To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS). A cost-utility analysis was undertaken alongside KReBS, a pragmatic, two-arm, open label, parallel-group, randomized controlled trial, in terms of the cost per quality-adjusted life year (QALY). Overall, 2,330 participants scheduled for total knee arthroplasty (TKA) were randomized to either a two-layer compression bandage or a standard wool and crepe bandage. Costs were estimated over a 12-month period from the UK NHS perspective, and health outcomes were reported as QALYs based on participants’ EuroQol five-dimesion five-level questionnaire responses. Multiple imputation was used to deal with missing data and sensitivity analyses included a complete case analysis and testing of costing assumptions, with a secondary analysis exploring the inclusion of productivity losses.Aims
Methods
A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits.Aims
Methods
The aim of this study was to estimate the incremental use of resources, costs, and quality of life outcomes associated with surgical reconstruction compared to rehabilitation for long-standing anterior cruciate ligament (ACL) injury in the NHS, and to estimate its cost-effectiveness. A total of 316 patients were recruited and randomly assigned to either surgical reconstruction or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment). Healthcare resource use and health-related quality of life data (EuroQol five-dimension five-level health questionnaire) were collected in the trial at six, 12, and 18 months using self-reported questionnaires and medical records. Using intention-to-treat analysis, differences in costs, and quality-adjusted life years (QALYs) between treatment arms were estimated adjusting for baseline differences and following multiple imputation of missing data. The incremental cost-effectiveness ratio (ICER) was estimated as the difference in costs divided by the difference in QALYs between reconstruction and rehabilitation.Aims
Methods
Loosening of components after total knee arthroplasty (TKA) can be associated with the development of radiolucent lines (RLLs). The aim of this study was to assess the rate of formation of RLLs in the cemented original design of the ATTUNE TKA and their relationship to loosening. A systematic search was undertaken using the Cochrane methodology in three online databases: MEDLINE, Embase, and CINAHL. Studies were screened against predetermined criteria, and data were extracted. Available National Joint Registries in the Network of Orthopaedic Registries of Europe were also screened. A random effects model meta-analysis was undertaken.Aims
Methods
The primary objective of this study was to compare the five-year tibial component migration and wear between highly crosslinked polyethylene (HXLPE) inserts and conventional polyethylene (PE) inserts of the uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary objectives included clinical outcomes and patient-reported outcome measures (PROMs). A double-blinded, randomized study was conducted including 96 TKAs. Tibial component migration and insert wear were measured with radiostereometric analysis (RSA) at three, six, 12, 24, and 60 months postoperatively. PROMS were collected preoperatively and at all follow-up timepoints.Aims
Methods
The aim of this study was to compare the clinical outcomes of robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA) with conventional mechanically aligned total knee arthroplasty (TKA) during the first six weeks and at one year postoperatively. A per protocol analysis of 76 patients, 43 of whom underwent TKA and 34 of whom underwent bi-UKA, was performed from a prospective, single-centre, randomized controlled trial. Diaries kept by the patients recorded pain, function, and the use of analgesics daily throughout the first week and weekly between the second and sixth weeks. Patient-reported outcome measures (PROMs) were compared preoperatively, and at three months and one year postoperatively. Data were also compared longitudinally and a subgroup analysis was conducted, stratified by preoperative PROM status.Aims
Methods
For many designs of total knee arthroplasty (TKA) it remains unclear whether cemented or uncemented fixation provides optimal long-term survival. The main limitation in most studies is a retrospective or non-comparative study design. The same is true for comparative trials looking only at the survival rate as extensive sample sizes are needed to detect true differences in fixation and durability. Studies using radiostereometric analysis (RSA) techniques have shown to be highly predictive in detecting late occurring aseptic loosening at an early stage. To investigate the difference in predicted long-term survival between cemented, uncemented, and hybrid fixation of TKA, we performed a randomized controlled trial using RSA. A total of 105 patients were randomized into three groups (cemented, uncemented, and hybrid fixation of the ACS Mobile Bearing (ACS MB) knee system, implantcast). RSA examinations were performed on the first day after surgery and at scheduled follow-up visits at three months, six months, one year, and two years postoperatively. Patient-reported outcome measures (PROMs) were obtained preoperatively and after two years follow-up. Patients and follow-up investigators were blinded for the result of randomization.Aims
Methods
The aim of this study was to identify the most effective regimen
of multiple doses of oral tranexamic acid (TXA) in achieving maximum
reduction of blood loss in total knee arthroplasty (TKA). In this randomized controlled trial, 200 patients were randomized
to receive a single dose of 2.0 g of TXA orally two hours preoperatively
(group A), a single dose of TXA followed by 1.0 g orally three hours
postoperatively (group B), a single dose of TXA followed by 1.0 g
three and nine hours postoperatively (group C), or a single dose
of TXA followed by 1.0 g orally three, nine, and 15 hours postoperatively
(group D). All patients followed a routine enhanced-recovery protocol.
The primary outcome measure was the total blood loss. Secondary
outcome measures were hidden blood loss (HBL), reduction in the
level of haemoglobin, the rate of transfusion and adverse events.Aims
Patients and Methods
The aims of this study were to compare the efficacy and safety
of intra-articular and intravenous (IV) tranexamic acid (TXA) in
controlling perioperative blood loss in total knee arthroplasty
(TKA) using a randomized, double-blinded equivalence trial. A total of 182 patients aged between 45 and 75 years undergoing
unilateral TKA at a tertiary centre were randomized to receive TXA,
either 1.5 g intra-articularly after closure of the wound (n = 91)
or two doses of 10 mg/kg IV (n = 91). The primary outcome measure
was the reduction in the level of haemoglobin (Hb) in the blood
on the fifth postoperative day. Secondary outcome measures were
the total, visible, and hidden blood losses (TBL, VBL, HBL). We
assumed equivalence of the primary outcome in both routes with a
margin of ± 0.35gm/dl. Block randomization using computer-generated
random numbers was used. The patients and the assessor of outcome were
blinded.Aims
Patients and Methods
Meniscal allograft transplantation is undertaken to improve pain
and function in patients with a symptomatic meniscal deficient knee
compartment. While case series have shown improvements in patient
reported outcome measures (PROMs), its efficacy has not been rigorously
evaluated. This study aimed to compare PROMs in patients having
meniscal transplantation with those having personalized physiotherapy
at 12 months. A single-centre assessor-blinded, comprehensive cohort study,
incorporating a pilot randomized controlled trial (RCT) was performed
on patients with a symptomatic compartment of the knee in which
a (sub)total meniscectomy had previously been performed. They were
randomized to be treated either with a meniscal allograft transplantation
or personalized physiotherapy, and stratified for malalignment of
the limb. They entered the preference groups if they were not willing
to be randomized. The Knee injury and Osteoarthritis Outcome Score (KOOS),
International Knee Documentation Committee (IKDC) score and Lysholm
score and complications were collected at baseline and at four,
eight and 12 months following the interventions.Aims
Patients and Methods
