Ten-year results of the first 100 Genesis II total knee replacement procedures.

The first 100 consecutive Genesis II (Smith & Nephew; Memphis, Tenn) total knee replacements (TKR) procedures performed in 97 patients by the senior investigators (RBB, RSL) had a Kaplan-Meier survivorship of 96% +/- 2% at 12 years with any reoperation as the endpoint. Significant improvements in health-related quality-of-life outcome measures were noted. There were no revisions for implant-related factors (ie, polyethylene wear, osteolysis, or aseptic loosening). No implant demonstrated radiographic loosening. The features of this device are discussed as well as its long-term performance.

Fractures of distally-fixed femoral stems after revision arthroplasty.

We identified five (2.3%) fractures of the stem in a series of 219 revision procedures using a cementless, cylindrical, extensively porous-coated, distally-fixed femoral stem. Factors relating to the patients, the implant and the operations were compared with those with intact stems. Finite-element analysis was performed on two of the fractured implants. Factors associated with fracture of the stem were poor proximal bone support (type III-type IV; p = 0.001), a body mass index > 30; (p = 0.014), a smaller diameter of stem (< 13.5 mm; p = 0.007) and the use of an extended trochanteric osteotomy (ETO 4/5: p = 0.028). Finite-element analysis showed that the highest stresses on the stem occurred adjacent to the site of the fracture. The use of a strut graft wired over an extended trochanteric osteotomy in patients lacking proximal femoral cortical support decreased the stresses on the stem by 48%.We recommend the use of a strut allograft in conjunction with an extended trochanteric osteotomy in patients with poor proximal femoral bone stock.

An evaluation of three loading configurations for the in vitro testing of femoral strains in total hip arthroplasty.

Despite recent advances in total hip arthroplasty, proximal femoral resorption and osteopenia remain problems. To analyze the proximal strain effects of three different loading conditions, strains produced in intact and postarthroplasty femora have been compared. Ten adult cadaveric femora of similar size, shape, and rigidity were tested. Ten strain-gauge rosettes were positioned on each femur. To simulate the "single leg support" phase of gait, fixtures were developed to load the femora under three different configuration: the VS (vertical shaft) configuration, with a vertically orientated femur having rotational freedom proximally and distally; the ITB (iliotibial band) configuration of a femur with rotational freedom positioned 11 degrees from the vertical, with a strain-gauge adjustable metallic simulation of the lateral muscles of the thigh; and the ABD (abductor) configuration of a femur with rotational freedom positioned 11 degrees from the vertical, with a strain-gauge adjustable metallic simulation of the abductor muscles. Each femur was loaded less than or equal to 600 N through the medial point, located at one sixth of the transcondylar distance. Strain patterns and magnitudes produced by the three loading configurations were quite different in both the intact and postarthroplasty femora. Both the ITB and the ABD configurations resulted in greater proximal medial compression and lateral tension than did the VS configuration. The magnitudes of the proximal strains were significantly greater in the ABD configuration (p less than 0.05). Postarthroplasty femora showed similar proximal results. It is proposed that meaningful strain data for the physiologically loaded femur can be obtained only with simulations that include the forces produced by the iliotibial band. To overcome the indeterminate nature and biological variation in these forces, the studies have to consider a range of forces.

The cemented kinematic-II and the non-cemented porous-coated anatomic prostheses for total knee replacement. A prospective evaluation.

One hundred and sixty consecutive total knee arthroplasties were performed in 143 patients: 110 procedures, with a cemented kinematic-II prosthesis and fifty procedures, with a non-cemented porous-coated anatomic prosthesis. Each patient was evaluated before the operation and six weeks and three, six, twelve, and twenty-four months postoperatively. At a minimum twenty-four-month follow-up, the average Hospital for Special Surgery knee-rating score for the patients who had a cemented kinematic-II prosthesis was 9 points higher than the average score for the patients who had a non-cemented anatomic implant (88 points and 79 points). At the same follow-up period, the maximum flexion of the knees that had a cemented kinematic-II prosthesis was greater than that of the knees that had a non-cemented anatomic prosthesis (106 degrees and 97 degrees). In addition, the rate of reoperation for the patients who had a cemented kinematic-II replacement was 4 per cent, compared with 12 per cent for the patients who had a non-cemented anatomic prosthesis. On the basis of this prospective, non-randomized clinical review of unselected patients, we concluded that the results with the cemented kinematic-II prosthesis were superior to those with the non-cemented anatomic prosthesis at a minimum twenty-four month follow-up; however, these superior results may be related to the use of cement or to differences in the designs of the prostheses, the ages of the patients, or the postoperative management of the two groups of patients.

