Initial load-to-failure and failure analysis in single- and double-row repair techniques for rotator cuff repair.

AIM: This experimental study aimed to compare the load-to-failure rate and stiffness of single- versus double-row suture techniques for repairing rotator cuff lesions using two different suture materials. Additionally, the mode of failure of each repair was evaluated. METHOD: In 32 sheep shoulders, a standardized tear of the infraspinatus tendon was created. Then, n = 8 specimen were randomized to four repair methods: (1) Double-row Anchor Ethibond coupled with polyester sutures, USP No. 2; (2) Double-Row Anchor HiFi with polyblend polyethylene sutures, USP No. 2; (3) Single-Row Anchor Ethibond coupled with braided polyester sutures, USP No. 2; and (4) Single-Row Anchor HiFi with braided polyblend polyethylene sutures, USP No. 2. Arthroscopic Mason-Allen stitches were placed (single-row) and combined with medial horizontal mattress stitches (double-row). All specimens were loaded to failure at a constant displacement rate on a material testing machine. RESULTS: Group 4 showed lowest load-to-failure result with 155.7 +/- 31.1 N compared to group 1 (293.4 +/- 16.1 N) and group 2 (397.7 +/- 7.4 N) (P < 0.001). Stiffness was highest in group 2 (162 +/- 7.3 N/mm) and lowest in group 4 (84.4 +/- 19.9 mm) (P < 0.001). In group 4, the main cause of failure was due to the suture cutting through the tendon (n = 6), a failure case observed in only n = 1 specimen in group 2 (P < 0.001). CONCLUSIONS: A double-row technique combined with arthroscopic Mason-Allen/horizontal mattress stitches provides high initial failure strength and may minimize the risk of the polyethylene sutures cutting through the tendon in rotator cuff repair when a single load force is used.

Phagocytosis of wear debris by osteoblasts affects differentiation and local factor production in a manner dependent on particle composition.

Wear debris is considered to be one of the main factors responsible for aseptic loosening of orthopaedic endoprostheses. Whereas the response of cells in the monocytic lineage to foreign materials has been extensively studied, little is known about cells at the bone formation site. In the present study, we examined the hypothesis that the response of osteoblasts to wear debris depends on the chemical composition of the particles. We produced particles from commercially pure titanium (cpTi), Ti-6Al-4V (Ti-A), and cobalt-chrome (CoCr) and obtained ultrahigh molecular weight polyethylene (UHMWPE; GUR 4150) particles from a commercial source. The equivalent circle diameters of the particles were comparable: 1.0 +/- 0.96 microm for UHMWPE; 0.84 +/- 0.12 microm for cpTi; 1.35 +/- 0.09 microm for Ti-A, and 1.21 +/- 0.16 microm for CoCr. Confluent primary human osteoblasts and MG63 osteoblast-like cells were incubated in the presence of particles for 24 h. Harvested cultures were examined by transmission electron microscopy to determine if the cells had phagocytosed the particles. Particles were found intracellularly, primarily in the cytosol, in both the primary osteoblasts and MG63 cells. The chemical composition of the particles inside the cells was confirmed by energy-dispersive X-ray analysis. Morphologically, both cell types had extensive ruffled cell membranes, less-developed endoplasmic reticulum, swollen mitochondria, and vacuolic inclusions compared with untreated cells. CpTi, Ti-A, and CoCr particles were also added to cultures of MG63 cells to assess their effect on proliferation (cell number) and differentiation (alkaline phosphatase activity), and PGE2 production. All three types of particles had effects on the cells. The effect on cell number was dependent on the chemical composition of the particles; Ti-A and CoCr caused a dose-dependent increase, while cpTi particles had a biphasic effect with a maximal increase in cell number observed at the 1:10 dilution. Alkaline phosphatase specific activity was also affected and cpTi was more inhibitory than Ti-A or CoCr. PGE2 production was increased by all particles, but the magnitude of the effect was particle-dependent: CoCr > cpTi > Ti-A. This study demonstrates clearly that human osteoblast-like cells and MG63 cells can phagocytose small UHMWPE, CoCr, Ti-A, and cpTi particles. Phagocytosis of the particles is correlated with changes in morphology, and analysis of MG63 response shows that cell proliferation, differentiation, and prostanoid production are affected. This may have negative effects on bone formation adjacent to an orthopaedic implant and may initiate or contribute to the cellular events that cause aseptic loosening by inhibiting bone formation. The effects on alkaline phosphatase and PGE2 release are dependent on the chemical composition of the particles, suggesting that both the type and concentration of wear debris at an implant site may be important in determining clinical outcome.

