The optimal alignment technique for total knee replacement (TKR) remains controversial. We previously reported six-month and two-year results of a randomized controlled trial comparing kinematically (KA) versus mechanically (MA) aligned TKR. In the present study, we report 12-year results from this trial. The original cohort included 88 TKRs (44 KA using Shape Match patient-specific guides and 44 MA using conventional instrumentation), performed from 2008 to 2009. After IRB approval, the health record of the original 88 patients were queried. Revisions, re-operations, and complications were recorded. The non-deceased patients were contacted via phone. Reoperation and complications were documented via the patient's history. Further, a battery of patient-reported outcome measures (including patient satisfaction, WOMAC, Oxford, KOOS Jr, Forgotten Joint Score, and M-SANE) were obtained.Abstract
Introduction
Methods
The Syn-VAR RCT is the first of its kind comparing hamstrings autograft v synthetic neoligament for MPFL reconstruction. Our aim is to evaluate short and long term patient related outcomes measures (PROMs) following synthetic / autologous MPFL reconstruction in a heterogenous cohort of patients with recurrent patellar instability. 20 patients meeting inclusion criteria were recruited and randomised. Standardised surgery was performed by a single surgeon in Altnagelvin Hospital with data collected over 3 years from 2016. Kujala score was the primary outcome measure with data captured preoperatively and 12 weeks/2 years postoperatively. Secondary outcomes included four other validated scores and complications including Norwich Patellar Instability, Lysholm, IKDC and BanffAbstract
Introduction
Method
The effectiveness of single intra-articular injections of polyacrylamide hydrogel (iPAAG) and hyaluronic acid (HA) was compared in subgroups of participants from an RCT based on baseline age, BMI or Kellgren-Lawrence (KL) grade. 239 participants were randomised to 6 mL iPAAG (Arthrosamid; n=119) or 6 mL HA (Synvisc-One; n=120). Participants continued analgesics (except 48 hours prior to visits) and non-pharmacological therapy. Topical therapies and intra-articular corticosteroids were not allowed. Pre-specified subgroup analyses (age: <70 years, ≥70 years; BMI: normal, overweight, obese; KL grade: 2, 3, 4, 2–3) of change from baseline in WOMAC pain subscale at 52 weeks were based on the least squares means for the treatment-by-week interaction effect using a mixed model for repeated measurement with a restricted maximum likelihood-based approach.Abstract
Introduction
Methodology
Adverse reactions to pain medication and pain can delay discharge after outpatient knee arthroplasty (TKA). Pharmacogenomics is an emerging tool that might help reduce adverse events by tailoring medication use based on known genetic variations in the CYP genes determining drug metabolism. This study was undertaken to evaluate whether pre-operative pharmacogenomic testing could optimize peri-operative pain management in patients undergoing total knee arthroplasty (TKA). This prospective, randomized study was performed in adults undergoing primary TKA. Patients in the experimental group underwent pre-operative pharmacogenomic evaluation and medication adjustments. Medications were not optimized for control patients. The Overall Benefit of Analgesic Score (OBAS) at 24 hours post-op was the primary outcome. Postoperative pain scores (VAS scale), total opioid use, time in recovery, and time to discharge were also compared.Abstract
Introduction
Methods
Challenges in surgical training have led to the exploration of technologies such as augmented reality (AR), which present novel approaches to teaching orthopaedic procedures to medical students. The aim of this double-blinded randomised-controlled trial was to compare the validity and training effect of AR to traditional teaching on medical students’ understanding of total knee arthroplasty (TKA). Twenty medical students from 7 UK universities were randomised equally to either intervention or control groups. The control received a consultant-led teaching session and the intervention received training via Microsoft HoloLens, where surgeons were able to project virtual information over physical objects. Participants completed written knowledge and practical exams which were assessed by 2 orthopaedic consultants. Training superiority was established via 4 quantitative outcome measures: OSATS scores, a checklist of TKA-specific steps, procedural time, and written exam scores. Qualitative feedback was evaluated using a 5-point Likert scale.Abstract
Introduction
Methodology
There is a need to develop approaches to reduce chronic pain after total knee replacement. There is an established link between disturbed sleep and pain. We tested the feasibility of a trial evaluating the clinical and cost-effectiveness of a pre-operative sleep assessment and complex intervention package for improving long-term pain after TKR. REST was a feasibility multi-centre randomised controlled trial with embedded qualitative study and health economics. Participants completed baseline measures and were randomised to usual care or the intervention, a tailored sleep assessment and behavioural intervention package delivered by an extended scope practitioner three months pre-operatively with a follow-up call up at four-weeks. Patient reported outcomes were assessed at baseline, one-week pre-surgery, and 3-months post-surgery.Abstract
Introduction
Methodology
