A Randomized Clinical Trial Comparing Posterior Cruciate-Stabilizing vs Posterior Cruciate-Retaining Prostheses in Primary Total Knee Arthroplasty: 10-Year Follow-Up.

BACKGROUND: This 10-year follow-up compares health-related quality of life (HRQL) and reoperations in 100 subjects who were randomized to receive posterior cruciate ligament substituting (PS) or posterior cruciate ligament retaining (CR) total knee arthroplasty. We previously reported 2-year results. METHODS: Subjects were enrolled preoperatively and randomized at surgery. Subjects completed HRQL questionnaires at all evaluation points. Subjects were re-evaluated at 2 and 10 years with reoperations determined through regional medical record review and patient report. RESULTS: Over 10 years, 25 (25%) subjects died, 2 subjects were revised and withdrew, and 11 (11%) subjects were lost to follow-up. Of survivors, 62 of 75 (83%) were evaluated at 10 years. Twenty-eight (37%) subjects provided HRQL, radiographic, and reoperation status, 28 (37%) subjects completed HRQL evaluations and reoperation status only, and 6 (8%) subjects provided radiographic and reoperation follow-up. Both groups retained good HRQL between 2 and 10 years with no group differences noted (P > .35). One revision (CR subject), secondary to deep joint infection, occurred within 2 years with 1 further revision (PS subject) occurring at 3 years postoperatively. One subject (PS subject) required manipulation under anesthesia within 3 months of surgery. Four subjects required late patellar resurfacing (1 CR subject, 3 PS subjects) but were retained in the 10-year evaluation. Overall, reoperations were not significantly different between groups (P = .26). CONCLUSION: Over 10 years postoperatively, both the PS and CR total knee arthroplasty performed well with subjects reporting acceptable levels of HRQL up to 10 years postoperatively; low levels of revision or reoperation were reported in both groups.

Interobserver reliability of the radiographic assessment of cement fixation in total hip arthroplasty.

BACKGROUND: The objective of this work is to evaluate the performance of a modified quantitative Barrack Cement grading in primary THA. Previous studies demonstrated both poor intraobserver and interobserver reliability which may be due to the qualitative nature of the scale. METHODS: Interobserver reliability of the Barrack Cement Grading System in its original format and then in combination with a quantitative measurement of implant/cement lengths was evaluated on 50 immediate post-operative radiographs of primary cemented arthroplasties. Intraobserver reliability was also assessed on a sub-sample of radiographs. Three evaluators with different skill levels and specialty participated: an arthroplasty surgeon, an orthopaedic resident and a radiologist. Reliability was measured using a weighted kappa coefficient for paired comparisons among the evaluators. RESULTS: Interobserver reliability was poor (κ < 0.10) for all pairings of the Barrack System. The modified quantitative system achieved slight (κ < 0.20) to poor reliability. Intraobserver reliability was dependent on the skill and specialty of the evaluator with maximal values achieved for the experienced arthroplasty surgeon using the modified quantitative system (κ = 0.62). CONCLUSION: Use of the modified scale may improve the reliability of ratings when used by individual experienced arthroplasty surgeons.

A randomized trial of ceramic-on-ceramic bearing versus ceramic-on-crossfire-polyethylene bearing in total hip arthroplasty: five-year outcomes.

This study determined how ceramic-on-ceramic bearing THA affected joint-specific pain, function and stiffness in the first five postoperative years compared with ceramic-on-highly-crosslinked-polyethylene bearing THA. Subjects less than 61 years of age were randomized to ceramic-on-ceramic (CERAMIC) [n = 48] or ceramic-on-highly-crosslinked-polyethylene (POLYETHYLENE) [n = 44] bearing THA. Subjects were assessed using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and the RAND 12-Item Health Survey (RAND-12) preoperatively, and at one and five years postoperatively. 92 subjects(50 (54%) males; average age = 52 (SD 6.6) years) were enrolled. 78 (85%) subjects returned five years postoperatively. All subjects reported improvements at one and five years in all measured indices with no group differences detected. Seven (8%) subjects experienced postoperative THA complications, none related to bearing surfaces; two subjects (POLYETHYLENE) required revision for instability. Both bearing surfaces provided excellent short-term results in younger subjects.