In vitro toxicity and mutagenicity of CoCrMo and Ti6Al wear particles.

Contact of wear particles with body fluids can result in widespread dissemination of extractable constituents from joint implants. The aim of this in vitro study is to clarify whether there is a mutagenic and/or carcinogenic risk from CoCrMo and Ti6Al wear particles. Particles of a representative size were produced by fretting; toxicity and mutagenicity were investigated using the salmonella/microsome test according to AMES and the V79-HGPRT Test (Chinese Hamster Fibroblasts). To obtain the greatest possible elution of all constituents the metallic wear particles were extracted with dimethylsulfoxyd and water and the resulting eluates mixed together. Neither the bacterial assay nor the mammalian cell system after repeated test series under standardised conditions produced evidence of a toxic or mutagenic effect in the concentration range under study. It is therefore not to be expected that CoCrMo or Ti6Al alloys initiate carcinogenesis in the human organism.

Influence of orthopedic particulate biomaterials on inflammation and synovial microcirculation in the murine knee joint.

The purpose of the present study was to examine changes in the synovial microcirculation as well as synovial tissue responses to exposure to titanium, polymethylmethacrylate (PMMA), ceramic (Al(2)O(3)), cobalt-chromium alloy (Co-Cr), and polyethylene (PE) particles in an in vivo model. The particulate biomaterials were injected into the left knee joint of female Balb/c mice and assessment of the synovial microcirculation using intravital fluorescence microscopy as well as histological evaluation of the synovial tissue response were performed on day 7 after particle administration. Intravital microscopic measurements revealed that all tested biomaterials caused significantly (p < 0.05) enhanced leukocyte-endothelial cell interactions and an increase of functional capillary density compared to controls. In the histological examination PMMA, Al(2)O(3), PE, and Co-Cr particles provoked significantly (p < 0.05) enhanced inflammatory tissue responses in comparison to tissue from control animals. Titanium particles showed significantly (p < 0.05) less leukocyte-endothelial cell interactions than the other particulate biomaterials and caused significantly (p < 0.05) minor membrane thickening compared to PE and PMMA particles. In conclusion, all tested particulate biomaterials were capable of inducing inflammatory responses in the present study. Our data suggest that titanium particles may cause less leukocyte activation and inflammatory tissue responses than other particulate biomaterials used in total joint arthroplasty.

Osseointegration of cemented and noncemented implants in artificial hip replacement: long-term findings in man.

Implant fixation is of utmost importance for pain-free function of endoprostheses. Primary fixation is achieved during implantation, whereas secondary fixation is a result of repair and bone remodelling during the healing process comparable to fracture healing. The chronologic course of the healing process follows three overlapping phases: (i) an initial phase with destruction and necroses of bone, (ii) a phase of repair with integration of the implant into the bone, and (iii) a phase of stabilization of the permanent implant bed with adaptation to load transfer and possible reactions to irritations of the interface like sepsis, mechanical instability, corrosion and degradation of implant materials, and wear products from articulating and anchoring surfaces.

[Exposure of surgical/orthopedic operating room personnel to monomer vapors during the use of bone cements--review of the literature and report of experiences]. / Exposition des chirurgischen/orthopädischen OP-Personals durch Monomer-Dämpfe bei der Anwendung von Knochenzementen--Literaturstudie und Erfahrungsbericht.

PMMA bone cements are used for the fixation of artificial joint replacements. During their application in the operating theater, a small amount of the monomer evaporates. Operating room staff and surgeons are often not adequately informed about the negative properties and the effects on health of these vapours. Basic information about monomers and their toxicity, and safety regulations have been compiled. On the basis of present knowledge, the authors do not regard the repeated use of bone cement throughout the course of a day to represent a hazard to health.

Biomechanical characteristics of single-row repair in comparison to double-row repair with consideration of the suture configuration and suture material.

