Cementless total knee replacement fixation: a contemporary durable solution--affirms.

A retrospective review was performed of patients undergoing primary cementless total knee replacement (TKR) using porous tantalum performed by a group of surgical trainees. Clinical and radiological follow-up involved 79 females and 26 males encompassing 115 knees. The mean age was 66.9 years (36 to 85). Mean follow-up was 7 years (2 to 11). Tibial and patellar components were porous tantalum monoblock implants, and femoral components were posterior stabilised (PS) in design with cobalt-chromium fibre mesh. Radiological assessments were made for implant positioning, alignment, radiolucencies, lysis, and loosening. There was 95.7% survival of implants. There was no radiological evidence of loosening and no osteolysis found. No revisions were performed for aseptic loosening. Average tibial component alignment was 1.4° of varus (4°of valgus to 9° varus), and 6.2° (3° anterior to 15° posterior) of posterior slope. Mean femoral component alignment was 6.6° (1° to 11°) of valgus. Mean tibiofemoral alignment was 5.6° of valgus (7° varus to 16° valgus). Patellar tilt was a mean of 2.4° lateral (5° medial to 28° lateral). Patient satisfaction with improvement in pain was 91%. Cementless TKR incorporating porous tantalum yielded good clinical and radiological outcomes at a mean of follow-up of seven-years.

Major joint replacement. A model for antithrombotic drug development: from proof-of-concept to clinical use.

AIM: Development of antithrombotic compounds has traditionally been performed in patients undergoing total hip and knee replacement surgery. A high number of asymptomatic deep-vein thromboses are radiologically detectable, and bleeding and other adverse events (AE) are easy to observe. However, standardization of study procedures and endpoints in early proof-of-concept studies and late pure clinical endpoint studies has been lacking. This has made comparison between studies difficult, economic analyses speculative and potential benefits of applying the drug regimen in non-selected patients uncertain. In this paper, the International Surgical Thrombosis Forum proposes a strategy for the clinical investigation of new pharmacological agents for the prophylaxis of postoperative thrombotic events. METHODS: First, dose titration safety studies of short duration, in highly selected patients using objective venographic endpoints are recommended. Bleeding should be divided into the quantified volume of surgical bleeding and other adjudicated clinical bleeding events. The number of AE should be described for each dose step and classified according to International Coding of Diagnoses (ICD). Second, a dose confirmatory study of moderate exposure period and sufficient follow-up time is recommended. The exclusion criteria should be restricted to contraindications of the compared drugs and technical procedure. RESULTS: The efficacy, bleeding and AE should be similar to those used in dose-titration studies. In addition, the failure rate of the drug to exert its effect and the net clinical benefit should be calculated. CONCLUSION: Finally, trials with simple clinical endpoints and long follow-up should be conducted to evaluate the potential benefits of the drug-regimen in non-selected populations.

BAY 59-7939: an oral, direct factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement. A phase II dose-ranging study.

BACKGROUND: BAY 59-7939, a novel, oral, direct factor Xa inhibitor, is in clinical development for the prevention of venous thromboembolism (VTE), a frequent complication following orthopaedic surgery. METHODS: In a multicenter, parallel-group, double-blind, double-dummy study, 621 patients undergoing elective total knee replacement were randomly assigned to oral BAY 59-7939 (2.5, 5, 10, 20, and 30 mg b.i.d., initiated 6-8 h postsurgery), or subcutaneous enoxaparin (30 mg b.i.d., initiated 12-24 h postsurgery). Treatment was continued until mandatory bilateral venography 5-9 days after surgery. The primary efficacy endpoint was a composite of any deep vein thrombosis (proximal and/or distal), confirmed non-fatal pulmonary embolism and all-cause mortality during treatment. The primary safety endpoint was major, postoperative bleeding during treatment. RESULTS: Of the 613 patients treated, 366 (59.7%) were evaluable for the primary efficacy analysis. The primary efficacy endpoint occurred in 31.7%, 40.4%, 23.3%, 35.1%, and 25.4% of patients receiving 2.5, 5, 10, 20 and 30 mg b.i.d. doses of BAY 59-7939, respectively (test for trend, P = 0.29), compared with 44.3% in the enoxaparin group. The frequency of major, postoperative bleeding increased with increasing doses of BAY 59-7939 (test for trend, P = 0.0007), with no significant difference between any dose group compared with enoxaparin. Bleeding endpoints were lower for the 2.5-10 mg b.i.d. doses compared with higher doses of BAY 59-7939. CONCLUSIONS: Oral administration of 2.5-10 mg b.i.d. of BAY 59-7939, early in the postoperative period, showed potential efficacy and an acceptable safety profile, similar to enoxaparin, for the prevention of VTE in patients undergoing elective total knee replacement.

