Clinical Results and Survivorship of the GENESIS II Total Knee Arthroplasty at a Minimum of 15 Years.

BACKGROUND: The purpose of this study was to examine the 15-year survivorship and long-term clinical outcomes of the GENESIS II total knee arthroplasty (TKA). METHODS: Patients who underwent TKA with the GENESIS II system between 1995 and 1999 were retrieved from our institutional database. We report a Kaplan-Meier survival analysis as well as Western Ontario and McMaster Universities Arthritis Index, the Short Form Health Survey-12 (SF-12), and the Knee Society Scores at a mean of 16 years. RESULTS: Four-hundred sixty-nine TKAs were performed with a mean patient age of 68 years. Patients were followed up prospectively for a mean of 16 years (range, 14.8-19.5 years). The Kaplan-Meier survival analysis at 15 years, with revision for any reason as the end point, was 96.4% (95.5%-97.3%). The Western Ontario and McMaster Universities Arthritis Index and the Knee Society Scores were significantly improved (P < .001) from the preoperative period to the latest follow-up. Patients had a significant improvement (P < .001) from the preoperative to the latest follow-up on the Physical Health Composite Score of the SF-12, but no change was noted on the Mental Health Composite Score of the SF-12. CONCLUSION: The unique design features of the GENESIS II TKA system have remained a constant over the duration of its clinical use, a rarity for contemporary TKA systems which are often altered before the publication of long-term results. The GENESIS II continues to demonstrate excellent long-term survivorship and improvements in health-related outcomes at a mean of 15 years, representing the standard for TKA systems at our institution.

The Knee Society Short Form Reduces Respondent Burden in the Assessment of Patient-reported Outcomes.

BACKGROUND: The patient's own evaluation of function and satisfaction is a fundamental component of assessing outcomes after total knee arthroplasty (TKA). The new Knee Society Knee Score was introduced in 2012 and has been shown to be a valid and reliable instrument for measuring the outcome of TKA. This score combines an objective, physician-derived component and a patient-reported component to characterize the expectations, satisfaction, and functional activities of diverse lifestyles of contemporary patients undergoing TKA. However, in the routine clinical setting, the administration and scoring of outcome measures is often resource-intensive, as the expenditure of time and budget for outcome measurement increase with the length and complexity of the instrument used, and so a short-form assessment can help to reduce the burden the assessment of outcomes. QUESTIONS/PURPOSES: The purposes of this study were (1) to develop a short-form version of the new Knee Society Knee Score; (2) to validate the short form against the full Knee Society Knee Score; and (3) to evaluate the responsiveness to treatment (TKA) of the new Knee Society short-form assessment. METHODS: To develop the short form, data from the sample of 497 patients recruited during validation of the original long form the new Knee Society Knee Score were used. The multicenter study was approved by the institutional review boards at 15 participating medical institutions within the United States and Canada. An analytic item reduction approach was applied simultaneously but separately to preoperative and postoperative patient-reported data to select a subset of items from the original form that had good measurement properties and closely reflected the scores obtained using the original form. RESULTS: Expectations and satisfaction were reflected by a single item in the newly developed short form compared with a total of five satisfaction and three expectation items in the long form. The functional activities subscale was reduced from 17 to six items. An excellent correlation was demonstrated between function scores derived from the functional activities subscale of the original long-form score (17 items) and the six-item short form (r = 0.97; p < 0.01). The sample mean difference between the two scores was less than 4 points with a SD of 6.7 points. The short form was capable of discriminating clinically different groups of patients before and after TKA with virtually the same estimated effect size as the original functional activities subscale of the new Knee Society Knee Score. CONCLUSIONS: The Knee Society Knee Score long form is still recommended for research studies and for more sensitive measurement of the outcomes of individual patients. However, for general clinical use with large patient populations, the short form is expected to improve the rate of patient completion while also being easier to administer. In this study, we found the short-form version of the Knee Society Knee Score to be practical, valid, reliable, and responsive for assessing the functional outcome of TKA.