The Oxford Unicompartmental Knee Replacement's (OUKR's) fully-congruent design minimises polyethylene wear. Consequently, wear is a rare failure mechanism. Phase-3 OUKR linear wear at 5 years was higher than previous OUKR phases, but very low compared to fixed-bearing UKRs. This study aimed to measure OUKR bearing wear at 10 years and investigate factors that may affect wear. Bearing thickness for 39 OUKRs from a randomised study was calculated using radiostereometric analysis at regular intervals up to 10 years. Data for 39 and 29 OUKRs was available at 5 and 10 years, respectively. As creep occurs early, wear rate was calculated using linear regression between 6 months and 10 years. Relationships between wear and patient factors, fixation method, Oxford Knee Score (OKS), bearing position, and component position were analysed.Abstract
Introduction
Methodology
This multi-centre randomised controlled trial evaluated the clinical and cost effectiveness of liposomal bupivacaine for pain and recovery following knee replacement. 533patients undergoing primary knee replacement were randomised to receive either liposomal bupivacaine (266mg) plus bupivacaine hydrochloride (100mg) or control (bupivacaine hydrochloride 100mg), administered at the surgical site. The co-primary outcomes were pain visual analogue score (VAS) area under the curve (AUC) 6 to 72hours and the Quality of Recovery 40 (QoR-40) score at 72hours.Abstract
Introduction
Methodology
Frailty is associated with poorer outcomes after joint replacement. Targeting frailty pre-operatively via protein supplementation and exercise has the potential to improve outcomes after joint replacement. Before conducting a randomised controlled trial (RCT), a feasibility study is necessary to address key uncertainties and explore how to optimise trial design. Joint PREP is a feasibility study for a multicentre, two-arm, parallel group, pragmatic, RCT to evaluate the clinical and cost-effectiveness of prehabilitation for frail patients undergoing total hip or knee replacement. Sixty people who are ≥65 years of age, frail and scheduled to undergo total hip or knee replacement at 2–3 NHS hospitals will be recruited and randomly allocated on a 1:1 ratio to the intervention or usual care group. The intervention group will be given a daily protein supplement and will be asked to follow a home-based, tailored daily exercise programme for 12 weeks before their operation, supported by fortnightly telephone calls from a physiotherapist. Embedded qualitative research with patients will explore their experiences of participating, reasons for non-participation and/or reasons for withdrawal or treatment discontinuation.Abstract
Introduction
Methodology
This study aims to compare the clinical and functional outcomes and donor site morbidity of anterior cruciate ligament reconstruction with hamstring tendon autograft and peroneus longus tendon autograft in patients with complete anterior cruciate ligament rupture. Patients who underwent ACL reconstruction from February 2018 to July 2019 were randomly allocated into two groups (hamstring and peroneus longus). Functional scores (IKDC and Lysholm scores) and pain intensity by visual analogue score were recorded preoperatively, 3, 6months, 1, and 2 years postoperatively. Donor site morbidities were assessed with thigh circumference measurements in hamstring group and ankle scoring with the American foot and ankle score in peroneus longus group.Abstract
Purpose
Methods
Cryocompression therapy after knee surgery is widely utilised for post-operative rehabilitation. Skin temperature should be reduced to 10–15°C to maximise the therapeutic benefits while avoiding risks of adverse events. Some cryocompression devices offer control over the temperature of the ice-water circulated through a cuff. The degree to which this corresponds to the achieved skin temperature during a treatment is unknown. 30 healthy participants volunteered for this prospective randomised crossover trial involving the use of a cryocompression device. Each underwent a 30-minute test in all of five conditions: A, B, C, D and Control. Conditions corresponded to device temperature settings of 6, 8, 10, 12°C and no ice-water circulation, respectively. Skin temperature was measured prior to the cuff being applied, then every 5 minutes during a test.Abstract
Introduction
Methods
Cementless fixation of Oxford Unicompartmental Knee Replacements (UKRs) is an alternative to cemented fixation, however, it is unknown whether cementless fixation is as good long-term. This study aimed to compare primary and long-term fixation of cemented and cementless Oxford UKRs using radiostereometric analysis (RSA). Twenty-nine patients were randomised to receive cemented or cementless Oxford UKRs and followed for ten years. Differences in primary fixation and long-term fixation of the tibial components (inferred from 0/3/6-month and 6-month/1-year/2-year/5-year/10-year migration, respectively) were analysed using RSA and radiolucencies were assessed on radiographs. Migration rates were determined by linear regression and clinical outcomes measured using the Oxford Knee Score (OKS).Abstract
Introduction
Methodology
The postoperative inflammatory response may be implicated in the aetiology of patient dissatisfaction following Total Knee Arthroplasty. Robotic-arm assisted TKA has been associated with reduced bone and soft tissue trauma. The objective of this Randomised Controlled Trial was to compare the inflammatory response in conventional Jig-based versus robotic arm-assisted TKA and examine the relationship with patient reported outcome measures and functional outcomes. 30 patients with knee osteoarthritis were randomised to either conventional or robotic-arm assisted TKA. Blood samples were collected for up to 28 days post-operatively and intraarticular drain samples at 6 and 24 hours, to ascertain the systemic and local inflammatory responses. The Spearman's correlation was utilised to evaluate the relationship with PROMs and functional outcomes.Abstract
Introduction
Methodology