A quantitative in vitro assessment of fit and screw fixation on the stability of a cementless hemispherical acetabular component.

This investigation quantifies in vitro the effect of component fit, as well as the effect of adjuvant screw fixation, on the initial stability of cementless hemispherical titanium acetabular total hip arthroplasty components and assesses apposition of the acetabular components to bone. Six, fresh human hemipelvi (3 matched pairs) were harvested at autopsy. Titanium alloy acetabular components with a porous surface of commercially pure titanium fiber mesh (Harris Galante Porous acetabular components, Zimmer, Warsaw, IN) were used for implantation. Initially, each acetabulum was underreamed to achieve a 2 mm press-fit with the acetabular component. Pressure-sensitive film had been placed along the dome and medial wall at the bone-implant interface to assess the completeness of seating. After the implant was impacted into the acetabular cavity, relative motion between the implant and bone was measured during simulated single leg stance. Adjuvant fixation of the implant was then obtained with the insertion of four 6.5 mm cancellous screws. High-contrast roentgenograms of the specimens in multiple views were obtained after initial cup insertion and again after screw insertion. The stability of each implant under load was measured with four, three, two, one, and no screws in place. Further reaming of the bone was done to create a 1 mm press-fit. The sequence was then repeated. Further reaming was done to create an exact-fit and the sequence was repeated again. Under these conditions, 1 mm press-fit with or without screws provided the optimum combination of fit stability.(ABSTRACT TRUNCATED AT 250 WORDS)

High failure rate of bulk femoral head allografts in total hip acetabular reconstructions at 10 years.

The authors evaluated the radiographic appearance and functional performance of 30 cemented total hip arthroplasty acetabular reconstructions in 28 patients in whom bulk, weight-bearing, femoral head allografts were used to augment severe acetabular bone deficiency with a mean follow-up period of 10 years (range, 8-13.3 years). The average age of the patients was 51 years. The current study group represents the 10-year subset of a larger series of 38 hip reconstructions previously reported. The graft was bolted within the acetabulum in 12 hips and to the lateral wing of the ilium in the other 18 hips. On average, these grafts supported approximately 60% of the acetabular component. All grafts united. Failure of fixation of the acetabular component occurred in 47% of the acetabular reconstructions (14 hips in 14 patients). Four were diagnosed as loose on the basis of radiographic criteria alone and the other 10 hips had a loose acetabular component at reoperation. Loosening occurred in 58% (7 of 12) of the sockets with intraacetabular graft and in 40% (7 of 18) of those bolted to the lateral ilium. The failure rate of 47% in these reconstructions at 10 years is in sharp contrast to high success rates at less than 5 years and argues against the use of bulk weight-bearing allografts for most situations unless the only alternative is resection arthroplasty.

Autopsy studies of the bone-cement interface in well-fixed cemented total hip arthroplasties.

Although knowledge of the clinical status of the implant is important, only instrumented mechanical testing of retrieved specimens provides quantitative assessment of implant fixation. This measurement allows placement of the implant along a continuum of loosening and is the foundation for the interpretation of subsequent findings. Analysis of implants that have been proven to be well fixed by instrumented testing reveals significant differences in the initial events in the loosening of femoral and acetabular components. Although radiolucencies were observed around all of these well-fixed femoral and acetabular components, the histology (and therefore the etiology) of the radiolucency is different and variable on the two sides of the articulation. The majority of femoral radiolucencies appear to be due to age and stress-related remodeling while particulate-induced bone resorption plays an important role in acetabular radiolucencies. A finding common to both sides of the articulation in these stable components, however, was intimate contact of bone with cement without any interposed soft tissue even after 17.5 years of service. Primary incompatibility and/or failure of the cement was not identified as a factor in initiating either femoral or acetabular component loosening. These studies document the long-term compatibility of bone with cement in bulk form. Improvements in cemented femoral component fixation should focus on stem design and cementing technique. Long-term acetabular component fixation can be improved by reduction or elimination of polyethylene wear and optimization of the bone-implant interface.

The histology of the radiolucent line.

