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Abstract. Design. A pragmatic, multicentre, parallel-group, randomised controlled trial to determine whether the intervention is superior to comparator. Setting. 20 NHS Hospitals. Population. NHS patients <60 years with moderate-severe symptomatic knee OA localised to the medial compartment in whom surgical intervention is indicated. Intervention. Surgery with medial opening wedge high tibial osteotomy (HTO) followed by standard postoperative rehabilitation based on local pathways. Comparator. Tailored non-surgical intervention delivered within an NHS physiotherapy department delivered over 6-contact sessions within a period of 4 months. Outcomes. Primary outcome - 24-month Knee Injury and Osteoarthritis Outcome Score (KOOS); Secondary outcomes - OKS, FJS-12, EQ-5D-3L, Pittsburgh Sleep Problem Scale, Return to Work, secondary surgical interventions and complications at 12 and 24 months following randomisation. Health economic evaluation - 24-month within trial analysis, and a decision analytic simulation model to account for the impacts of future knee replacements (and associated revisions), and their timing relative to retirement and employment potential. Process evaluation – to explore trial eligibility, recruitment and retention rates, acceptability of intervention implementation and patient experience of taking part/contextual factors that influence this. Follow up. 12 months and 24 months post-randomisation. Sample size. 224 patients; (90% power, 2-sided p=0.05, equivalent to a sample size of 97 per group). Allowing for 15% loss to follow up, 112 patients will be recruited to each arm of the trial. Project timelines. Start date 1 August 2022, total project duration 60 months including a 9-month, 5-site internal pilot, with a recruitment rate of 0.7 patients/site/month


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 19 - 19
1 Oct 2020
Murray DW
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Background. There are advantages and disadvantages of Unicompartmental (UKR) and Total Knee Replacement, with UKR having better functional outcomes with fewer complications but a higher revision rate. The relative merits depend on patient characteristics. The aim was to compare UKR and TKR risk-benefits and cost-effectiveness in patients with severe systemic morbidity. Methods. Data from the National Joint Registry for England, Wales and Northern Ireland was linked to hospital inpatient and patient-reported outcomes data. Patients with American Society of Anesthesiologists (ASA) grade ≥3 undergoing UKR or TKR were identified. Propensity score stratification was used to compare 90-day complications and 5-year revision and mortality of 2,256 UKR and 57,682 TKR, and in a subset of 145 UKR and 23,344 TKR Oxford Knee Scores (OKS). A health-economic analysis was based on EQ-5D and NHS hospital costs. Results. The OKS was significantly better following UKR than TKR with a difference of 1.83 (95%CI 0.10–3.56). UKR was associated with lower relative risks of venous thromboembolism (0.33, CI0.15–0.74), myocardial infarction (0.73, CI0.36–1.45) and early joint infection (0.85, CI0.33–2.19) but only the decrease in venous thromboembolism was significant. The revision risk following UKR was significantly higher than following TKR (hazard ratio 2.70, CI2.15–3.38) and the mortality was significantly lower (0.52, CI0.36–0.74). At five years the cumulative incidence of revision was 8% higher with UKR, and the cumulative incidence of death was 13% lower. The health economic analysis found that UKR dominated TKR having lower costs (£359, CI340-378) and higher quality-of-life gains (0.33, CI-0.31–0.970). Conclusions. For patients with ASA ≥3, UKR was safer and more cost-effective than TKR. In particular if UKR was used instead of TKR the number of lives saved was higher than the number of extra revisions. UKR should be considered the first option for suitable patients with severe co-morbidity


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 832 - 837
1 Jul 2019
Shim J Hamilton DF

Aims. Responsiveness to clinically important change is a key feature of any outcome measure. Throughout Europe, health-related quality of life following total knee arthroplasty (TKA) is routinely measured with EuroQol five-dimension (EQ-5D) questionnaires. The Patient-Reported Outcomes Measurement Information System 10-Question Short-Form (PROMIS-10 Global Health) score is a new general heath outcome tool which is thought to offer greater responsiveness. Our aim was to compare these two tools. Patients and Methods. We accessed data from a prospective multicentre cohort study in the United Kingdom, which evaluated outcomes following TKA. The median age of the 721 patients was 69.0 years (interquartile range, 63.3 to 74.6). There was an even division of sex, and approximately half were educated to secondary school level. The preoperative EQ-5D, PROMIS-10, and Oxford Knee Scores (OKS) were available and at three, six, and 12 months postoperatively. Internal responsiveness was assessed by standardized response mean (SRM) and effect size (Cohen’s d). External responsiveness was assessed by correlating change scores of the EQ-5D and PROMIS-10, with the minimal clinically important difference (MCID) of the OKS. Receiver operating characteristic (ROC) curves were used to assess the ability of change scores to discriminate between improved and non-improved patients. Results. All measures showed significant changes between the preoperative score and the various postoperative times (p < 0.001). Most improvement occurred during the first three months, with small but significant changes between three and six months, and no further change between six and 12 months postoperatively. SRM scores for EQ-5D, PROMIS-10, and OKS were large (> 0.8). ROC curves showed that both EQ-5D and PROMIS-10 were able to discriminate between patients who achieved the OKS MCID and those who did not (area under the curve (AUC) of 0.7 to 0.82). Conclusion. The PROMIS-10 physical health tool showed greater responsiveness to change than the EQ-5D, most probably due to the additional questions on physical health parameters that are more susceptible to modification following TKA. The EQ-5D was, however, shown to be sensitive to clinically meaningful change following TKA, and provides the additional ability to calculate health economic utility scores. It is likely, therefore, that EQ-5D will continue to be the global health metric of choice in the United Kingdom. Cite this article: Bone Joint J 2019;101-B:832–837