The aim of the study was to evaluate the time zero mechanical properties of single- versus double-row configuration for rotator cuff repair in an animal model with consideration of the stitch technique and suture material. Thirty-two fresh-frozen sheep shoulders were randomly assigned to four repair groups: suture anchor single-row repair coupled with (1) braided, nonabsorbable polyester suture sized USP No. 2 (SRAE) or (2) braided polyblend polyethylene suture sized No. 2 (SRAH). The double-row repair was coupled with (3) USP No. 2 (DRAE) or (4) braided polyblend polyethylene suture No. 2 (DRAH). Arthroscopic Mason-Allen stitches were used (single-row) and combined with medial horizontal mattress stitches (double-row). Shoulders were cyclically loaded from 10 to 180 N. Displacement to gap formation of 5- and 10-mm at the repair site, cycles to failure, and the mode of failure were determined. The ultimate tensile strength was verified in specimens that resisted to 3,000 cycles. DRAE and DRAH had a lower frequency of 5- (P = 0.135) and 10-mm gap formation (P = 0.135). All DRAE and DRAH resisted 3,000 cycles while only three SRAE and one SRAH resisted 3,000 cycles (P < 0.001). The ultimate tensile strength in double-row specimens was significantly higher than in others (P < 0.001). There was no significant variation in using different suture material (P > 0.05). Double-row suture anchor repair with arthroscopic Mason-Allen/medial mattress stitches provides initial strength superior to single-row repair with arthroscopic Mason-Allen stitches under isometric cyclic loading as well as under ultimate loading conditions. Our results support the concept of double-row fixation with arthroscopic Mason-Allen/medial mattress stitches in rotator cuff tears with improvement of initial fixation strength and ultimate tensile load. Use of new polyblend polyethylene suture material seems not to increase the initial biomechanical aspects of the repair construct.

Endoscopy of the femoral canal in revision arthroplasty of the hip.A new method for improving the operative technique and analysis of implant failure.

Femoral endoscopy using a special endoscope was performed in 28 revision arthroplasties with the aim of improving the operative technique and to analyze implant failure. Before clinical application, the method was used to analyze the implant bed in clinically and radiographically well-fixed prostheses in autopsy cases without implant failure. Initially, it was performed on 4 experimental implantations of newly designed revision devices into cadaver femurs to obtain additional information concerning the design rationale of implants and instruments for revision surgery. During revision surgery, the new endoscope showed that controlled removal of the cement and granulomatous tissue was possible while avoiding cortical windows or transfemoral approaches. Under visual control, preparation of the new implant bed was less hazardous and more efficient, resulting in good preservation of bone stock and reduced exposure to X-rays. Analysis of the implant bed in failed hip endoprostheses revealed cracks or fractures of the cement mantle in 21 of 23 cemented components. There were two different types of cracks: longitudinal and transverse, which were mostly connected and invisible to X-ray analysis. Cement defects, thin cement mantles, or the proximal border of the cement mantle were found to be places where cracks originated. Granulomatous tissue was noted to protrude into the cement fissures and cracks. In autopsy cases, cement cracks were also found in clinically asymptomatic and radiographically well-fixed prostheses. These cracks were observed to be mainly oriented in the longitudinal direction, similar to those seen in the revision cases. Early signs of debonding became obvious even without lesions in the cement mantle. In experimental implantations of newly designed stems, the efficacy of the different instruments and the fit of the implant could be evaluated by endoscopic control inside the intramedullary canal. Further, it was possible to directly visualize the shape and condition of the primary implant bed after removal of the implant. Femoral endoscopy improved the surgical technique in revision arthroplasty. In addition, it is a very useful tool for the analysis of the implant bed in clinical and autopsy cases as well as in experimental implantations.

[The significance of wear and material fatigue in loosening of hip prostheses]. / Die Bedeutung von Abrieb und Materialermüdung bei der Prothesenlockerung an der Hüfte.