Joint replacement recipients' views about health information privacy.

BACKGROUND: Researchers are concerned about the possibility of restricted access to data as a result of specific consent requirements in privacy legislation, potentially resulting in smaller samples and a lack of representativeness which could bias results. In addition, there is uncertainty about what influences individuals to give consent for the use of their personal health information. OBJECTIVE: To measure joint replacement recipients' health information privacy views and to assess potential predictors of these views. DESIGN: Cross-sectional survey. SETTING AND PARTICIPANTS: Potential joint replacement recipients from two teaching hospitals in London, Ontario, Canada. MAIN VARIABLES: Age, gender, education, employment status, anticipated joint replacement, and expectations for surgery. MAIN OUTCOME MEASURES: Privacy concerns as measured by the Concern Scale. RESULTS: The response rate was 182/253 or 72%. The mean Concern score was 143.9/235.0 for the total sample (range = 82-216). Women had higher levels of privacy concerns than men on slightly over half of the individual questionnaire items. In women, surgical joint, age and employment explained 15% of the variance in concerns about personal health information privacy (P = 0.001). The model explained 6% of the variance in concerns in men (P = 0.138) and was not statistically significant. DISCUSSION AND CONCLUSION: This study indicates that demographic characteristics and health-care experiences play a role in the variability of health information privacy concerns. A greater understanding of patients' privacy views about health information could lead to a greater harmonization among privacy rules, research and data access, and the preferences of health-care consumers.

Ten-year results comparing posterior cruciate-retaining versus posterior cruciate-substituting total knee arthroplasty.

We compared the 10-year survival rates and clinical outcomes of posterior cruciate-retaining (CR) versus posterior cruciate-substituting (CS) total knee arthroplasty (TKA), using the Genesis II knee system (Smith and Nephew, Memphis, TN). Our institutional database identified patients undergoing a primary knee with the Genesis II system between 1995 and 2000. These patients were followed for an average of 12.3years (range 10.2-14.4years). There were 143 (34.5%) CR and 271 (65.5%) CS implants. No significant difference in 10-year survivorship was noted between the two cohorts. The postoperative clinical scores (KSCRS, WOMAC, SF-12) and knee ROM were significantly better for the CS cohort. In this large, long-term, single-implant prospective study, CS performed better than CR in terms of clinical scores and range of motion.

Development of a Modern Knee Society Radiographic Evaluation System and Methodology for Total Knee Arthroplasty.

To accompany the new clinical Knee Society Score, a committee was formed to develop an updated radiographic assessment and evaluation system. The purpose is to accumulate radiographic data in a standardized manner to facilitate more accurate interpretation, documentation and clinical correlation. We systematically reviewed the TKA radiographic evaluation literature as well as the original Knee Society Radiographic Evaluation and Scoring System. A modern system was developed, approved by the Knee Society membership, which ensured proper radiographic documentation of coronal and sagittal implant alignment, fixation interface integrity with respect to radiolucent lines and osteolysis, and a zonal classification system to document precise deficiency locations. It is hoped that data may be accumulated in a standardized manner with eventual formulation of implant risk "criteria" or "scores'.

Radiographic Evaluations of Revision Total Knee Arthroplasty: A Plea for Uniform Assessments.

Thorough radiographic evaluation is necessary for perioperative assessments in revision total knee arthroplasty. There has been a large degree of variability in reporting these findings within the peer-reviewed literature. Our purpose was to evaluate studies that radiographically assessed alignment in the coronal and sagittal plane, patella alignment and thickness, presence and characterization of implant interface, and radiolucency. Secondly, we reviewed studies using a standardized reporting system to evaluate radiographic findings (the Knee Society Roentgenographic Evaluation and Scoring System) and the number of times it was referenced. Only 62% of studies evaluated all radiographic parameters, 57% to 91% assessed each metric, and 55% used standardized reporting systems. This emphasizes the need for a uniform evaluation method to ensure consistent radiographic assessment and optimal standard of care.

Feasibility, effectiveness and costs associated with a web-based follow-up assessment following total joint arthroplasty.

