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.

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 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).

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.

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.

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.

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.

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.

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.

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.

Pelvic stresses in vitro--II. A study of the efficacy of metal-backed acetabular prostheses.

Six embalmed human cadaveric hemi-pelves with their associated proximal femurs have been tested in vitro using 25 strain-gauge rosettes on each hemi-pelvis. Loads were applied up to 2.5 kN and principal stresses were computed from the principal strain data. Acetabular prostheses, cemented in place upon a cartilage-devoid but intact subchondral bone-plate, showed little change in stress-patterns when compared with the normal data, regardless of whether or not the component employed metal-backing. The use of 30 anchoring holes of 6.4 mm diameter, in the intact subchondral bone-plate, had little effect upon the stress-patterns, regardless of whether metal-backing was employed upon the prosthesis. When the subchondral bone-plate was removed, there were notable changes in the stress-pattern in the periacetabular region and on the medial wall of pelvis. The metal-backed prosthesis did not produce such notable changes as its plastic counterpart, when the subchondral bone-plate was removed. The use of a plastic prosthesis cemented in a Protrusio ring, in an acetabulum devoid of subchondral bone, produced notable changes in the stress-patterns in the whole periacetabular region and on the medial wall.

Thigh pain after cementless hip arthroplasty. Annoyance or ill omen.

A retrospective review of 148 consecutive porous-coated hip arthroplasties (PCA) showed an incidence of thigh pain of 13% one year after surgery, and 22% at two years. Positive correlations were made with femoral stem subsidence (greater than 2 mm) and with distal periosteal and endosteal bone formation. No positive correlations were made with parameters of bone quality or component fit. Resolution of pain occurred in one-third and an anti-inflammatory agent produced partial relief in two-thirds of the patients. We conclude that thigh pain is secondary to stem instability with distal stress transfer in the absence of stable proximal fixation.

Principles of revision total knee arthroplasty.

Revision total knee replacement is a demanding surgical exercise that requires close adherence to a number of guiding principles if clinical results are to be maximized and complications avoided. To achieve consistently good results in revision total knee replacement, considerable emphasis has to be placed on preoperative planning, surgical exposure, dealing with bone defects, and selecting a proper revision implant.

Mobile-bearing knee replacement: concepts and results.

In summary, if TKRs are to be performed in patients who are younger and more active than those who had the initial procedures in the 1970s and 1980s, better wear performance is imperative for long-term durability, especially if surgeons continue to consider the versatility associated with modular knee-replacement systems to be a necessity. At least with some designs, including the Oxford knee and the LCS knee, the results after a minimum follow-up of 10 years are comparable with the best results after arthroplasty with fixed-bearing designs in terms of wear, loosening, and osteolysis (Table 7). As with fixed-bearing designs, there are additional challenges in terms of optimizing bearing-surface conformity and improving kinematics. Improvements in future designs of mobile-bearing total knee replacements should include better control of bearing mobility patterns to reduce the prevalence of the abnormal kinematic motions that have been observed in fluoroscopic evaluations.

Isometric hip abductor strength following total hip replacement and its relationship to functional assessments.

Despite the rehabilitative emphasis on hip abductor strength following total hip replacement (THR), it is unclear how muscular strength is related to function. The purposes of this study were to examine changes in hip abductor strength during the first 6 months following THR and to determine the relationship between hip abductor strength and functional performances. Forty-three patients (mean age 64 +/- 7 years) completed strength assessments before surgery and at 1, 6, 12, and 24 weeks after surgery, and functional assessments before surgery and at 12 and 24 weeks after surgery. Both hip abductor strength and functional performance were significantly improved at each assessment (p < 0.01). The correlation between isometric hip abductor torques and the distance walked in 6 minutes was modestly high (r = 0.48-0.51; p < 0.01). This study provides baseline data for isometric hip abductor strength that can be used comparatively to assess patient progress and to help set clinical goals. Although strength is related to function, isometric measurements of strength should not be relied upon as the sole predictors of function in patients who have undergone THR.

Deformation of the cement mantle of tibial components following total knee arthroplasty: a laboratory study.

An in vitro model has been developed to measure in-plane strains of the cement mantle, sandwiched between the tibial component and the underlying cancellous bone following total knee arthroplasty. Maximal in-plane strains occurred in the cement mantle below the contact points between the femoral and tibial components. These strains were significantly reduced by increasing the thickness of the polyethylene and even more impressively by metal backing. Eccentric loading, by as little as 5 degrees, increased the strains in the loaded compartment by 26 per cent and decreased those in the unloaded compartment by 62 per cent. The addition of torsion to axial loading did not significantly alter the principal direct strains or the principal shear strains. Although surface-covering tibial components have been advocated, continuous support of the cortical rim did not appear to be important in reducing cement mantle strains. While other studies have emphasized the critical stresses that may occur in the polyethylene tibial components of total knee implants, this study highlights the potential for localized cement fatigue with improperly sized components or with eccentric loading.