The femoral cement compactor. An improvement in cementing technique in total hip replacement.

Aseptic loosening is the most common cause of femoral component failure in total hip arthroplasty. Even with new cementing techniques, bone-cement pressurization is low in the most proximal area of the femoral canal. To correct this problem, we devised the femoral cement compactor. This device increased the pressurization of bone cement in the proximal area of the femur by 71 per cent and increased the duration of the pressurization fourfold as compared with the results achieved by finger-packing methods. Pressurization of the cement was also increased in the middle and distal areas of the proximal portion of the femoral canal. These findings suggest that using the femoral cement compactor may contribute to improved cement fixation of the femoral component during total hip replacement.

Intra-articular acetabular labrum: a possible etiological factor in certain cases of osteoarthritis of the hip.

In eight patients with so-called idiopathic degenerative arthritis of the hip the acetabular labrum, at surgery, was found to lie in the articulation between the femoral head and the acetabulum. In none of the patients was there a history or roentgenographic evidence of congenital dysplasia or congenital dislocation. None of the patients had had a closed reduction or manipulation of the hip during infancy, childhood, or adolescence. No patient had had a traumatic dislocation. The findings suggest that the intra-articular labrum was a developmental abnormality and we postulate that this abnormality was the cause of the degenerative arthritis.

The Miller-Galante knee prosthesis for the treatment of osteoarthrosis. A comparison of the results of partial fixation with cement and fixation without any cement.

In a prospective, non-randomized study of 344 patients who had 392 primary total knee replacements with a Miller-Galante I prosthesis for the treatment of osteoarthrosis, the results of partial fixation with cement (insertion of the tibial and patellar components with cement and of the femoral component without cement) were compared with those of fixation without any cement. Of the 392 knees, 183 (163 patients) had fixation without cement (Group I) and 209 (181 patients), with and without cement (Group II). The average duration of follow-up was three years (range, two to five years). Nine patients died during the follow-up period, but no others were lost to follow-up. Analysis of the knee scores, range of motion of the knee, radiographs, and rates of complications revealed no differences between the outcomes in the two groups during the follow-up period. The rate of complications due to problems related to the extensor mechanism was high in both groups: a reoperation was performed in fifteen (8 per cent) of the knees that had had fixation without cement and in nineteen (9 per cent) of those that had had both types of fixation. Thirteen patients had additional operative treatment for recurrent patellar dislocations; twelve patients, for abnormal wear of the polyethylene of the patellar component: two patients, for avulsion of the patellar ligament from the tibia; and two patients, for unexplained pain in the knee. In addition, there were eight patellar fractures (two of which led to a reoperation) and three deep infections (all of which led to a reoperation).

The surgical treatment of exertional compartment syndrome in athletes.

We studied the cases of twelve patients who had bilateral exertional compartment syndrome involving one or all of the compartments of the lower extremities. The patients were divided into three groups based on the clinical findings. Group I consisted of seven patients with symptoms involving the anterior or lateral compartments only; Group II, of three patients with involvement of the deep posterior compartments alone; and Group III, of two patients with involvement of both the anterior and deep posterior compartments. On the basis of their clinical signs and symptoms each patient underwent dynamic tissue-pressure measurements using a slit catheter before, during, and for as long as thirty minutes after exercise. All patients had elevated resting and peak-to-peak dynamic pressure measurements. Treatment consisted of bilateral compartmental fasciotomy, as indicated. All of the patients in Group I had complete relief of symptoms; however, one patient in Group II and one in Group III had a recurrence of symptoms in the deep posterior compartment.

The effect of medial meniscectomy on strain distribution in the proximal part of the tibia.