Comparative effectiveness of alternative clinical pathways for primary hip and knee joint replacement patients: a pragmatic randomized, controlled trial.

OBJECTIVE: Total hip replacement (THR) and total knee replacement (TKR) (arthroplasty) surgery for end-stage osteoarthritis (OA) are ideal candidates for optimization through an algorithmic care pathway. Using a comparative effectiveness study design, we compared the effectiveness of a new clinical pathway (NCP) featuring central intake clinics, dedicated inpatient resources, care guidelines and efficiency benchmarks vs. the standard of care (SOC) for THR or TKR. METHODS: We compared patients undergoing primary THR and TKR who received surgery in NCP vs. SOC in a randomised controlled trial within the trial timeframe. 1,570 patients (1,066 SOC and 504 NCP patients) that underwent surgery within the study timeframe from urban and rural practice settings were included. The primary endpoint was improvement in Western Ontario and McMaster University osteoarthritis index (WOMAC) overall score over 12 months post-surgery. Secondary endpoints were improvements in the physical function (PF) and bodily pain (BP) domains of the Short Form 36 (SF-36). RESULTS: NCP patients had significantly greater improvements from baseline WOMAC scores compared to SOC patients after adjusting for covariates (treatment effect=2.56; 95% confidence interval (CI) [1.10-4.01]). SF-36 BP scores were significantly improved for both hip and knee patients in the NCP (treatment effect=3.01, 95% CI [0.70-5.32]), but SF-36 PF scores were not. Effects of the NCP were more pronounced in knee patients. CONCLUSION: While effect sizes were small compared with major effects of the surgery itself, an evidence-informed clinical pathway can improve health related quality of life (HRQoL) of hip and knee arthroplasty patients with degenerative joint disorder in routine clinical practice for up to 12 months post-operatively. CLINICALTRIALS.GOV IDENTIFIER: NCT00277186.

A randomized controlled trial comparing patellar retention versus patellar resurfacing in primary total knee arthroplasty: 5-10 year follow-up.

BACKGROUND: The primary purpose of this randomized controlled trial (RCT) was to compare knee-specific outcomes (stiffness, pain, function) between patellar retention and resurfacing up to 10 years after primary total knee arthroplasty (TKA). Secondarily, we compared re-operation rates. METHODS: 38 subjects with non-inflammatory arthritis were randomized at primary TKA surgery to receive patellar resurfacing (n = 21; Resurfaced group) or to retain their native patella (n = 17; Non-resurfaced group). Evaluations were performed preoperatively, one, five and 10 years postoperatively by an evaluator who was blinded to group allocation. Self-reported knee-specific stiffness, pain and function, the primary outcomes, were measured by the Western Ontario McMaster Osteoarthritis Index (WOMAC). Revision rate was determined at each evaluation and through hospital record review. RESULTS: 30 (88%) and 23 (72%) of available subjects completed the five and 10-year review respectively. Knee-specific scores continued to improve for both groups over the 10-years, despite diminishing overall health with no significant group differences seen. All revisions occurred within five years of surgery (three Non-resurfaced subjects; one Resurfaced subject) (p = 0.31). Two revisions in the Non-resurfaced group were due to persistent anterior knee pain. CONCLUSIONS: We found no differences in knee-specific results between groups at 5-10 years postoperatively. The Non-resurfaced group had two revisions due to anterior knee pain similar to rates reported in other studies. Knee-specific results provide useful postoperative information and should be used in future studies comparing patellar management strategies. CLINICALTRIALS.GOV IDENTIFIER: NCT01500252.

Prognostic impact of pre-operative albumin on short-term mortality and complications in patients with hip fracture.