Acetabular osteolysis with cementless cups: a 5 to 7 year follow-up.

We reviewed the results of 172 plasma-sprayed, titanium primary total hip arthroplasties inserted without cement and followed 5 to 7 years. Hips were replaced for a wide range of diagnoses and patient ages. No femoral components had been revised nor were considered unstable. Clinical results have been excellent; 88% of hips had either no or a slight amount of pain and only 5% of patients had thigh pain when specifically asked. Radiographically, this femoral component achieved stability after an initial subsidence in 9% of cases. Extensive femoral bone resorption was rare, and distal cortical hypertrophy was commonly seen. Pelvic osteolysis occurred in 16 (9%) cases and was considered major in 10 of these. It was the cause of failure of 3 acetabular components. Femoral endosteal lysis was not observed. We concluded that mechanical stability of the Mallory-Head titanium total hip prostheses is excellent. However, significant pelvic osteolysis has occurred commonly with this implant design, and will continue to pose major reconstructive problems in the future.

Results of the cementless Mallory-Head primary total hip arthroplasty: a 5 to 7 year review.

We reviewed the results of 172 plasma-sprayed, titanium primary total hip arthroplasties inserted without cement and followed 5 to 7 years. Hips were replaced for a wide range of diagnoses and patient ages. No femoral components had been revised nor were any considered unstable. Clinical results have been excellent; 88% of hips had either no or slight amount of pain and only 5% of patients had thigh pain when specifically asked. Radiographically, this femoral component achieved stability after an initial subsidence in 9% of cases. Extensive femoral bone resorption was rare, and distal cortical hypertrophy was commonly seen. Pelvic osteolysis occurred in 16 (9%) cases and was considered major in 10 of these. It was the cause of failure of 3 acetabular components. Femoral endosteal lysis was not observed. We concluded that mechanical stability of the Mallory-Head titanium total hip prostheses is excellent. However, significant pelvic osteolysis had occurred commonly with this implant design, and will continue to pose major reconstructive problems in the future.

Delamination wear on two retrieved polyethylene inserts after gamma sterilization in nitrogen.

Two self-aligning mobile bearing knee replacements (SAL-1) with gamma-in-nitrogen sterilized polyethylene inserts were revised due to instability after 6.3 years and after 14.2 years in vivo in two patients. The predominant damage features were burnishing, cracking, and delamination and were observed on the proximal bearing surface of the retrieved polyethylene inserts. This suggested an association with sub-surface fatigue, perhaps initiated by in vivo oxidative degradation which was confirmed by developing a sub-surface white band in one insert. The damage features observed on the distal bearing surface of the polyethylene inserts suggested both an adhesive wear mechanism and an abrasive wear mechanism. The titanium-nitrite coated, titanium-alloy tibial tray was severely worn in one case and possibly contributed to third-body abrasive wear at the distal surface interface. We suggest to carefully follow-up patients who received this type of mobile bearing knee system.

Randomised controlled trial comparing early migration of two collarless polished cemented stems using radiostereometric analysis.

This was a safety study where the hypothesis was that the newer-design CPCS femoral stem would demonstrate similar early clinical results and micromovement to the well-established Exeter stem. Both are collarless, tapered, polished cemented stems, the only difference being a slight lateral to medial taper with the CPCS stem. A total of 34 patients were enrolled in a single-blinded randomised controlled trial in which 17 patients received a dedicated radiostereometric CPCS stem and 17 a radiostereometric Exeter stem. No difference was found in any of the outcome measures pre-operatively or post-operatively between groups. At two years, the mean subsidence for the CPCS stem was nearly half that seen for the Exeter stem (0.77 mm (-0.943 to 1.77) and 1.25 mm (0.719 to 1.625), respectively; p = 0.032). In contrast, the mean internal rotation of the CPCS stem was approximately twice that of the Exeter (1.61 degrees (-1.07 degrees to 4.33 degrees ) and 0.59 degrees (0.97 degrees to 1.64 degrees ), respectively; p = 0.048). Other migration patterns were not significantly different between the stems. The subtle differences in designs may explain the different patterns of migration. Comparable migration with the Exeter stem suggests that the CPCS design will perform well in the long term.