The tibiae of five fresh adult human cadaver legs (amputated proximal to the knee) were instrumented with twenty-five strain-gauge rosettes and were tested in axial compression, simulating single-limb stance, at loads of as much as 2450 newtons. We compared the status of the normal knee, with menisci intact, with the status of the same knee after partial or total medial meniscectomy. The resultant changes in strain on the cortical bone of the tibia indicated that medial meniscectomy caused reduced compressive strains on the whole of the lateral aspect of the tibia, while on the medial aspect compressive strains were increased at all levels beyond seventy millimeters distal to the joint-line; however, within fifty millimeters of the joint-line on the medial aspect, there was a significant reduction of compressive strains.

A tapered titanium femoral stem inserted without cement in a total hip arthroplasty. Radiographic evaluation and stability.

The results of 416 total hip arthroplasties performed in 372 patients with insertion of a Mallory-Head titanium femoral component without cement were reviewed retrospectively, to determine the stability and the radiographic parameters of stability for this type of stem. The average duration of clinical and radiographic follow-up was 3.7 years (range, 2.0 to 6.5 years). No revisions were performed to treat instability of the stem, pain, or osteolysis by the time of the latest follow-up examination. Although the clinical results were excellent, the radiographic signs of fixation that have been well described for chromium-cobalt stems were frequently absent. So-called endosteal spot welds, commonly seen in association with long, extensively coated stems, were seen infrequently. Resorptive bone-remodeling rarely extended beyond zones 1 and 7 of Gruen et al. Both endosteal and periosteal distal cortical hypertrophy was common, but the cause was unknown. Osteolysis of the distal aspect of the femur, shedding of the porous coating, and breakage of the stem were not seen. Forty-four stems (11 per cent) had initial subsidence; however, it nearly always stabilized within six months postoperatively and did not affect the eventual stability at the time of the short-term follow-up. The short-term clinical outcome confirmed the stability of these stems that had been determined from the radiographic findings and the lack of revisions. At the latest follow-up examination, 323 (87 per cent) of the patients (362 [87 per cent] of the hips) had no or slight pain in the lower limb over-all and only twenty-two (6 per cent) of the patients (twenty-seven [6 per cent] of the hips) had pain in the thigh. This tapered titanium femoral component appears to provide excellent short-term stability, without resorptive bone-remodeling, osteolysis, or a high prevalence of pain in the thigh. Radiographic evaluation of stability of this stem is clearly different from that of chromium-cobalt stems-particularly extensively coated anatomic medullary locking stems-in that so-called spot welds and severe resorptive bone changes were uncommon and distal cortical hypertrophy was common.

Stability of ten configurations of the Hoffmann external-fixation frame.

The rigidity, load to yield, and load to failure of ten configurations of the Hoffmann external fixator were investigated using a model of wooden pylons with a simulated fracture that consisted of either a reduced transverse cut or a ten-millimeter gap. The axial compressive, torsional, anterior-posterior bending, and medial-lateral bending characteristics of four forms of the single half-frame (half-pinned), four double half-frame, and two full-frame (transfixion-pinned) configurations were examined. Of the single half-frame configurations, a system with a second stacked connecting-rod proved to be superior; however, the system yielded at a mean axial compressive load of only 199 newtons and failed totally at 355 newtons. The delta frame (two rods connecting or triangulating two half-frames set at an angle of 45 degrees to one another) was as rigid as the quadrilateral full frame in axial compression; however, it exhibited low loads to yield and to failure, with means around 200 and 350 newtons, respectively. The use of only two pins in each pin-cluster did not significantly affect the performance of the delta frame. The two full-frame systems performed poorly in torsion and particularly poorly in anterior-posterior bending. The loads that caused a one-millimeter movement within the fracture gap in axial compression were notably low: for the stacked half-frames the load did not exceed a mean value of 174 newtons; for the double half-frame, 190 newtons; and for the quadrilateral frame, 412 newtons. We concluded that no frame had a good over-all performance with regard to rigidity.(ABSTRACT TRUNCATED AT 250 WORDS)

Deep-vein thrombosis and continuous passive motion after total knee arthroplasty.