Low serum albumin may have prognostic value for morbidity and mortality in patients with hip fracture. The primary aim of the study was to evaluate the independent association between low serum albumin (<35 g/l) at hospital admission and short-term (in-hospital) mortality and post-operative complications of patients with hip fracture. We reviewed a prospective population-based cohort of 583 hip fracture patients who had pre-operative albumin values measured at hospital admission in one of the 3 tertiary hospitals in Northern Alberta, Canada. Patients with a primary diagnosis of hip fracture and 65 years or older were included. The primary outcomes were in-hospital mortality and any pre-specified post-operative complication. Mean serum albumin level was 33.8±4.5 g/l (±S.D.), and overall 55% (n=318) of patients had a low albumin. The in-hospital mortality was 8% (n=46) and rate of any non-fatal post-operative complication rate was 31/100. Mortality was 11% (n=35) among those with low albumin levels and 4% (n=11) for those with normal values (unadjusted odds ratio (OR) 2.86, 95% CI=1.42-5.74). After multivariate adjustment, the association between low serum albumin and mortality remained large and statistically significant (adjusted OR=2.44, 95% confidence interval (CI)=1.17-5.12). Low albumin levels were also significantly associated with post-operative medical complications (adjusted OR=1.96, 95% CI=1.36-2.83). We conclude that routine measurement of serum albumin provides valuable prognostic information for treating this frail population.

The Alberta Hip and Knee Replacement Project: a model for health technology assessment based on comparative effectiveness of clinical pathways.

BACKGROUND: The Alberta Hip and Knee Replacement Project developed a new evidence-based clinical pathway (NCP) for total hip (THR) and knee (TKR) replacement. The aim was to facilitate the delivery of services in a timely and cost-effective manner while achieving the highest quality of care for the patient across the full continuum of care from patient referral to an orthopedic surgeon through surgery, recovery, and rehabilitation. The purpose of this article is to provide an overview of the study design, rationale, and execution of this project as a model for health technology assessment based on comparative effectiveness of alternative clinical pathways. METHODS: A pragmatic randomized controlled trial study design was used to evaluate the NCP compared with the standard of care (SOC) for these procedures. The pragmatic study design was selected as a rigorous approach to produce high quality evidence suitable for informing decisions between relevant interventions in real clinical practice. The NCP was evaluated in three of the nine regional health authorities (RHAs) in Alberta with dedicated central intake clinics offering multidisciplinary care teams, constituting 80 percent of THR and TKR surgeries performed annually in Alberta. Patients were identified in the offices of twenty orthopedic surgeons who routinely performed THR or TKR surgeries. Evaluation outcome measures were based on the six dimensions of the Alberta Quality Matrix for Health (AQMH): acceptability, accessibility, appropriateness, effectiveness, efficiency and safety. Data were collected prospectively through patient self-completed questionnaires at baseline and 3 and 12 months after surgery, ambulatory and inpatient chart reviews, and electronic administrative data. RESULTS: The trial design was successful in establishing similar groups for rigorous evaluation. Of the 4,985 patients invited to participate, 69 percent of patients consented. A total of 3,434 patients were randomized: 1,712 to SOC and 1,722 to the NCP. The baseline characteristics of patients in the two study arms, including demographics, comorbidity as measured by CDS and exposure to pain medications, and health-related quality of life, as measured by Western Ontario and McMaster Universities Osteoarthritis Index and Short Form-36, were similar. CONCLUSIONS: The Alberta Hip and Knee Replacement Project demonstrates the feasibility and advantages of applying a pragmatic randomized controlled trial to ascertain comparative effectiveness. This is a model for health technology assessment that incorporates how clinical pathways can be effectively evaluated.

Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial.