The purpose of this study was to assess the feasibility, effectiveness and costs of a web-based follow-up compared to in-person assessment following primary total hip or total knee arthroplasty. Patients who were at least 12 months postoperative were randomized to follow-up method. We excluded patients who had revision surgery, osteolysis, complications or identified radiographic issues. 229 patients (118 Web, 111 in-person) completed the study. There were no patients who had an issue missed by the web-based follow-up. Patients in the web-based group travelled less (28.2km vs 103.7km, (P<0.01)), had lower associated costs ($10.45 vs $21.36, (P<0.01)) and took less time to complete (121.7min web vs 228.7min usual). Web-based follow-up is a feasible, clinically effective alternative with lower associated costs than in-person clinic assessment.

The fate of the remaining knee(s) or hip(s) in osteoarthritic patients undergoing a primary TKA or THA.

The purpose of this study was to determine the fate of the remaining hip(s) and knee(s) following an initial total hip or knee arthroplasty in 5352 patients with idiopathic osteoarthritis who were followed for a minimum ten years (mean 17.8 ± 5.7 years). Following an initial primary TKA, 46.0% of patients had a contralateral TKA, 2.3% had an ipsilateral THA and 1.3% had a contralateral THA. Following an initial primary THA, 30.5% of patients had a contralateral THA, 6.8% had an ipsilateral TKA and 2.9% had a contralateral TKA. Cox regression analysis demonstrated that BMI was the sole risk factor for a second THA, but both age less than sixty years and a higher BMI were significant factors for patients requiring an additional primary TKA.

A randomized trial comparing acetabular component fixation of two porous ingrowth surfaces using RSA.

Several new porous ingrowth surfaces for acetabular component fixation have recently been developed. The purpose of this study was to compare the in vivo fixation achieved by two different porosity ingrowth surfaces using radiostereometric analysis (RSA). Sixty-two patients undergoing primary total hip arthroplasty (THA) were randomized to receive a cementless acetabular component with either a 61% high porosity asymmetric titanium porous surface (StikTite, Smith and Nephew, TN, USA) or a 45% low porosity sintered bead porous surface (Roughcoat, Smith and Nephew, TN, USA). RSA and clinical follow-up examinations were done post-operatively, 6-weeks, 3-months, 6-months, 1-year and 2-years. Both the high porosity StikTite and lower porosity Roughcoat surfaces provided excellent biologic fixation.

Measurement of joint kinematics using a conventional clinical single-perspective flat-panel radiography system.

PURPOSE: The ability to accurately measure joint kinematics is an important tool in studying both normal joint function and pathologies associated with injury and disease. The purpose of this study is to evaluate the efficacy, accuracy, precision, and clinical safety of measuring 3D joint motion using a conventional flat-panel radiography system prior to its application in an in vivo study. METHODS: An automated, image-based tracking algorithm was implemented to measure the three-dimensional pose of a sparse object from a two-dimensional radiographic projection. The algorithm was tested to determine its efficiency and failure rate, defined as the number of image frames where automated tracking failed, or required user intervention. The accuracy and precision of measuring three-dimensional motion were assessed using a robotic controlled, tibiofemoral knee phantom programmed to mimic a subject with a total knee replacement performing a stair ascent activity. Accuracy was assessed by comparing the measurements of the single-plane radiographic tracking technique to those of an optical tracking system, and quantified by the measurement discrepancy between the two systems using the Bland-Altman technique. Precision was assessed through a series of repeated measurements of the tibiofemoral kinematics, and was quantified using the across-trial deviations of the repeated kinematic measurements. The safety of the imaging procedure was assessed by measuring the effective dose of ionizing radiation associated with the x-ray exposures, and analyzing its relative risk to a human subject. RESULTS: The automated tracking algorithm displayed a failure rate of 2% and achieved an average computational throughput of 8 image frames/s. Mean differences between the radiographic and optical measurements for translations and rotations were less than 0.08 mm and 0.07° in-plane, and 0.24 mm and 0.6° out-of-plane. The repeatability of kinematics measurements performed using the radiographic tracking technique was better than ±0.09 mm and 0.12° in-plane, and ±0.70 mm and ±0.07° out-of-plane. The effective dose associated with the imaging protocol used was 15 µSv for 10 s of radiographic cine acquisition. CONCLUSIONS: This study demonstrates the ability to accurately measure knee-joint kinematics using a single-plane radiographic measurement technique. The measurement technique can be easily implemented at most clinical centers equipped with a modern-day radiographic x-ray system. The dose of ionizing radiation associated with the image acquisition represents a minimal risk to any subjects undergoing the examination.

