The effects of altered strain environments on bone tissue kinetics.

This study defines the alteration in bone tissue kinetics responsible for the "adaptive remodeling" response to altered strain environments. Adult beagle dogs were separated into three experimental groups: ulnar osteotomy, ulnar osteotomy with fracture fixation plate spanning the gap and sham surgery. Four sets of double fluorochrome labels were administered. Prior to sacrifice at 1, 3, and 6 months, strains were measured through rosette strain gages on the cranial and caudal surfaces of the intact radius. Histomorphometric analysis indicated that the increased bone mass in response to elevated strain results from increased activation frequency of modeling with more sites undergoing formation processes than resorption processes on periosteal and endocortical surfaces. Increased remodeling activation did not lead to increased bone mass. There was no evidence that elevated strain changes the individual vigor of osteoclasts or osteoblasts, or that the sigma period was altered by elevated strain.

Skeletal change in response to altered strain environments: is woven bone a response to elevated strain?

Studies demonstrate that geometric changes in bone architecture in response to altered mechanical strain occur through the formation of woven bone. The goal of this study was to test the hypothesis that these changes are partly the result of surgical manipulation rather than a true adaptive response to altered strain. Beagle dogs were subjected to either an ulnar osteotomy, an osteotomy with plate fixation, or sham operation. Strains on the radius were measured just prior to sacrifice 1, 3 or 6 months after surgery. Our results support the idea that woven bone can be a normal response to an abnormal strain environment if the mechanical challenge is intense enough; that elevated mechanical strains can cause the endocortical bone envelope to revert to a state of net formation; and that "adaptive remodeling" in adults in response to a change in mechanical strain may be a special case of modeling in which resorption is not required prior to formation at a particular skeletal site.

Patients' recall of preoperative instruction for informed consent for an operation.

Thirty-eight consecutive patients who were admitted to the hospital for total joint replacement were studied to determine their understanding of the elements of informed consent at the time when they signed the consent document before the operation and their recall of those elements six months after the operation. All patients received instruction from the same patient-educator before the operation. Each patient was asked to respond verbally to a questionnaire about the preoperative instruction. If a question was not answered correctly, tutoring was given until the patient gave the correct response. The consent document was not presented for signature until the patient could answer all questions correctly. In an interview six months after the operation, thirty-six of the thirty-eight patients were asked the same questions that they had answered before the operation. The recall of risks and benefits six months after the operation was compared with the understanding of risks and benefits that had been demonstrated before the operation by both the verbal questioning and the signed consent document. At six months, the number of patients who recalled the risks ranged from nine (25 per cent) who remembered the risk of infection to only one who remembered the risk of damage to a nerve or artery. More patients recalled the potential benefits: eight (22 per cent) for relief of pain and improved function and five (16 per cent) for improved motion.

Use of enoxaparin, a low-molecular-weight heparin, and unfractionated heparin for the prevention of deep venous thrombosis after elective hip replacement. A clinical trial comparing efficacy and safety. Enoxaparin Clinical Trial Group.

A randomized, parallel-group, open-label clinical trial (the physicians, patients, and staff were not blinded with regard to the regimen that had been used) was conducted, between December 1988 and September 1990, to compare the safety and efficacy of enoxaparin, a low-molecular-weight heparin, with the safety and efficacy of unfractionated heparin for the prevention of deep venous thrombosis after elective hip replacement. Six hundred and ten patients were randomized, and 607 patients received one of the study medications. The evaluations of efficacy included contrast-media venography, non-invasive vascular examination, and clinical examination. Data on efficacy were available for 604 patients, who had been assigned to one of three treatment groups: thirty milligrams of enoxaparin every twelve hours (194 patients), forty milligrams of enoxaparin once daily (203 patients), or 5000 units of unfractionated heparin every eight hours (207 patients). All drugs were administered subcutaneously. Dosages were not adjusted on the basis of the results of coagulation tests or the body weight of the patient. Treatment was initiated within twenty-four hours after the operation and continued for a maximum of seven days. The primary safety outcome was the occurrence of bleeding episodes. An intent-to-treat patient analysis revealed that deep venous thrombosis occurred in nine (5 per cent) of the 194 patients who received thirty milligrams of enoxaparin every twelve hours, thirty (15 per cent) of the 203 patients who received forty milligrams of enoxaparin once daily, and twenty-four (12 per cent) of the 207 patients who received unfractionated heparin. The rate of deep venous thrombosis was significantly lower in the group that received thirty milligrams of enoxaparin every twelve hours than in the group that received unfractionated heparin (p = 0.03) and in the group that received forty milligrams of enoxaparin once daily (p = 0.0002). No clinically symptomatic pulmonary embolism was observed during the treatment or follow-up phase of this study in the group that received thirty milligrams of enoxaparin every twelve hours. Analysis of evaluable patients revealed a marked reduction in the rate of deep venous thrombosis in the group that received thirty milligrams of enoxaparin every twelve hours (eight [6 per cent] of 136 patients) compared with the group that received heparin (twenty-one [15 per cent] of 145 patients) (p = 0.10); however, this difference was not significant because of the small number of patients included in this analysis.(ABSTRACT TRUNCATED AT 400 WORDS)