The purpose of this study is to evaluate the early perioperative outcomes after primary knee arthroplasty with the use of a smartphone-based exercise and educational platform compared to a standard of care control group. A multicenter prospective randomized control trial was conducted evaluating the use of the mymobility smartphone-based care platform for primary total knee arthroplasty (TKA) and unicondylar knee arthroplasty (UKA). Patients in the control group (224 patients) received the respective institution's standard of care typically with formal physical therapy. Those randomized to mymobility treatment group (192 patients) were provided an Apple Watch and mymobility smartphone application. The treatment group was not initially prescribed physical therapy, but could if their surgeon determined it necessary. Early outcomes assessed included 90-day knee range of motion, KOOS Jr scores, 30-day single leg stance (SLS) time, Time up and Go (TUG) time and need for manipulation under anesthesia (MUA). There was no significant difference in age, BMI or gender between groups.Background
Methods
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
The purpose of this multi-center, randomized clinical trial was to compare static and articulating spacers in the treatment of PJI complicating total knee arthroplasty TKA. 68 Patients treated with two-stage exchange arthroplasty were randomized to either a static (32 patients) or an articulating (36 patients) spacer. A power analysis determined that 28 patients per group were necessary to detect a 13º difference in range of motion between groups. Six patients were excluded after randomization, six died, and seven were lost to follow-up prior to two years.Background
Methods
Optimal perioperative fluid management has not been established in patients undergoing orthopaedic surgical procedures. Our purpose was to investigate the effects of perioperative fluid management on patients experiencing TKA. One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA were prospectively randomized into traditional (TFG) vs. oral (OFG) perioperative fluid management groups. The TFG had a predetermined (4L) amount of intravenous fluids (IVF) administered in the perioperative period. The OFG began drinking a minimum of three, 20-ounces servings of clear fluids daily for three days prior to surgery. This cohort also drank 10-ounces of clear fluids 4 hours prior to surgery. Perioperative IVF were discontinued when the patient began oral intake or when the total amount of IVF reached 500mL. Outcome measures included: body-weight (BW) fluctuations, knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, KOOS JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events.Background
Methods
Patient expectations of total knee arthroplasty (TKA) can be managed through education. E-learning is the application of information technology to education. Providing information to patients at the place and time of their choosing, e-learning has the potential to broaden the reach of existing services for patients. This study evaluated whether an e-learning tool could affect whether patients felt their expectations were met and whether they were satisfied with surgery one year following primary TKA. We recruited consecutive patients with osteoarthritis and randomized them to either standard patient education (n=207), or to our standard patient education plus a new e-learning tool (n=209). Preoperative measures were completed following the patients’ Pre-Admission clinic (PAC) visit and prior to accessing the e-learning tool. Postoperative patient reported outcome measures (PROMs) were completed at six weeks, three months and one year after TKA. We used the Postoperative Expectation Questionnaire to measure the degree to which patient expectations had been met and the Patient Acceptable Symptom State (PASS) question to measure patient satisfaction at one year postoperative. We collected several PROMs for descriptive purposes including: new Knee Society Knee Scoring System (KSS); (Pre-Op and Post-Op versions), Knee injury and Osteoarthritis Outcome Score (KOOS), the Medical Outcomes Study 12-Item Short Form Health Survey, version 2 (SF-12), Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), University of California at Los Angeles (UCLA) Activity Score, and the Social Role Participation Questionnaire (SRPQ).Purpose
Method
The objectives of this study were to compare the systemic inflammatory reaction, localised thermal response and macroscopic soft tissue injury outcomes in conventional jig-based total knee arthroplasty (conventional TKA) versus robotic total knee arthroplasty (robotic TKA). This prospective randomised controlled trial included 30 patients with symptomatic knee osteoarthritis undergoing conventional TKA versus robotic TKA. Predefined serum markers of inflammation and localised knee temperature were collected preoperatively and postoperatively at 6 hours, day 1, day 2, day 7, and day 28 following TKA. Blinded observers used the Macroscopic Soft Tissue Injury (MASTI) classification system to grade intraoperative periarticular soft tissue injury and bone trauma. Plain radiographs were used to assess the accuracy of achieving the planned limb alignment and implant positioning in both treatment groups.Introduction
Methods
Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA that is associated with greater blood loss. The purpose of this multi-center randomized trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA. 233 Septic and aseptic revision TKA from six-centers were randomized to either receive 1g pre-incision intravenous (IV) TXA, 1g pre- and post-incision IV TXA, 1g pre-incision IV and 1g intra-operative topical TXA, or three doses of 1950mg oral TXA given 2 hours pre-operatively, 6 hours post-operatively, and the morning of postoperative day 1. Randomization was performed based on type of revision to ensure equivalent distribution among groups. The primary outcome was reduction in hemoglobin. Power analysis determined 40 patients per group were necessary to identify a 1g/dL difference with an alpha of 0.05 and beta of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence.Introduction
Methods