How do CAD models compare with reverse engineered manufactured components for use in wear analysis?

BACKGROUND: To accurately quantify polyethylene wear in retrieved arthroplasty components, the original geometry of the component must be estimated accurately using a reference geometry such as a computer-aided design (CAD) model or a never-implanted insert. However, differences may exist between the CAD model and manufactured inserts resulting from manufacturing tolerances. QUESTIONS/PURPOSES: We quantified the deviations between CAD models and newly manufactured inserts and determined how these deviations compared with using a never-implanted insert as a reference geometry. METHODS: We obtained five cruciate-retaining (CR) and five posterior-stabilizing (PS) tibial inserts and their CAD models. The inserts were scanned and reconstructed using microcomputed tomography (micro-CT). Differences in volume and surface geometry were measured among (1) the individual inserts; (2) between the inserts and a CAD model; and (3) between the inserts and a reference geometry constructed from multiple scanned inserts averaged together. RESULTS: The micro-CT volumes were, on average, 0.4% smaller (34-178 mm(3)) than the CAD model volumes. The mean deviation between the CAD model and insert surface geometry was 25.7 µm smaller for CR and 36.8 µm smaller for PS. The mean deviation between the inserts and an averaged reference geometry was 1.4 µm larger for CR and 0.4 µm smaller for PS. CONCLUSIONS: Deviations exist between manufactured tibial inserts and CAD models that could cause errors in wear measurements. Scanned inserts may better represent the preimplantation geometry of worn inserts than CAD models, depending on the manufacturing variability between lots. CLINICAL RELEVANCE: The magnitude of the error in estimation of the preimplantation geometry of a retrieved component could add or subtract the equivalent of 1 year of wear.

Development of a new Knee Society scoring system.

BACKGROUND: The Knee Society Clinical Rating System was developed in 1989 and has been widely adopted. However, with the increased demand for TKA, there is a need for a new, validated scoring system to better characterize the expectations, satisfaction, and physical activities of the younger, more diverse population of TKA patients. QUESTIONS/PURPOSES: We developed and validated a new Knee Society Scoring System. METHODS: We developed the new knee scoring system in two stages. Initially, a comprehensive survey of activities was developed and administered to 101 unilateral TKA patients (53 women, 48 men). A prototype knee scoring instrument was developed from the responses to the survey and administered to 497 patients (204 men, 293 women; 243 postoperatively, 254 preoperatively) at 15 medical institutions within the United States and Canada. Objective and subjective data were analyzed using standard statistical and psychometric procedures and compared to the Knee Injury and Osteoarthritis Score and SF-12 scores for validation. Based on this analysis, minor modifications led to the new Knee Society Scoring System. RESULTS: We found the new Knee Society Scoring System to be broadly applicable and to accurately characterize patient outcomes after TKA. Statistical analysis confirmed the internal consistency, construct and convergent validity, and reliability of the separate subscale measures. CONCLUSIONS: The new Knee Society Scoring System is a validated instrument based on surgeon- and patient-generated data, adapted to the diverse lifestyles and activities of contemporary patients with TKA. This assessment tool allows surgeons to appreciate differences in the priorities of individual patients and the interplay among function, expectation, symptoms, and satisfaction after TKA.

Results of cemented femoral revisions for periprosthetic femoral fractures in the elderly.

