Further reflections on TOPKAT and Partial vs. Total Knee Replacement-response to authors.
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SUBMITTER: Beard DJ
PROVIDER: S-EPMC7327336 | biostudies-literature | 2020 Jun
REPOSITORIES: biostudies-literature
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Further reflections on TOPKAT and Partial <i>vs</i>. Total Knee Replacement-response to authors.
Beard David J DJ Price Andrew J AJ Campbell Marion K MK
Annals of translational medicine 20200601 11
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Project description:BackgroundIn the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two fundamentally different approaches to knee replacement for patients with unicompartmental disease: some surgeons feel that it is always best to replace both the knee compartments with a total knee replacement (TKR); whereas others feel it is best to replace just the damaged component of the knee using a partial or unicompartment replacement (UKR). Both interventions are established and well-documented procedures. Little evidence exists to prove the clinical and cost-effectiveness of either management option. This provides an explanation for the high variation in treatment of choice by individual surgeons for the same knee pathology.The aim of the TOPKAT study will be to assess the clinical and cost effectiveness of TKRs compared to UKRs in patients with medial compartment osteoarthritis.Methods/designThe design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. Blinding will not be possible as the surgical scars for each procedure differ.We aim to recruit 500 patients from approximately 28 secondary care orthopaedic units from across the UK including district general and teaching hospitals. Participants will be randomised to either UKR or TKR. Randomisation will occur using a web-based randomisation system. The study is pragmatic in terms of implant selection for the knee replacement operation. Participants will be followed up for 5 years. The primary outcome is the Oxford Knee Score, which will be collected via questionnaires at 2 months, 1 year and then annually to 5 years. Secondary outcomes will include cost-effectiveness, patient satisfaction and complications data.Trial registrationCurrent Controlled Trials ISRCTN03013488; ClinicalTrials.gov Identifier: NCT01352247.
| S-EPMC3848560 | biostudies-literature
Project description:Background and purposeIt is unclear whether mobile-bearing (MB) total knee arthroplasties reduce the risk of tibial component loosening compared to fixed-bearing (FB) designs. This randomized study investigated implant migration, periprosthetic bone mineral density (BMD), and patient-reported outcomes (Oxford knee score)-all at 2 years-for the P.F.C. Sigma Cruciate Retaining total knee arthroplasty.Patients and methods50 osteoarthritis patients were allocated to either FB or MB tibial articulation.Results and interpretationAt 2 years, the mean total translation (implant migration) was higher for the FB implant (0.30 mm, SD 0.22) than for the MB implant (0.17 mm, SD 0.09) (p = 0.04). BMD decreased between baseline and 1-year follow-up. At 2-year follow-up, BMD was close to the baseline level. The knee scores of both groups improved equally well. The FB tibial implant migrated more than the MB, but this was not clinically significant. The mobile polyethylene presumably partly absorbs the force transmitted to the metal tibial tray, thereby reducing micromotion.