Stem surface roughness alters creep induced subsidence and 'taper-lock' in a cemented femoral hip prosthesis.

The clinical success of polished tapered stems has been widely reported in numerous long term studies. The mechanical environment that exists for polished tapered stems, however, is not fully understood. In this investigation, a collarless, tapered femoral total hip stem with an unsupported distal tip was evaluated using a 'physiological' three-dimensional (3D) finite element analysis. It was hypothesized that stem-cement interface friction, which alters the magnitude and orientation of the cement mantle stress, would subsequently influence stem 'taper-lock' and viscoelastic relaxation of bone cement stresses. The hypothesis that creep-induced subsidence would result in increases to stem-cement normal (radial) interface stresses was also examined. Utilizing a viscoelastic material model for the bone cement in the analysis, three different stem-cement interface conditions were considered: debonded stem with zero friction coefficient (mu=0) (frictionless), debonded stem with stem-cement interface friction (mu=0.22) ('smooth' or polished) and a completely bonded stem ('rough'). Stem roughness had a profound influence on cement mantle stress, stem subsidence and cement mantle stress relaxation over the 24-h test period. The frictionless and smooth tapered stems generated compressive normal stress at the stem-cement interface creating a mechanical environment indicative of 'taper-lock'. The normal stress increased with decreasing stem-cement interface friction but decreased proximally with time and stem subsidence. Stem subsidence also increased with decreasing stem-cement interface friction. We conclude that polished stems have a greater potential to develop 'taper-lock' fixation than do rough stems. However, subsidence is not an important determinant of the maintenance of 'taper-lock'. Rather subsidence is a function of stem-cement interface friction and bone cement creep.

Radionuclide bone imaging findings in loose cemented joint prostheses appear to be normal postoperative findings in cementless joint prostheses. Preliminary case report.

Two cases exemplify that three point uptake on radionuclide bone scans within the first postsurgical year of press-fit cementless joint prostheses appear to be a normal physiomechanical finding.

Cementless fixation of the tibial component for the ICLH knee.

The use of polymethylmethacrylate bone cement in joint replacement surgery is not without drawbacks. Certain hazards have been appreciated and the bone cement interface may not be as stable in the long run as was once felt. This paper reports the results in 52 knees which were replaced using the uncemented ICLH (Imperial College/London Hospital) tibial component; the average follow up was two years (range six months to four years). The results were compiled with regard to pain as well as clinical examination and X-ray evaluation. The results were comparable to those achieved in knees replaced using bone cement. Roentgenographic evaluation revealed no evidence of loosening nor sinkage of any of these prostheses. Considerations in the development of a knee prosthesis to be utilized without bone cement and the operative technique employed to implant such a prosthesis are presented. The merits of such a system are discussed.

Bone creep and short and long term subsidence after cemented stem total hip arthroplasty (THA).

