Two knees or not two knees? Patient costs and outcomes following bilateral and unilateral total knee joint replacement surgery for OA

Aims: This study aims to address medical and non-medical direct costs and health outcomes of bilateral and unilateral total knee replacement from the patients' perspective during the first year post-surgery. Methods: Osteoarthritis patients undergoing primary unilateral total knee or bilateral total knee replacement (TKR) surgery at three Sydney hospitals were eligible. Patients completed questionnaires pre-operatively to record expenses during the previous three months and health status immediately prior to surgery. Patients then maintained detailed prospective cost diaries and completed SF-36 and WOMAC Index each three months for the first post-operative year. Results: Pre-operatively, no significant differences in health status were found between patients undergoing unilateral TKR and bilateral TKR. Both unilateral and bilateral TKR patients showed improvements in pain, stiffness and function from pre-surgery to 12 months post-surgery. Patients who had bilateral TKR spent an average of 12.3 days in acute hospital and patients who had unilateral TKR 13.6 days. Totally uncemented prostheses were used in 6% of unilateral replacements and 48% of bilateral replacements. In hospital, patients who had bilateral TKR experienced significantly more complications, mainly thromboembolic, than patients who had unilateral TKR. Regression analysis showed that for every one point increase in the pre-operative SF-36 physical score (i.e. improving physical status) out-of-pocket costs decreased by 94%. Out-of-pocket costs for female patients were 3.3 times greater than for males. Conclusion: Patients undergoing bilateral TKR and unilateral TKR had a similar length of stay in hospital and similar out-of-pocket expenditures. Bilateral replacement patients reported better physical function and general health with fewer health care visits one year post procedure. Patients requiring bilateral TKR have some additional information to aid their decision making. While their risk of peri-operative complications is higher, they have an excellent chance of good health outcomes at 12 months and are not going to be doubly 'out-of-pocket' for the experience. (C) 2004 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

A Cochrane review (update 2004): Hylan G-F 20 vs placebo for knee OA

Aim of study: As part of a Cochrane review of viscosupplementation in knee OA, randomised controlled trials (RCT) were reviewed to evaluate evidence for the efficacy of viscosupplementation with Hylan G-F 20 compared to placebo. Methods: Electronic searches were conducted of MEDLINE, EMBASE, Premedline, Current Contents, and CENTRAL. Human, RCT involving Hylan G-F 20 compared to placebo, published prior to 1Q2004, were included. Trials were selected and data extracted by two independent reviewers. Methodological quality was assessed with the Jadad criteria by two reviewers. Data on the OARSI and OMERACT core set clinical outcome measures were extracted where possible. Weighted mean difference (WMD), based on post-test scores, and 95% confidence intervals (CI) were calculated for continuous outcome measures and relative risk (RR) for dichotomous outcome measures. Results: Seven RCT met the inclusion criteria. Median methodological quality was 4 (range 1–5). A further two studies were only reported in abstract form (Jadad score Z 1) and contained insufficient extractable data for inclusion in the analysis. Nine RCT, which compared Hylan G-F 20 to other interventions such as intra-articular corticosteroid, physiotherapy, NSAID, appropriate care, intra-articular gaseous oxygen and other hyaluronan, are not reported here. Twenty-three studies failed to meet inclusion criteria and were excluded. Hylan G-F 20 was more efficacious than placebo at 1–4 weeks post-injection for pain on weight-bearing WMD (random effects [RE]) 13 mm on a 0–100 mm VAS (P Z 0.002) based on 6 RCT. This difference was even greater at 5–13 weeks post-injection, 22 m (RE) (P Z 0.001) based on 5 RCT, and at 14–6 weeks postinjection, 21 m (RE) (P Z 0.006) based on 4 RCT. Hylan G-F 20 was more efficacious than placebo at 1–4 weeks post-injection for pain at night, WMD 7 mm on a 0–100 mm VAS (P Z 0.003) based on 5 RCT. This difference was even greater at 5–13 weeks post-injection, 11 mm (P Z 0.008) based on 4 RCT, and at 14–26 weeks post-injection, 17 mm (P ! 0.00001) based on 3 RCT. There was no significant difference (WMD 8 mm) between Hylan G-F 20 C oral placebo and arthrocentesis C oral placebo at 5–13 weeks post-injection for WOMAC Pain, but Hylan G-F 20 C oral placebo was more efficacious than arthrocentesis C oral placebo for WOMAC Function, WMD 9 mm on a 0–100 mm VAS (P Z 0.01) (Dickson, 2001). Hylan G-F 20 was more effective than placebo at 1–4 weeks postinjection for the variable designed treatment efficacy, WMD 22 mm on a 0–100 mm VAS (P ! 0.00001) based on improvement in 4 RCT. This difference was even greater at 5–13 weeks post injection, 35 mm (P ! 0.00001). Conclusions: Evidence from this updated Cochrane review supports the superior efficacy of Hylan G-F 20 compared to placebo on weight-bearing pain, night pain, function and treatment efficacy in the treatment of knee OA.

Predictors of osteoarthritis(OA) improvement in patients treated with Hylan G-F for knee OA.

Aim of study: Different criteria for treatment response were explored to identify predictors of OA improvement. Analyses were based on data from a previously reported 1-year randomized controlled trial of appropriate care with or without hylan G-F 20 in patients with knee OA. Methods: Five definitions of ‘‘patient responder’’ from baseline to month 12 were examined: at least 20% reduction in WOMAC pain score; at least 20% reduction in WOMAC pain score and at least 20% reduction in either the WOMAC stiffness or function score; OARSI responder criteria (Propositions A and B) for intra-articular drugs; and OMERACT-OARSI responder criteria (Proposition D). As an a posteriori analysis, multivariable logistic regression models for each definition of patient responder were developed using a forward selection method. The following variables were defined prior to modeling and considered in the model along with two-way interactions: age (O65 years), BMI, gender, X-ray grade (0, I, II vs III, IV), co-morbidity (1 or 2 conditions vs 3 or more), duration of OA in study knee (years), previous surgery of study knee, hylan G-F 20 injection technique, WOMAC pain, stiffness and function, and treatment group. Results: Hylan G-F 20 was a predictor of improvement for all patient responder definitions P ! 0.001; odds of improvement were 2.7 or higher for patients in the hylan G-F 20 group compared to appropriate care without hylan G-F 20. For three of the five patient responder definitions, X-ray grade was a predictor of improvement (P ! 0.10; lower X-ray grade increased the odds of improvement). For four of the five patient responder definitions, duration of OA was a predictor of improvement (P ! 0.10; shorter duration of OA increased the odds of improvement). Conclusion: Analyses showed that appropriate care with hylan G-F 20 is the dominant predictor of patient improvement. While high grade structural damage does not preclude a response, patients who are targeted early in the disease process when less structural damage has occurred, may have a greater chance of improvement.