Seventy-five of 150 consecutive patients who underwent total knee arthroplasty had routine physiotherapy and seventy-five had continuous passive motion of the lower limb that had been operated on as well as routine physiotherapy. A pulmonary embolus did not develop in any patient, but about 40 per cent had thrombosis in the veins of the calf, whether passive motion had been administered or not. Radiographically, the deep-vein thrombosis was seen to extend into or proximal to the popliteal vessel in 5 per cent of the patients in each group. Sex, age, obesity, or a history of hypertension or diabetes did not influence the incidence of venous thrombosis, but there was a higher incidence in patients in whom cement was used for fixation of the total knee components, irrespective of the use of continuous passive motion of the limb.

Randomized trials in orthopaedics: why, how, and when?

There is increasing recognition that major new medical therapies should be rigorously evaluated before they are put into general clinical use. Randomized controlled trials provide the most unbiased assessment of the risks and benefits of such therapies. In this article, the most important aspects of the design and execution of a randomized clinical trial in orthopaedics are discussed. These include the reasons for and mechanisms of randomization, appropriate selection of patients and therapy, reasons for the blinding of therapy, types of measures of outcome that can be used, aspects of sample-size calculation and analysis of data, and ethics of randomized controlled trials.

Pain in the thigh following total hip replacement with a porous-coated anatomic prosthesis for osteoarthrosis. A five-year follow-up study.

We performed a study to determine the prevalence, severity, and natural history of pain in the thigh in patients who had a total hip replacement with a porous-coated anatomic prosthesis and to determine if there was an association between the radiographic findings and the pain in the thigh. We previously reported the results in these patients two years after the operation. The present study included ninety-four patients (101 total hip replacements) who had been followed for a minimum of five years--six of the original group of patients had died from unrelated causes, two had had a revision, and one had been lost to follow-up. The patients were assessed prospectively with use of the Harris hip score and a visual-analog scale for pain in the thigh. Two of us, who were blinded to the clinical result, reviewed the radiographs retrospectively for the morphology of the proximal aspect of the femur; distal fit; metaphyseal fill; alignment of the stem; shedding of beads; distal cortical hypertrophy; pedestal formation; cancellous condensations at the distal end of the porous ingrowth surface; and the presence, extent, and location of radiolucent lines around the femoral component. At five years, pain in the thigh was found in association with twenty-seven hips (27 per cent). The pain was new in fourteen thighs (14 per cent), unchanged (from that at the two-year follow-up examination) in eight (8 per cent), increased in four (4 per cent), and decreased in one (1 per cent). Pain in the thigh was most strongly associated with a poor Harris hip score and the presence of loose beads.

Topical hemostatic agents for bone bleeding in humans. A quantitative comparison of gelatin paste, gelatin sponge plus bovine thrombin, and microfibrillar collagen.

The three topical hemostatic agents--gelatin paste, microfibrillar collagen, and gelatin sponge soaked in thrombin--individually were effective in reducing bleeding from cancellous bone, as tested on the femoral surface of trochanteric osteotomies during total hip replacement. During a three-minute interval, the spontaneous reduction in bleeding in eight control hips to which no agent was applied was 11 per cent. Gelatin paste gave a reduction of 85 per cent; gelatin sponge soaked in thrombin, a reduction of 75 per cent; and microfibrillar collagen, a reduction of 47 per cent. None of these agents interfered with healing of the trochanteric osteotomy.

The Harris Design-2 total hip replacement fixed with so-called second-generation cementing techniques. A ten to fifteen-year follow-up.

We analyzed the clinical results of 195 Harris Design-2 total hip replacements performed with so-called second-generation cementing techniques in 166 consecutive patients who had osteoarthrosis. The mean age of the patients at the time of the replacement was sixty-seven years and nine months (range, thirty-one to eighty-nine years). Forty-eight patients (fifty-four hips) died before the time of the latest follow-up, but the implants were apparently functioning well at the time of death. Three patients (four hips) were lost to follow-up. Five patients (five hips; 3 percent) had a revision because of aseptic loosening of the acetabular or femoral component, or both, that was related to wear-induced osteolysis. The mean Harris hip score for the 131 hips that were available at the latest follow-up examination at a mean of twelve years (range, ten to fifteen years) after the operation was 89 +/- 10 points. On the basis of the Harris hip score, seventy-six hips had an excellent result, thirty-four had a good result, fifteen had a fair result, and six had a poor result at the latest follow-up examination. Radiographically, twelve (9 percent) of the 131 acetabular components and three (2 percent) of the 131 femoral components were probably or definitely loose. At a mean of twelve years, 186 (97 percent) of 191 Harris Design-2 implants were in situ or had been in situ at the time of the patient's death.

