss of osseous support of the medial flange of the femoral component, and the bone ingrowth of the central and lateral flange to the distal femur was so good that it overcame the yield stress of the metal of the femoral component and caused fracture of the femoral component. The osteolytic area was filled with autogenous iliac bone, and a new femoral component was inserted and cemented. The patient's condition became satisfactory with relief of pain. Although uncommon, fracture of the femoral component does occur associated with polyethylene wear and osteolysis.     

How do material properties influence wear and fracture mechanisms?

The wear and fracture mechanisms of ultra-high-molecular-weight polyethylene (UHMWPE) hip and knee implant components are of great interest. The material properties of UHMWPE are affected by ionizing radiation as used for sterilization and cross-linking. Cross-linking with high-dose irradiation has been shown to improve the wear resistance of UHMWPE. However, cross-linking leads to a loss in properties such as ductility and resistance to fatigue crack propagation. Highly cross-linked UHMWPE may be more susceptible than conventional UHMWPE to fracture under severe clinical conditions (eg, impingement). Contemporary hip and knee simulator studies provide good information with which new UHMWPE formulations can be screened for clinical wear performance. However, comparable methodologies are lacking for screening UHMWPEs for fracture resistance. Mechanical tests as well as computational material and structural models should be developed to evaluate the combined effect of material and geometry (structure) on fracture resistance under clinically relevant loading conditions.     

Fracture of the polyethylene tibial post in a posterior cruciate-substituting total knee arthroplasty mimicking patellar clunk syndrome: a report of 5 cases

Fracture of the tibial post in posterior cruciate-substituting total knee arthroplasty has been described in several reports. Additionally, wear of the cam and post mechanism, including polyethylene debris generation and osteolysis of the peri-implant bone stock as been described. Users of a cam and post type posterior stabilized total knee arthroplasty are also familiar with the rare occurrence of the "patellar clunk syndrome," in which suprapatellar fibrous nodular scar tissue becomes entrapped in the intercondylar box of the femoral component as the knee extends from the flexed position and produces a palpable and sometimes audible "clunk." This condition is easily managed with arthroscopic excision of the scar tissue. A small series of 5 patients who presented with symptoms of a patellar clunk syndrome but who in fact had a fracture of the tibial post causing subluxation of the femur on the tibia is presented. The diagnostic characteristics that will help differentiate between the 2 problems is highlighted.     

Continued Improved Wear with an Annealed Highly Cross-linked Polyethylene

Background  

Highly cross-linked polyethylene (HXLPE), created by disrupting the molecular structure of polyethylene, then through the application of heat, encourages creation of new cross-links in the process, resulting in a material with improved wear resistance. The impetuses for this new technology were the unsatisfactory wear properties and subsequent osteolysis of noncross-linked polyethylene. A 72% reduction in wear using highly cross-linked polyethylenes (HXLPE) compared with conventional polyethylene at 5 years was described previously. The longest term followup studies on HXLPE range from 2 to 6 years.     

Periprosthetic fracture of the tibia associated with osteolysis caused by failure of rotating patella in low-contact–stress total knee arthroplasty

Periprosthetic fracture of the tibial plateau associated with osteolysis resulting from mechanical failure of the rotating patellar component after total knee arthroplasty with the New Jersey Low-Contact-Stress (LCS) knee (DePuy, Warsaw, IN) has not been reported previously. A 67-year-old woman with rheumatoid arthritis of the left knee had a LCS prosthesis implanted without cement, using a rotating patellar component. Seven years later, a fracture of the lateral tibial plateau occurred owing to an osteolytic defect with no traumatic accident. The rotating patellar bearing over-rotated and locked; consequently, wear occurred between the patellar metal tray and the femoral component. Immunohistochemistry revealed CD68-positive macrophages in the osteolytic region and phagocytosis of metal particles. The osteolytic region was filled with autogenous bone, and all components were exchanged and cemented. The patient's condition became satisfactory with relief of pain.     

Periprosthetic fracture of the tibia associated with osteolysis caused by failure of rotating patella in low-contact-stress total knee arthroplasty

Periprosthetic fracture of the tibial plateau associated with osteolysis resulting from mechanical failure of the rotating patellar component after total knee arthroplasty with the New Jersey Low-Contact-Stress (LCS) knee (DePuy, Warsaw, IN) has not been reported previously. A 67-year-old woman with rheumatoid arthritis of the left knee had a LCS prosthesis implanted without cement, using a rotating patellar component. Seven years later, a fracture of the lateral tibial plateau occurred owing to an osteolytic defect with no traumatic accident. The rotating patellar bearing over-rotated and locked; consequently, wear occurred between the patellar metal tray and the femoral component. Immunohistochemistry revealed CD68-positive macrophages in the osteolytic region and phagocytosis of metal particles. The osteolytic region was filled with autogenous bone, and all components were exchanged and cemented. The patient's condition became satisfactory with relief of pain.     

Crosslinked polyethylene compared to conventional polyethylene in total hip replacement: Pre-clinical evaluation,in-vitro testing and prospective clinical follow-up study

Background?Polyethylene wear-induced osteolysis is a major cause of implant loosening in total hip arthroplasty. New crosslinked polyethylenes are presumed to give lower wear rates, but no long-term clinical results are available yet.

Patients and methods?We compared basic material characteristics and MTS hip joint simulator wear rates of a crosslinked polyethylene (Duration) to those of conventional polyethylene. In a randomized double-blind 5-year clinical follow-up study, 133 hips (67 conventional, 66 Duration) in 127 patients were followed-up for an average of 5 (3–6) years. Wear rates were measured using a computer-based edge detection method. The radiographic appearances of wear-related phenomena were recorded.

Results?The Duration polyethylene showed a significantly lower in-vitro wear rate in the simulator study (mean 22 (SD 2.3) vs. 40 (SD 1.5) mm3/106 cycles). Also, the in-vivo wear was lower for Duration (mean 0.083 (SD 0.056) mm/year) than for conventional polyethylene (mean 0.123 (SD 0.082) mm/year). All radiographic signs of osteolysis were less frequent in the Duration group.

Interpretation?Our study has given a substantial body of evidence—from lower wear rates, less frequent signs of osteolysis, and higher survival rates after a mean follow-up of 5 years—that Duration provides better clinical outcomes than conventional polyethylene.