BACKGROUND: The impact of posterior cruciate ligament-substituting and posterior cruciate ligament-retaining devices on the range of motion of the knee following primary total knee arthroplasty is unclear. The primary objective of our study was to compare the range of motion of the knee over the first two postoperative years between subjects who had received the ligament-substituting design and those who had received the ligament-retaining design. Secondarily, pain, function, and health-related quality of life were compared between the two groups. METHODS: We undertook a prospective randomized study of 100 patients with noninflammatory osteoarthritis who were undergoing primary total knee arthroplasty. Patients were randomized at the time of surgery to receive one of the two study prosthesis designs. They were evaluated preoperatively, at the time of hospital discharge, at three months postoperatively, and at up to two years postoperatively by a physical therapist who was blinded to the group allocation. Active knee flexion and extension, measured with a goniometer, were the primary outcome measures. Self-reported pain, function, and health-related quality of life were measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the RAND 36-Item Health Survey (RAND-36). Complications and revision rates were determined through hospital record review and at each patient evaluation. RESULTS: Eighty percent (seventy-eight) of the ninety-eight available patients returned for the final assessment. At two years postoperatively, the mean difference between the groups with regard to knee flexion was 0.03 degrees (95% confidence interval, -5.9 degrees to 6.0 degrees ) and the mean difference in knee extension was 1.0 degrees (95% confidence interval, -0.36 degrees to 2.4 degrees ). Ninety-one (93%) of the ninety-eight available patients completed questionnaires at the time of the final assessment. The two treatment groups had similar pain, function, and quality-of-life scores and complication rates. One subject in the cruciate-retaining group required revision, secondary to a deep joint infection, and one subject in the cruciate-substituting group required manipulation to address poor knee flexion. CONCLUSIONS: Overall, the two treatment groups had a similar range of motion of the knee over the initial two-year postoperative time period. A satisfactory range of motion was achieved by three months postoperatively and was maintained at the final assessment.

Hydroxyapatite-coated tibial implants compared with cemented tibial fixation in primary total knee arthroplasty. A randomized trial of outcomes at five years.

BACKGROUND: Although excellent long-term results have been reported with cemented tibial fixation, cementless fixation as a means to improve the longevity of total knee prostheses continues to be of interest to clinicians. The purpose of this study was to compare outcomes between cementless tibial fixation with hydroxyapatite and cemented tibial fixation in the first five years following primary total knee arthroplasty. METHODS: We performed a prospective, randomized clinical trial that included eighty-one patients with noninflammatory knee arthritis who underwent primary total knee arthroplasty when they were less than seventy years of age. The subjects were randomized at the time of surgery to be treated with either cementless tibial fixation with hydroxyapatite or cemented tibial fixation. Evaluations were performed preoperatively and at six months, one year, and five years postoperatively by a physical therapist who was blinded to group allocation. Self-reported pain and function, the primary outcomes, were measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the RAND 36-Item Health Survey (RAND-36). Complications and revision rates were determined through a review of hospital records and at each patient evaluation. The Knee Society radiographic score was used to evaluate plain radiographs at each assessment. RESULTS: Seventy subjects (86%) completed the five-year assessment. Slightly more pain was reported in the hydroxyapatite group at six months as measured with both the WOMAC and the RAND-36, a difference that disappeared by one year postoperatively. No differences were seen in function, radiographic findings, or complications. No subject required revision of the tibial prosthesis during the study. CONCLUSIONS: At five years postoperatively, there is no difference between cementless tibial fixation with hydroxyapatite and cemented tibial fixation in terms of self-reported pain, function, health-related quality of life, postoperative complications, or radiographic scores.

Total joint arthroplasties: current concepts of patient outcomes after surgery.

Total hip and knee arthroplasties are effective surgical interventions for relieving hip pain and improving physical function caused by arthritis. Although the majority of patients substantially improve, not all report gains or are satisfied after receiving total joint arthroplasty. This article reviews the literature on patient outcomes after total hip and knee arthroplasties for osteoarthritis, and the evidence pertaining to factors that affect these patient-centered outcomes. Mounting evidence suggests that no single patient-related or perioperative factor clearly predicts the amount of pain relief or functional improvement that will occur following total hip or knee arthroplasty.

Reduced morbidity for elderly patients with a hip fracture after implementation of a perioperative evidence-based clinical pathway.