Intra-articular injection of bupivacaine in knee-replacement operations. Results of use for analgesia and for preemptive blockade.

The effectiveness of an intra-articular injection of bupivacaine, administered before the incision or after closure of the wound, was studied in an effort to decrease the need for postoperative narcotics and to improve analgesia for patients who have elective knee replacement. Eighty-two patients received two intra-articular injections in a random, double blind fashion. Twenty-eight of them received thirty milliliters of 0.5 percent bupivacaine and 1:200,000 epinephrine in saline solution before the incision and an injection of thirty milliliters of plain saline solution after closure of the wound (Group 1). Twenty-seven patients received an injection of thirty milliliters of plain saline solution before the incision and thirty milliliters of 0.5 percent bupivacaine and 1:200,000 epinephrine in saline solution after closure of the wound (Group 2). Twenty-seven patients were given thirty milliliters of plain saline solution (a placebo) for both injections (Group 3). The patients who had received bupivacaine after closure of the wound (Group 2) used less morphine from the patient-controlled analgesia pumps than the patients who had received bupivacaine before the incision (Group 1) and the patients who had received the placebo (Group 3). In the first twenty-four hours after the operation, the administration of morphine (mean and standard deviation) was 59 +/- 27 milligrams for Group 2 compared with 68 +/- 30 milligrams for Group 1 (p = 0.26) and 81 +/- 30 milligrams for Group 3 (p = 0.006). At the time of discharge from the hospital, the patients in Group 2 also had a significantly greater mean range of motion (85.2 +/- 8.0 degrees) compared with that of the patients in Groups 1 (80.6 +/- 6.8 degrees, p = 0.02) and 3 (80.1 +/- 6.2 degrees, p = 0.009). However, there was no difference among the groups with respect to the effectiveness of the analgesia, as measured with use of either the visual-analog or the verbal pain-rating scale, or in the prevalence of side effects, including somnolence, urinary retention, nausea and vomiting, or pruritus. Serum concentrations of bupivacaine were well below toxic levels. It was our conclusion that that and intra-articular injection of thirty milliliters of 0.5 percent bupivacaine and 1:200,000 epinephrine in saline solution after closure of the wound decreases the need for narcotics and increases the range of motion after an elective knee replacement. The clinical importance of the amount of increased motion is questionable and needs long-term monitoring.

Tibial post wear in posterior stabilized total knee arthroplasty. An unrecognized source of polyethylene debris.

BACKGROUND: With extensive use of posterior stabilized total knee arthroplasty implants, it is increasingly important to assess the mechanical performance of this design alternative. The purpose of this study was to examine the wear patterns at the femoral cam-tibial post interface in a series of posterior stabilized prostheses retrieved at revision arthroplasty. METHODS: Qualitative and quantitative wear analysis was performed over the surface of the stabilizing posts from twenty-three retrieved total knee components that had been implanted for a mean of 35.6 months (range, 2.3 to 107.2 months). The implants were designs from four different manufacturers. Digital images of the anterior, posterior, medial, and lateral surfaces of the tibial post were made for quantitative analysis and determination of a post wear score. Wear was characterized with a grading system that isolates adhesive, abrasive, and fatigue wear, inferring a weighted score from an estimation of generated polyethylene debris. RESULTS: Evidence of wear or damage was observed on all twenty-three of the stabilizing posts, including those revised because of infection. On the average, 39.9% (range, 18.5% to 60%) of the post surface demonstrated some form of deformation, with adhesive wear, or burnishing, being the predominant wear mechanism. Seven posts (30%) exhibited severe damage with gross loss of polyethylene. The wear caused premature failure and early revision of two components: one of these failures was related to isolated post wear and the other, to severe post wear and subsequent fracture. Overall, wear was primarily posterior, but wear over the anterior, medial, and lateral surfaces was also notable. CONCLUSIONS: The cam-post articulation in posterior stabilized implants can be an additional source of polyethylene wear debris. The variability in wear patterns observed among designs may be due to differences in cam-post mechanics, post location, and post geometry. The surgeon should be aware that the cam-post interface is not an innocuous articulation, and manufacturers should be motivated to produce implants that maintain the function of the post while limiting wear and surface damage.