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIX | Pages 70 - 70
1 Jul 2012
Erturan G Neely J Richards N Price A Jackson W Khan T
Full Access

A feasibility study of the use of an MRI based patient specific knee arthroplasty system within the NHS. Introducing new technologies within a public funded health system can be challenging. We assess the use and potential benefit of customised jigs for knee arthroplasty. Outcomes assessed were safety and accuracy of implantation. Eight knee replacements using custom jigs were compared to 11 conventionally instrumented replacements matched to surgeon and operative day. Parameters measured include tourniquet time; drain output; hospital stay; adjusted change in haemoglobin; complications; and component position on post-operative long-leg alignment films. None of the parameters observed demonstrated a statistically significant difference from the conventional arthroplasty group. No complications were seen in either group. No significant differences were seen in alignment. Our early experiences show that this technology appears safe and allows accurate implantation of the prosthesis. There was a trend for decreased stay and blood loss. The health economic benefits of navigational arthroplasty have been demonstrated in other studies and come from the lack of instrumentation of the intramedullary canal. MRI based patient specific instrumentation is considered technically easier and more convenient than intra-operative navigation. A larger study is planned to assess the health economic implications of adopting this new technology


Bone & Joint Open
Vol. 5, Issue 7 | Pages 550 - 559
5 Jul 2024
Ronaldson SJ Cook E Mitchell A Fairhurst CM Reed M Martin BC Torgerson DJ

Aims

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).

Methods

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.


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 864 - 871
3 May 2021
Hunt LP Matharu GS Blom AW Howard PW Wilkinson JM Whitehouse MR

Aims

Debate remains whether the patella should be resurfaced during total knee replacement (TKR). For non-resurfaced TKRs, we estimated what the revision rate would have been if the patella had been resurfaced, and examined the risk of re-revision following secondary patellar resurfacing.

Methods

A retrospective observational study of the National Joint Registry (NJR) was performed. All primary TKRs for osteoarthritis alone performed between 1 April 2003 and 31 December 2016 were eligible (n = 842,072). Patellar resurfacing during TKR was performed in 36% (n = 305,844). The primary outcome was all-cause revision surgery. Secondary outcomes were the number of excess all-cause revisions associated with using TKRs without (versus with) patellar resurfacing, and the risk of re-revision after secondary patellar resurfacing.


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1561 - 1570
1 Oct 2021
Blyth MJG Banger MS Doonan J Jones BG MacLean AD Rowe PJ

Aims

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.

Methods

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.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 627 - 634
1 Apr 2021
Sabah SA Alvand A Beard DJ Price AJ

Aims

To estimate the measurement properties for the Oxford Knee Score (OKS) in patients undergoing revision knee arthroplasty (responsiveness, minimal detectable change (MDC-90), minimal important change (MIC), minimal important difference (MID), internal consistency, construct validity, and interpretability).

Methods

Secondary data analysis was performed for 10,727 patients undergoing revision knee arthroplasty between 2013 to 2019 using a UK national patient-reported outcome measure (PROM) dataset. Outcome data were collected before revision and at six months postoperatively, using the OKS and EuroQol five-dimension score (EQ-5D). Measurement properties were assessed according to COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) guidelines.


The Bone & Joint Journal
Vol. 102-B, Issue 9 | Pages 1176 - 1182
14 Sep 2020
Mathews JA Kalson NS Tarrant PM Toms AD

Aims

The James Lind Alliance aims to bring patients, carers, and clinicians together to identify uncertainties regarding care. A Priority Setting Partnership was established by the British Association for Surgery of the Knee in conjunction with the James Lind Alliance to identify research priorities related to the assessment, management, and rehabilitation of patients with persistent symptoms after knee arthroplasty.

Methods

The project was conducted using the James Lind Alliance protocol. A steering group was convened including patients, surgeons, anaesthetists, nurses, physiotherapists, and researchers. Partner organizations were recruited. A survey was conducted on a national scale through which patients, carers, and healthcare professionals submitted key unanswered questions relating to problematic knee arthroplasties. These were analyzed, aggregated, and synthesized into summary questions and the relevant evidence was checked. After confirming that these were not answered in the current literature, 32 questions were taken forward to an interim prioritization survey. Data from this survey informed a shortlist taken to a final consensus meeting.


Bone & Joint Research
Vol. 3, Issue 7 | Pages 217 - 222
1 Jul 2014
Robertsson O Ranstam J Sundberg M W-Dahl A Lidgren L

We are entering a new era with governmental bodies taking an increasingly guiding role, gaining control of registries, demanding direct access with release of open public information for quality comparisons between hospitals. This review is written by physicians and scientists who have worked with the Swedish Knee Arthroplasty Register (SKAR) periodically since it began. It reviews the history of the register and describes the methods used and lessons learned.

Cite this article: Bone Joint Res 2014;3:217–22.