Particles created by wear and disintegration of implant materials give rise to foreign body reactions in the tissue surrounding joint endoprostheses. Histiocytes and foreign body giant cells phagocytize the particles released and form granulomas, which lead in turn to remodelling and resorption of the bone at the interface between implant and bone. As a consequence of this, osteolysis develops, which may lead to loosening and complete failure of fixation of the implant. Radiographically, the areas of osteolysis appear as localized, round, oval or oblong scalloping defects or as radiolucent lines in the endosteal sections of the bone immediately adjacent to the implants. This paper reports on 21 hip joint endoprostheses in which polyethylene and bone cement particles induced large areas of osteolysis at the bone/cement interface. In 8 cases the polyethylene particles originated from the convex joint surfaces of ball heads in "soft-top" endoprostheses (with or without simultaneous replacement of the acetabulum by a metal cup), and in 5 cases they originated from the anchoring surfaces of non-cemented cone-shaped screw-in sockets (Endler type); osteolysis and loosening of these endoprostheses appeared on average 48.2 and 76.6 months after implantation, respectively. The bone cement fragments came from the bone cement mantle of the femur, which had become fractured, disrupted and crushed, in 8 cases of total hip replacement with cemented prostheses; osteolysis appeared on average 87 months after primary implantation in these cases. Tissue samples taken at revision surgery from the joint capsule, the bone/cement interface and the osteolytic areas were processed into histological sections for microscopy and examined in the usual way. The type and amount of phagocytized material were subjected to semiquantitative analysis. We were able to show that osteolysis at the bone/cement interface can be induced by foreign body reactions to abraded polyethylene particles alone as well as by reactions to fragmented bone cement. The morphology of the tissue reaction to particles of the different materials is quite similar. The effect of the foreign body granulomas depends less on the type of the polymer than on the amount of abrasion and fragmentation products released into the surrounding tissue. This again proves that the life-time of joint endoprostheses depends essentially on factors influencing the wear rate. Polymer materials, with low wear resistance, are unsuitable for convex joint surfaces and for direct fixation to bone.(ABSTRACT TRUNCATED AT 400 WORDS)

Osteolysis in alloarthroplasty of the hip. The role of bone cement fragmentation.

Movement at the interface between bone and cement and fractures of the cement can cause fragmentation of the polymethylmethacrylate (PMMA) bone cement implant. In order to obtain further information about the effect of PMMA fragments on the surrounding tissue and the role of such particles in the development of bone resorption, the authors investigated 17 patients with cemented total hip endoprostheses showing osteolysis and implant loosening in the femoral shaft with (Group B) and without (Group A) involvement of the acetabulum. The roentgenographic follow-up examinations revealed an initially slow and later more rapid extension of the endosteal bone erosions, with a predilection for the tip of the stem, the lesser trochanter, and laterally for the middle of the stem. At revision surgery, tissue samples were taken from the joint capsule and the bone-cement interface, in particular from the osteolysis in the femoral shaft and the acetabulum. The tissue samples were processed for histology, microscopically examined, and semiquantitatively evaluated. The retrieved devices were also carefully inspected. Large foreign-body granulomas were found at the bone-cement interface and in the joint capsule. Histiocytes and foreign-body giant cells stored particles of PMMA and polyethylene, of which fragmented bone cement predominated. Granulomatous tissue invaded bone canals and marrow spaces and induced resorption of the surrounding bone. In four cases in Group A, tissue from the osteolysis contained only fragmented bone cement, demonstrating that PMMA particles alone may be responsible for triggering focal bone resorption. Osteolysis seems to begin at the site where disintegration of bone cement begins. In cases in which polyethylene particles were found in the tissue in addition to fragmented bone cement, wear from the ultrahigh molecular weight polyethylene socket has been increased by entrapment of PMMA particles between the joint surfaces. Thus, fragmentation of bone cement and abrasion of polyethylene enhance each other. Bone cement particles promote polyethylene wear, which in turn promotes granuloma formation, bone resorption, and subsequent bone cement disintegration.

Osteolysis in alloarthroplasty of the hip. The role of ultra-high molecular weight polyethylene wear particles.

Massive localized osteolysis around artificial joints has been seen more frequently in the past few years. It is still not generally accepted that ultra-high molecular weight polyethylene (UHMWPE) wear particles can induce massive bone resorption, even distant from the joint. This article describes a series of eight soft-top prostheses with large UHMWPE ball heads that contributed to the erosion of surrounding bone. Roentgenographically, all of the cases showed a marked loss of proximal cortical bone, more or less combined with osteolysis, which was distal to the femoral shaft and deep into the acetabulum. In two cases, remodeling and resorption transformed the bone into a tumorlike appearance. Tissue samples from areas of osteolysis as well as from the joint capsule were taken at revision surgery, processed for histology, examined microscopically, and evaluated semiquantitatively. The retrieved devices were also carefully inspected. Large amounts of UHMWPE wear debris were found not only in the joint capsule but also in layers of granulomatous tissue from the acetabulum and femur, whereas metal particles and fragmented polymethylmethacrylate were either completely absent or occurred only in very small amounts. The results of this study demonstrate that UHMWPE wear products alone can cause massive osteolysis by triggering foreign-body granuloma formation at the bone-cement interface; the bone cement may remain fixed in areas beyond the osteolytic transformation.