The porous coated anatomic total hip replacement. A ten to fourteen-year follow-up study of a cementless total hip arthroplasty.

BACKGROUND: We previously reported our two and five-year results of arthroplasty with the Porous Coated Anatomic total hip prosthesis. We now report on the performance of this prosthesis at ten to fourteen years. METHODS: The results of 311 total hip replacements in which a Porous Coated Anatomic prosthesis was inserted without cement in 279 patients were analyzed prospectively. The average age of the patients at the time of the replacement was sixty--one years (range, twenty to eighty-one years). Sixty-four patients (seventy-six hips) died postoperatively. Forty-five patients (forty-seven hips) were lost to follow-up, and four were excluded because of their medical condition. One hundred and sixty-eight patients (187 hips) were followed for ten to fourteen years (average, twelve years). Seventeen of those patients (seventeen hips) had a revision. RESULTS: The overall survival rate (with any revision as the end point) was 90.0% +/- 5.4% at fourteen years, with an average Harris hip score of 85 +/- 14 points. The prevalence of thigh pain was 36% (fifty-six of 157) in the late period (more than ten years postoperatively). Radiographs showed stable fixation, with bone ingrowth, of 83% (130) of the 156 acetabular components and 88% (137) of the 156 femoral components at the latest follow-up evaluation. Men had a significantly higher rate of femoral osteolysis than did women (p < 0.001). The rates of acetabular and femoral osteolysis associated with 32-mm femoral heads (49% [twenty-three] of forty-seven and 70% [thirty-three] of forty-seven, respectively) were significantly higher (p < 0.01) than those associated with 26-mm heads (26% [twenty-eight] of 109 and 30% [thirty-three] of 109, respectively). Despite this, revision (removal or exchange of components) was not directly related to head size; instead, it was related to polyethylene thickness. CONCLUSIONS: There have been persistent problems with the Porous Coated Anatomic hip system, including thigh pain and an increasing prevalence of osteolysis with time. Revision because of aseptic loosening was related more to the thickness of the polyethylene liner than to the size of the femoral head. Femoral heads with a 32-mm diameter did not increase the risk for revision provided that an adequate thickness of polyethylene had been used.

Measurement of polyethylene wear in acetabular components inserted with and without cement. A randomized trial.

We measured the three-dimensional wear of polyethylene after total hip arthroplasty with a titanium metal-backed Mallory-Head prosthesis that was inserted with cement in sixty-nine patients (sixty-nine hips) and with a press-fit titanium metal-backed Mallory-Head prosthesis that was inserted without cement in seventy patients (seventy hips). A modular titanium femoral head was used in all of the hips. The patients in the present study were part of a larger double-blind randomized trial comparing the result of total hip arthroplasty performed with cement with that of the same procedure performed without cement in 250 patients. The criterion for inclusion in the study of polyethylene wear was a minimum duration of follow-up of four years, which was met by 148 patients. As adequate radiographs for digitization were not available for nine patients, 139 patients were included in the present study. The age of the patient, the postoperative Harris hip score, the diameter of the femoral head, the thickness of the liner in the polar region of the acetabular component, and the duration of follow-up were similar for the two groups. The mean rate of volumetric wear of the polyethylene was significantly greater in the prostheses that had been inserted without cement than in those that had been inserted with cement (155.1 cubic millimeters per year compared with 98.5 cubic millimeters per year; p = 0.000008). Thirty-four (49 per cent) of the seventy hips in which the prosthesis had been inserted without cement had evidence of osteolysis on radiographs, compared with twelve (17 per cent) of the sixty-nine hips in the other group (p = 0.0002). Osteolysis was associated with an increased rate of polyethylene wear only in the hips in which the prosthesis had been inserted without cement.