A pragmatic, multicentre, parallel-group, randomised controlled trial to determine whether the intervention is superior to comparator 20 NHS HospitalsAbstract
Design
Setting
Topical diclofenac has proven efficacy and safety in the management of osteoarthritic pain. Its therapeutic efficacy is dependent on its ability to deliver pharmacodynamically active concentrations to the underlying tissues in the affected joint. However, the disposition of topical diclofenac is not fully characterized, and no studies have been performed using diclofenac diethylamine 2.32% gel. This study investigated the penetration of topical diclofenac into knee synovial tissue and fluid and evaluated relative exposure in the knee versus plasma. In this phase 1, double-blind, placebo-controlled steady-state multicenter pharmacokinetic study, patients scheduled for arthroplasty to treat knee OA were randomly assigned 2:1 to 4 g diclofenac/placebo gel, applied to the affected knee every 12 hours for 7 days pre-surgery. Diclofenac concentrations were measured in synovial tissue, fluid, and plasma ≥12 hours after last application. Adverse events (AEs) were evaluated. Diclofenac concentrations were assayed by validated high-performance liquid chromatography and tandem mass spectrometry.Introduction
Methods
Recent advancements in optical navigated TKA have shown improved overall limb alignment, implant placement and reduced outliers compared to conventional TKA. This study represents the first RCT comparing EM navigation and conventional TKA. 3D alignment was analysed from CT scans. Clinical scores (Oxford Knee Score (OKS) and American Knee Society Score (AKSS)) were recorded at pre-op, 3 and 12 months post-op. Data presented includes 180 patients (n=90 per group) at 3 months and 140 (n=70 per group) at 12 months. The groups had similar mean mechanical axis alignments (EM 0.31° valgus; conventional 0.15° valgus). Mechanical axis alignment however was improved in the EM group with 92% within +/−3° of neutral compared to 84% of the conventional group (p=0.90). The EM group showed improved coronal and sagittal femoral alignment and improved coronal, sagittal and rotational tibial alignment, which was significant for sagittal femoral alignment (p=0.04). The OKS and AKSS scores were significantly better for the EM group at 3 months post-op (OKS p=0.02, AKSS p=0.04), but there was no difference between groups at 12 months. The mean pre-op range of motion (ROM) for both groups was 105°. This decreased at 3 months to 102° in the EM group and 99° in the conventional group, but there was a significant improvement by 12 months: EM=113° (p=0.012) and conventional=112° (p=0.026). ROM was statistically similar between groups at all assessment phases. Knee alignment was better restored following EM navigated TKA relative to conventional TKA, but the difference was not significant. The EM group showed greater clinical improvements at early follow-up; however this difference was not sustained at 12 months. ROM was seen to decrease at 3 months but then significantly improve by 12 month post-op. Proving cost-effectiveness for navigation systems in TKA remains a challenge.
Unidirectional mobile bearing knees (RP) were developed to optimise the tibio-femoral articulation in an effort to enhance function and reduce polyethylene wear. The self aligning bearing should also benefit the patello-femoral joint further improving outcome. This study was designed to assess whether these potential benefits are realised in the clinical setting. A total of 352 patients undergoing a PS PFC Sigma TKR were randomly allocated to receive either a Mobile Bearing (176 knees) or a Fixed Bearing (176 knees) tibial tray. Within each group a further randomisation for patella resurfacing versus retention was included. All knees were scored using standard tools (Oxford, AKSS, Patella Score) by independent nurse specialists. At 5 year review there had been 38 deaths (19 in each group), 5 revisions (4 fixed, 1 RP), 7 late patella resurfacings (4 fixed, 3 RP) and a small number of other patients had withdrawn, leaving 142 fixed bearing knees and 144 mobile bearing knees for evaluation.Introduction
Methods
We report a large study of 331 patients at two years post operation who were prospectively randomised to receive either a rotating platform or a fixed bearing knee replacement of an otherwise identical design. The mobile bearing total knee replacement was developed as there are theoretical benefits in that it may allow a better range of motion, better patella tracking and lower wear rates. This study was designed to see if these potential advantages are borne out in practice when using a cruciate retaining design.Summary
Introduction
Previous studies comparing cruciate retaining (CR) and cruciate sacrificing - posterior stabilised (PS) TKRs have failed to demonstrate a difference in outcomes based on numbers of patients recruited. This large study compares clinical outcomes in groups having PS and CR TKR and reports the results at 1 and 2 years post-operatively. A total of 683 patients undergoing TKR were consecutively enrolled in a prospective multi-centre study with 2 arms. In the first arm patients receiving a PS component were randomised to receive either a mobile bearing (176 patients) or fixed bearing (176 patients) implant. In the second arm, patients receiving a CR component were randomised to receive either a mobile bearing (161 patients) or fixed bearing (170 patients) implant. All patients were assessed preoperatively and at one and two years postoperatively using standard tools (Oxford, AKSS, Patellar Score) by independent nurse specialists. The data from the 2 arms of the trial were then analysed to compare differences between PS and CR implants.Introduction
Methods