[In vitro toxicity and mutagenicity of CoCrMo and TiAl wear particles]. / In-vitro-Toxizität und Mutagenität von CoCrMound TiAl-Abriebpartikeln.

Contact of wear particles with body fluids can result in widespread dissemination of extractable constituents from joint implants. The aim of this in vitro study is to clarify whether there is a mutagenic and/or carcinogenic risk from Co(28)Cr(6)Mo and Ti(6)Al(4)V wear particles. Particles of a representative size were produced by fretting; toxicity and mutagenicity were investigated using the Ames Salmonella/microsome test and the V79-HGPRT Test (Chinese hamster fibroblasts). To obtain the greatest possible elution of all constituents, the metallic wear particles were extracted with DMSO and water and the resulting eluates mixed together. After repeated test series under standardized conditions, neither the bacterial nor the mammalian cell assays produced evidence of toxic or mutagenic effects in the concentration range under study. It is therefore not to be expected that CoCrMo or TiAl alloys initiate carcinogenesis in the human organism.

Wear behavior and histopathology of classic cemented metal on metal hip endoprostheses.

The authors reviewed their collection of retrieved all metal hip joints (9 McKee-Farrar, 7 Müller, and 3 Huggler type prostheses) and tissues from the joint capsules and implant beds. The amount of wear was measured, and the total volume was calculated. The tissues were analyzed by atomic absorption spectral analysis or inductively coupled plasma mass spectrometry and examined by light and scanning electron microscopy. The size of particles was measured with a texture analysis system. The articulating surfaces showed many delicate scratches which represent normal wear. The calculated annual wear averaged approximately 5 mm3 per year, which is low compared with polyethylene. The cellular reaction to metal wear particles was regarded as mild. The cellular reaction to scattered and worn bone cement was always more pronounced than to metallic debris. Scanning electron microscopy confirmed the irregular shapes and mostly submicron size of the metal particles. The analytically detected metal content of the periarticular tissue was relatively low and in accordance with the wear measurements from the articulating surfaces. The excess of chromium in the tissues is discussed in the light of the elimination of cobalt as well as the relation between elements representing either corrosion products or elements still bound in wear particles.

Crevice corrosion of cemented titanium alloy stems in total hip replacements.

Twenty-eight cemented Müller straight femoral stems of titanium forged alloys were mainly revised for causing pain in the patient. The pain pattern differed from aseptic loosening and pain recurred only 14.5 months on average after implantation. The character of pain was dull, permanent, and increased at rest. Some patients reported pain relief while walking. Revisions were performed on average 25.5 months after primary implantation. Data from medical records, radiographs, histology of tissues taken at revision surgery, intraoperative pH measurements, examination of retrieved stems and bone cement fragments were gathered. In the radiographs debonding was visible only in 3 cases; a spindle shaped thickening of the femora occurred 9 months on average after recurrence of pain. After a further 11 months (average), scalloping osteolyses appeared. Abraded particles like metallic titanium alloy, titanium corrosion products, polymethylmethacrylate, xray contrast medium, and polyethylene were detected. Metallic particles dominated in the joint capsule whereas more corrosion products impregnated the cement to bone interface. The distal surfaces of the stems were corroded at a higher rate, whereas the proximal regions more often were subject to abrasion. Measurements of the pH of the corroded stems revealed values of high acidity. Recurrence of pain and subperiosteal apposition of bone are due to diffusion of acid; subsequent scalloping osteolyses develop due to particle induced foreign body granulomas. The mechanism of crevice corrosion of cemented titanium based alloys does not seem applicable to cobalt and iron based implant alloys. Titanium alloys can no longer be recommended for cementation, but are as safe as ever for anchorage without cement.