The treatment goals of Vancouver type B2 periprosthetic femoral fractures in elderly patients with a limited life expectancy are early weight bearing without compromising the fracture healing. Thirty-one patients with a mean age of 82 years were treated with a long cemented stem with additional allograft or plate fixation, followed by immediate full weight bearing. Seven major complications occurred within the first 3 months postoperatively. Forty-three percent of patients had died within the first year with their implant in place. Sixteen patients had survived more than 1 year. None of the implants had to be revised at a mean follow-up of 46 months. The results of this series suggest that this technique can provide acceptable results and offers the advantages of reduced cost and early weight bearing.

The minimum 10-year results of a second-generation cementless acetabular shell with a polished inner surface.

The purpose of this prospective study was to evaluate the minimum 10-year outcomes and survivorship of the Reflection shell with a polished inner surface and an improved locking mechanism. Three hundred sixty-three total hip replacements with a mean follow-up of 11.6 years (range, 10.0-15.1) were evaluated. The mean Harris Hip and WOMAC scores at last follow-up were 87 and 77, respectively. Four cups were revised: 2 for infection and 2 for aseptic loosening. Thirteen cases underwent liner exchange for wear. Radiographic review of remaining cups identified 8.8% with identifiable peri-acetabular osteolysis and no cases of loosening. The overall 10- and 15-year Kaplan-Meier survivorship was 94% and 90% for the total hip arthroplasty system while the survivorship of the shell remained 99.4% at 15 years.

What works best, a cemented or cementless primary total hip arthroplasty?: minimum 17-year followup of a randomized controlled trial.

BACKGROUND: Total hip arthroplasty (THA) has been associated with high survival rates, but debate remains concerning the best fixation mode of THA. QUESTIONS/PURPOSES: We conducted a randomized controlled trial (RCT) with 250 patients with a mean age of 64 years between October 1987 and January 1992 to compare the results of cementless and cemented fixation. PATIENTS AND METHODS: Patients were evaluated for revision of either of the components. One hundred twenty-seven patients had died (51%) and 12 (4.8%) were lost to followup. The minimum 17-year followup data (mean, 20 years; range, 17-21 years) for 52 patients of the cementless group and 41 patients of the cemented group were available for evaluation. RESULTS: Kaplan-Meier survivorship analysis at 20 years revealed lower survival rates of cemented compared with cementless THA. The cementless tapered stem was associated with a survivorship of 99%. Age younger than 65 years and male gender were predictors of revision surgery. CONCLUSIONS: The efficacy of future RCTs can be enhanced by randomizing patients in specific patient cohorts stratified to age and gender in multicenter RCTs. Including only younger patients might improve the efficacy of a future RCT with smaller sample sizes being required. A minimum 10-year followup should be anticipated, but this can be expected to be longer if the difference in level of quality between the compared implants is smaller. LEVEL OF EVIDENCE: Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Posterior condyle surface damage on retrieved femoral knee components.

Twenty-two retrieved femoral knee components were identified with posterior condyle surface damage on average at 99° flexion (range, 43°-135° flexion). Titanium alloy material transfer and abrasive surface damage were evident on cobalt-chromium alloy femoral components that were in contact with titanium alloy tibial trays. Surface damage on the retrieved Oxinium femoral components (Smith and Nephew, Inc, Memphis, Tenn) that were in contact with titanium alloy tibial trays showed gouging, associated with the removal and cracking of the oxide and exposure of the zirconium-niobium alloy substrate. Cobalt-chromium alloy femoral components that were in contact with cobalt-chromium alloy tibial trays showed abrasive wear. Contact between the femoral component and tibial tray should be avoided to prevent surface damage to the femoral condyles, which could potentially accelerate polyethylene wear in vivo.

Midterm results of 506 solid trispiked reflection cementless acetabular components for primary total hip arthroplasty.