The radiographic and histological features of radiolucent areas at the cement-bone interface were correlated in 15 specimens retrieved at post-mortem from patients who had undergone cemented total hip arthroplasty, two weeks to 15 years prior to death. All but one of the components were securely fixed, as demonstrated by direct measurements of micromotion. Extensive radiolucencies were present in all but one case. In 11 of the 14 specimens with radiolucencies, histological examination showed that the radiolucent areas represented regions of osteoporosis and bone remodelling. The remodelling changes were characterised by osteoporosis, cancellisation and thinning of the endosteal cortex, and osteopenia of the trabecular bone. In two specimens the appearance of radiolucency was found to be due to fibrous tissue at the cement-bone interface and in one specimen there was a mixed picture of osteolysis and fibrosis. The study demonstrates that radiolucent lines can occur with well-fixed components and that they may commonly represent osteoporosis rather than the presence of a fibrous membrane at the cement-bone interface.

The mechanism of loosening of cemented acetabular components in total hip arthroplasty. Analysis of specimens retrieved at autopsy.

Late aseptic loosening of cemented acetabular components is governed by the progressive, three-dimensional resorption of the bone immediately adjacent to the cement mantle. This process begins circumferentially at the intraarticular margin and progresses toward the dome of the implant. Evidence of bone resorption at the cement-bone interface was present even in the most well-fixed implants before the appearance of lucent lines on standard roentgenographic views. The mechanical stability of the implant was determined by the three-dimensional extent of bone resorption and membrane formation at the cement-bone interface. The leading edge of the membrane is a transition zone from regions of membrane interposition between the cement and the bone to regions of intimate cement-bone contact. Histologic analysis revealed that progressive bone resorption is fueled by small particles of high density polyethylene (HDP) migrating along the cement-bone interface and bone resorption occurs as a result of the macrophage inflammatory response to the particulate HDP. Evidence in support of a mechanical basis for failure of fixation was lacking. The mechanism of late aseptic loosening of a cemented acetabular component is therefore biologic in nature, not mechanical. This is exactly opposite to the mechanism of loosening on the femoral side of a cemented total hip replacement, which is mechanical in nature.

Shielding of the patient's gonads during intramedullary interlocking femoral nailing.

Levels of exposure to radiation were recorded at sixty sites in fifteen patients during intramedullary interlocking femoral nailing. Radiation film dosimeters were placed at four gonadal sites on each subject. A standard male-gonad cup or a pelvic drape of 0.5-millimeter-thick lead-equivalent was put in place to shield the gonads. A second set of four dosimeters was placed external to the shield to approximate unprotected exposure. The total duration of the fluoroscopy averaged five minutes (range, thirty seconds to fourteen minutes). The total exposure to radiation external to the shield was 35 +/- 34 millirems at the male gonadal sites and 17 +/- 11 millirems at the female gonadal sites. With use of the gonadal shield, exposure to radiation was not measurable in thirteen of the fifteen patients. The differences between the exposures of the shielded and unshielded sites to radiation were statistically significant (p less than 0.001). The highest level of gonadal exposure was found with the treatment of proximal femoral fractures and with the use of statically locked nails. Regardless of the conditions, and for all types of fractures and locations, our results demonstrated that gonadal shielding is justified.

Postocclusive transcutaneous oximetry in followup assessment of tibial nonunion and healed tibia fractures.

UNLABELLED: Transcutaneous oximetry measurements were performed on 25 limbs in 25 patients with clinical and radiographic nonunion, and compared with data obtained from patients with healed tibia fractures and a control group of nonfractured extremities. A technique of "stress testing" vascular inflow patterns by temporary occlusion of arterial inflow was utilized to accentuate differences in perfusion not apparent at rest between normal limbs and those with inflow impairment. Changes in postocclusive hyperemic response were monitored by changes in transcutaneous oxygen detected by sensors placed over the dorsum of the foot, at the fracture site, over the anterior compartment, and at the chest. No statistically significant differences were found between the control group and the group of united tibia fractures. Analysis of results using the unpaired Student's t-test demonstrated statistically significant differences between the control and nonunion groups at each limb site tested (p less than 0.05). The prolonged oxygen recovery time values found in more than half the limbs with nonunion are consistent with the presence of impaired oxygenation following physiologic stress. The impairment of oxygenation appears to be on a perfusion basis and reflects the limited capacity of many limbs with tibial nonunion to respond to experimental ischemia with immediate compensatory hyperemia. CLINICAL RELEVANCE: This technique is a feasible method for serially assessing the regional oxygenation of a limb, and substantiates ischemia as a possible factor in the genesis of tibial nonunion.