BACKGROUND: Hip fractures, common in the elderly population, result in significant morbidity and mortality. A study was undertaken to determine how an evidence based clinical pathway (CP) for treatment of elderly patients with hip fracture affected morbidity, in-hospital mortality, and health service utilization. METHODS: A pre-post study design using two population based inception cohorts of hip fracture patients aged > or =65 years was used. The control group (n = 678) was enrolled between July 1996 and September 1997 before implementation of the pathway and the CP group (n = 663) was enrolled between July 1999 and September 2000 following pathway implementation. Chart reviews were completed during study time frames to determine complications, mortality, and health service utilization. RESULTS: Only nine patients (1%) in the CP group experienced postoperative congestive heart failure compared with 37 (5%) control patients (p<0.001). Postoperative cardiac arrythmias were significantly lower in the CP group than in the control group (8 (1%) v 36 (5%); p<0.001). Postoperative delirium occurred in 22% of the CP group and 51% of the control group (p<0.001). There was no difference in risk adjusted in-hospital mortality between the two groups. Overall length of stay (LOS) and costs were unchanged between the groups; however, hospital LOS increased while rehabilitation LOS decreased in the CP group. CONCLUSION: Implementation of an evidence based clinical pathway reduced postoperative morbidity and did not affect in-hospital mortality or overall costs of inpatient care. The effect of changing trends in medical care cannot be ruled out, but the reduction in complications in several clinical areas lends support to the positive impact of the clinical pathway. Perioperative CP is one successful management approach for this fragile patient population as patient morbidity was reduced without negatively affecting resource utilization.

Lack of association between mortality and timing of surgical fixation in elderly patients with hip fracture: results of a retrospective population-based cohort study.

BACKGROUND: Conventional wisdom suggests high-quality care for most patients with hip fractures is surgical fixation within 24 hours to reduce mortality and complications, although there is little evidence to support this standard. OBJECTIVES: We sought to determine the relationship between timing of hip fracture surgery and early mortality. DESIGN AND SUBJECTS: This was a retrospective population-based cohort study of 3981 patients with hip fractures>60 years of age that were admitted to hospitals in one Canadian health region from 1994-2000. METHODS: We collected sociodemographic, prefracture comorbidity, and postoperative complication data. Timing of surgery was classified as within 24 hours ("early surgery," the referent group for all analyses), 24-48 hours, and beyond 48 hours. Main outcome was in-hospital mortality. We used multivariable logistic regression methods, including adjustments with propensity scores and a validated hip fracture-specific mortality index, to determine the independent association between early versus later surgery and mortality. RESULTS: Median age of patients was 82 years, 71% were women, and 26% had >4 prefracture comorbidities. Unadjusted in-hospital mortality was 6%; it was 5% for those who had surgery within 24 hours or from 24 to 48 hours, 10% for surgery beyond 48 hours, and 21% for patients that did not have surgery. Compared with those who had surgery within 24 hours, there was no independent association between timing of surgery and in-hospital mortality (24-48 hours, adjusted odds ratio 0.89, 95% confidence interval 0.62-1.30, P=0.55; beyond 48 hours 1.30, 95% confidence interval 0.86-2.00], P=0.21). CONCLUSIONS: The timing of surgical fixation of hip fracture was not associated with early mortality in carefully adjusted analyses, and the use of "surgery within 24 hours" as a measure of high quality care may be inappropriate.

Total joint arthroplasties: current concepts of patient outcomes after surgery.

Total hip and knee arthroplasties are effective surgical interventions for relieving pain and improving physical function caused by arthritis. Although the majority of patients substantially improve, not all reports gains or are satisfied after receiving a total joint arthroplasty. This article reviews the literature on patient outcomes after total hip and knee arthroplasties for osteoarthritis and the evidence pertaining to factors that affect these patient-centered outcomes. Mounting evidence suggests that no one patient-related or peri-operative factor clearly predicts the amount of pain relief or functional improvement that will occur following total hip or knee arthroplasty.