The purpose of this prospective study was to evaluate the outcomes and survivorship of a trispiked, sintered bead-coated titanium shell with a polished inner surface, no screw holes, and an improved locking mechanism. A total of 506 total hip arthroplasties with a minimum 5-year follow-up were available for review at a mean of 7 years (range, 5-11 years). Three sockets (0.6%) were revised for reasons other than aseptic loosening, and 14 (2.8%) polyethylene liners were exchanged. There was no difference in revision rate between non-cross-linked and highly cross-linked liners (P = .4). There were no cases of radiographic loosening. Retroacetabular osteolysis was identified in 2%. The overall 5-year and 10-year Kaplan-Meier survivorship was 97.5% and 97.4%, respectively, whereas survivorship of the shell was 99.8%.

Comparing patient outcomes after THA and TKA: is there a difference?

UNLABELLED: Both primary total hip (THA) and knee (TKA) arthroplasty relieve pain, restore function, and increase mobility. Despite these successes, there is controversy as to whether THA or TKA provides greater or similar improvement. We therefore compared primary THA and TKA patient results in terms of (1) willingness to have surgery again; (2) WOMAC change score; (3) whether expectations were met; and (4) satisfaction. Patients undergoing primary THA were more willing to undergo their surgery again (THA 96%, TKA 89%), demonstrated greater WOMAC change scores, more frequently reported their expectations were met (THA 78%, TKA 70%), and expressed greater overall satisfaction (THA 89%, TKA 81%). In addition, patients undergoing THA expressed higher satisfaction with pain reduction while performing activities (ie, walking, stairs, and sitting/lying) and their ability to perform daily activities (ie, stairs, transportation, getting up, lying in bed, and light domestic duties) when compared with patients undergoing TKA. Our data suggest primary THA offers superior short-term outcomes when compared with primary TKA. LEVEL OF EVIDENCE: Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.

The role of polyethylene design on postoperative TKA flexion: an analysis of 1534 cases.

UNLABELLED: The range of motion after TKA depends on many patient, surgical technique, and implant factors. Recently, high-flexion designs have been introduced as a means of ensuring or gaining flexion after TKA. We therefore evaluated factors affecting postoperative flexion to determine whether implant design influences longterm flexion. We prospectively collected data on patients receiving a primary Genesis II total knee replacement with a minimum of 1-year followup (mean, 5.4 years; range, 1-13 years). We recorded pre- and postoperative outcome measures, patient demographics, and implant design (cruciate retaining [CR, n = 160], posterior stabilized [PS, n = 1177], high-flex posterior stabilized [HF-PS, n = 197]). Backward stepwise linear regression modeling identified the following factors affecting postoperative flexion: preoperative flexion, gender, body mass index, and implant design. Independent of gender, body mass index, and preoperative flexion, patients who received a HF-PS and PS design implant had a mean of 8 degrees and 5 degrees more flexion, respectively, than those who received a CR implant. Patients with low flexion preoperatively (<100 degrees) were more likely to gain flexion, whereas those with high flexion preoperatively (>120 degrees) were most likely to maintain or lose flexion postoperatively. Controlling for implant design, patients with high flexion preoperatively (>120 degrees) were more likely to gain flexion with the HF-PS design implant (HF-PS = 32.0%; PS = 15.1%; CR = 4.5%). LEVEL OF EVIDENCE: Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.

Patient satisfaction after total knee arthroplasty: who is satisfied and who is not?

UNLABELLED: Despite substantial advances in primary TKA, numerous studies using historic TKA implants suggest only 82% to 89% of primary TKA patients are satisfied. We reexamined this issue to determine if contemporary TKA implants might be associated with improved patient satisfaction. We performed a cross-sectional study of patient satisfaction after 1703 primary TKAs performed in the province of Ontario. Our data confirmed that approximately one in five (19%) primary TKA patients were not satisfied with the outcome. Satisfaction with pain relief varied from 72-86% and with function from 70-84% for specific activities of daily living. The strongest predictors of patient dissatisfaction after primary TKA were expectations not met (10.7x greater risk), a low 1-year WOMAC (2.5x greater risk), preoperative pain at rest (2.4x greater risk) and a postoperative complication requiring hospital readmission (1.9x greater risk). LEVEL OF EVIDENCE: Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.