Stem-cement and cement-bone interfacial failures as well as cement fractures have been noted in cemented total hip arthroplasty (THA) as the cause of aseptic loosening. Attempts to reduce the risk of femoral component loosening include improving the stem-cement interface by various coatings, using a textured or porous coated stem surfaces or by using a tapered stem having a highly-polished surface. The latter approach, often referred to as "force-closed" femoral stem design, would theoretically result in stem stabilization subsequent to debonding and 'taper-lock'. Previous work using three-dimensional finite element analysis has shown a state of stress at the stem-cement interface indicative of 'taper-lock' for the debonded stem and indicated that stem-cement interface friction and bone cement creep played a significant role in the magnitudes of stresses and subsidence of the stem. However, the previous analysis did not include the viscoelastic properties of bone, which has been hypothesized to permit additional expansion of the bone canal and allow additional stem subsidence (Lu and McKellop, 1997). The goal of this study was to investigate the effect of bone viscoelastic behavior on stem subsidence using a 3D finite element analysis. It was hypothesized that the viscoelastic behavior of bone in the hoop direction would allow expansion of the bone reducing the constraint on bone over time and permit additional stem subsidence, which may account for the discrepancies between predicted and clinical subsidence measurements. Analyses were conducted using physiological loads, 'average peak loads' and 'high peak loads' for 'normal patient' and 'active patient' (Bergmann et al., 2010) from which short and long term subsidence was predicted. Results indicated that bone creep does contribute to higher stem subsidence initially and after 10 years of simulated loading. However, it was concluded that the "constraint" upon the cement mantle is not mitigated enough to result in stem subsidence equivalent to that observed clinically.

Cortical bone viscoelasticity and fixation strength of press-fit femoral stems: finite element model.

Many cementless implant designs rely upon a diaphyseal press-fit in conjunction with a porous coated implant surface to achieve primary or short term fixation, thereby constraining interface micromotion to such a level that bone ingrowth and consequent secondary or long-term fixation, i.e., osseointegration, can occur. Bone viscoelasticity, however, has been found to affect stem primary stability by reducing push-out load. In this investigation, an axisymmetric finite element model of a cylindrical stem and diaphyseal cortical bone section was created in order to parametrically evaluate the effect of bone viscoelasticity on stem push-out while controlling coefficient of friction (mu = 0.15, 0.40, and 1.00) and stem-bone diametral interference (delta = 0.01, 0.05, 0.10, and 0.50 mm). Based on results from a previous study, it was hypothesized that stem-bone interference (i.e., press-fit) would elicit a bone viscoelastic response which would reduce the initial fixation of the stem as measured by push-out load. Results indicate that for all examined combinations of mu and delta, bone viscoelastic behavior reduced the push-out load by a range of 2.6-82.6% due to stress relaxation of the bone. It was found that the push-out load increased with mu for each value of delta, but minimal increases in the push-out load (2.9-4.9%) were observed as delta was increased beyond 0.10 mm. Within the range of variables reported for this study, it was concluded that bone viscoelastic behavior, namely stress relaxation, has an asymptotic affect on stem contact pressure, which reduces stem push-out load. It was also found that higher levels of coefficient of friction are beneficial to primary fixation, and that an interference "threshold" exists beyond which no additional gains in push-out load are achieved.

Cortical bone viscoelasticity and fixation strength of press-fit femoral stems: an in-vitro model.

Cementless total hip femoral components rely on press-fit for initial stability and bone healing and remodeling for secondary fixation. However, the determinants of satisfactory press-fit are not well understood. In previous studies, human cortical bone loaded circumferentially to simulate press-fit exhibited viscoelastic, or time dependent, behavior. The effect of bone viscoelastic behavior on the initial stability of press-fit stems is not known. Therefore, in the current study, push-out loads of cylindrical stems press-fit into reamed cadaver diaphyseal femoral specimens were measured immediately after assembly and 24 h with stem-bone diametral interference and stem surface treatment as independent variables. It was hypothesized that stem-bone interference would result in a viscoelastic response of bone that would decrease push-out load thereby impairing initial press-fit stability. Results showed that push-out load significantly decreased over a 24 h period due to bone viscoelasticity. It was also found that high and low push-out loads occurred at relatively small amounts of stem-bone interference, but a relationship between stem-bone interference and push-out load could not be determined due to variability among specimens. On the basis of this model, it was concluded that press-fit fixation can occur at relatively low levels of diametral interference and that stem-bone interference elicits viscoelastic response that reduces stem stability over time. From a clinical perspective, these results suggest that there could be large variations in initial press-fit fixation among patients.

In vivo measurements of relative motion between an uncemented femoral total hip component and the femur by roentgen stereophotogrammetric analysis.

Roentgen stereophotogrammetric analysis (RSA) was used to study rotation and subsidence of an uncemented polyethylene-coated femoral component for total hip arthroplasty in ten patients younger than 55 years of age. Three years postoperatively, the total subsidence averaged 2.44 mm and the internal rotation was 7.4 degrees. The rate of subsidence decreased between the observation periods, whereas the rate of rotation, after an initial significant decrease, became almost constant. One patient, who was a clinical failure and required revision arthroplasty, had a significantly higher rate of migration after six months. The pattern of subsidence in the absence of pain might be the normal reaction of bone to an uncemented prosthesis, but the continuing rotation suggests the potential for failure of the arthroplasty. The type of analysis made possible in RSA may allow early prediction of the success of arthroplasties and significantly speed the design cycle for arthroplasty components.

Alignment in total knee arthroplasty. Correlated biomechanical and clinical observations.

The initial experience with the Freeman-Swanson (ICLH) total knee arthroplasty (1971-1975) led to changes of tibial component size, alignment, instruments, and surgical technique in 1975. Certain patients in this initial series, however, have shown excellent long-term (5 1/2-9 years) results. In patients with overall alignment between 1 degrees and 13 degrees valgus, the success rate was 89%. In patients with knees aligned between neutral and 8 degrees varus, the success rate was only 14%. This startling difference in long-term results was investigated by using eccentric loading tests to simulate varus and valgus malalignment. Knee arthroplasties failed in eccentric loading at very low loads. Failure by lift-off of the unloaded side occurred at 9%-18% and failure of bone due to compression on the loaded side occurred at 34%-51% of the load at failure under ideal uniform loading conditions. Thus, both the long-term clinical study and the laboratory analysis demonstrate the importance of proper overall alignment in total knee arthroplasty.

Characterization of link protein(s) from human intervertebral-disc tissues.

Proteoglycan aggregates (A1) were prepared from the anulus fibrosus, nucleus pulposus and cartilage-endplate tissues of postnatal (0-6-month-old)-and young-adult (20-30-year-old)-human intervertebral discs. The A1 fractions from young-adult disc contained a greater proportion of non-aggregating proteoglycans than did postnatal tissues. After dissociative CsCl-density-gradient fractionation of the A1, more than 90% of the uronic acid was found in the postnatal A1D1, whereas only 60-80% of the hexuronate was present in the A1D1 isolated from young-adult disc tissues. These results indicated that more lower-buoyant-density proteoglycans occur in the young-adult disc. Link-protein-rich fractions (A1D3) were subjected to SDS/polyacrylamide-gel electrophoresis and immunolocation analyses using monoclonal antibodies specific for epitopes on link protein or proteoglycan. Under non-reducing conditions, the major link protein present in postnatal disc tissues was link protein 1. By contrast, all three link proteins (1, 2 and 3) were detected in young-adult tissues, with the smaller link protein 3 predominating. Analyses of the A1D3 fractions under reducing conditions also indicated the presence of link-protein-degradation peptides (Mr approx. 26,000) from young-adult disc tissues, but not from postnatal tissues. Sequential Sepharose CL-6B and Sephacryl S-300 chromatography in 4 M-guanidinium chloride was employed to separate the link proteins of the A1D3 fraction from protein-rich proteoglycan. Immunolocation analyses indicated that postnatal samples contained no detectable contaminating proteoglycan fragments. However, young-adult link-protein preparations could not be separated from hyaluronic acid-binding region and other proteoglycan fragments by means of these chromatographic procedures. The studies indicate that, compared with hyaline articular cartilage, degraded link protein and proteoglycan accumulate at an early age in young-adult disc tissues. These partially degraded proteoglycan aggregate components may significantly alter the biomechanical properties of disc tissues.

Audiometric thresholds in osteomyelitis patients treated with gentamicin-impregnated methylmethacrylate beads (Septopal).

Use of gentamicin-impregnated methylmethacrylate beads is a relatively new and effective method of treating osteomyelitis. Although previous studies have concluded that such therapy is associated with low systemic toxicity, no data are available relating the use of this treatment to ototoxicity and hearing loss. Audiometric thresholds from 28 cases of osteomyelitis treated by surgical debridement and long-term systemic antibiotics alone (14 subjects) or gentamicin-impregnated methylmethacrylate beads either alone or combined with systemic antibiotics (14 subjects) were analyzed. Results showed one permanent threshold shift in the gentamicin-impregnated methylmethacrylate beads group (8%) versus four permanent threshold shifts in the systemic antibiotics alone group (29%). Osteomyelitis patients treated with gentamicin-impregnated methylmethacrylate beads are at no more risk and are probably at less risk of experiencing ototoxicity than patients treated with conventional long-term systemic antibiotics.