| S-EPMC4404772 | biostudies-literature
Project description: Not available
| S-EPMC7327312 | biostudies-literature
Project description:BackgroundLate-stage isolated medial knee osteoarthritis can be treated with total knee replacement (TKR) or partial knee replacement (PKR). There is high variation in treatment choice and little robust evidence to guide selection. The Total or Partial Knee Arthroplasty Trial (TOPKAT) therefore aims to assess the clinical effectiveness and cost-effectiveness of TKR versus PKR in patients with medial compartment osteoarthritis of the knee, and this represents an analysis of the main endpoints at 5 years.MethodsOur multicentre, pragmatic randomised controlled trial was done at 27 UK sites. We used a combined expertise-based and equipoise-based approach, in which patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR were randomly assigned (1:1) to receive PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure. The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups. Health-care costs (in UK 2017 prices) and cost-effectiveness were also assessed. This trial is registered with ISRCTN (ISRCTN03013488) and ClinicalTrials.gov (NCT01352247).FindingsBetween Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45%) patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients were randomly assigned to groups. 94% of participants responded to the follow-up survey 5 years after their operation. At the 5-year follow-up, we found no difference in OKS between groups (mean difference 1·04, 95% CI -0·42 to 2·50; p=0·159). In our within-trial cost-effectiveness analysis, we found that PKR was more effective (0·240 additional quality-adjusted life-years, 95% CI 0·046 to 0·434) and less expensive (-£910, 95% CI -1503 to -317) than TKR during the 5 years of follow-up. This finding was a result of slightly better outcomes, lower costs of surgery, and lower follow-up health-care costs with PKR than TKR.InterpretationBoth TKR and PKR are effective, offer similar clinical outcomes, and result in a similar incidence of re-operations and complications. Based on our clinical findings, and results regarding the lower costs and better cost-effectiveness with PKR during the 5-year study period, we suggest that PKR should be considered the first choice for patients with late-stage isolated medial compartment osteoarthritis.FundingNational Institute for Health Research Health Technology Assessment Programme.
| S-EPMC6727069 | biostudies-literature
Project description:BackgroundTotal knee arthroplasty is a common surgery for end-stage knee osteoarthritis. Partial knee arthroplasty is also a treatment option for patients with arthritis present in only one or two knee compartments. Partial knee arthroplasty can preserve the natural knee biomechanics, but these replacements may not last as long as total knee replacements. Robotic-assisted orthopedic techniques can help facilitate partial knee replacements, increasing accuracy and precision. This trial will investigate the feasibility and assess clinical outcomes for a larger definitive trial.MethodsThis is a protocol for an ongoing parallel randomized pilot trial of 64 patients with uni- or bicompartmental knee arthritis. Patients are randomized to either receive robot-assisted partial knee arthroplasty or manual total knee arthroplasty. The primary outcome of this pilot is investigating the feasibility of a larger trial. Secondary (clinical) outcomes include joint awareness, return to activities, knee function, patient global impression of change, persistent post-surgical pain, re-operations, resource utilization and cost-effectiveness, health-related quality of life, radiographic alignment, knee kinematics during walking gait, and complications up to 24 months post-surgery.DiscussionThe RoboKnees pilot study is the first step in determining the outcome of robot-assisted partial knee replacements. Conclusions from this study will be used to design future large-scale trials. This study will inform surgeons about the potential benefits of robot-assisted partial knee replacements.Trial registrationThis study was prospectively registered on clinicaltrials.gov (identifier: NCT04378049) on 4 May 2020, before the first patient was randomized.
| S-EPMC10880336 | biostudies-literature
Project description:PurposeFor patients with end-stage knee osteoarthritis, joint replacement is a widely used and successful operation to help improve quality-of-life when non-operative measures have failed. For a significant proportion of patients there is a choice between a partial or total knee replacement. Decision aids can help people weigh up the need for and benefits of treatment against possible risks and side-effects. This study explored patients' experiences of deciding to undergo knee replacement surgery to identify information priorities, to inform a knee replacement decision aid.MethodsFour focus groups were held with 31 patients who were candidates for both partial and total knee replacement surgery. Two focus groups included patients with no prior knee replacement surgery (pre-surgery); two with patients with one knee already replaced and who were candidates for a second surgery on their other knee (post-surgery). Data were analysed using Framework Analysis.ResultsParticipants described a process of arriving at 'readiness for surgery' a turning point where the need for treatment outweighed their concerns. Referral and personal factors influenced their decision-making and expectations of surgery in the hope to return to a former self. Those with previous knee surgery offered insights into whether their expectations were met. 'Information for decisions' details the practicality and the optimal timing for the delivery of a knee replacement decision aid. In particular, participants would have valued hearing about the experiences of other patients and seeing detailed pictures of both surgical options. Information priorities were identified to include in a decision aid for knee replacement surgery.ConclusionsPatients' experiences of surgical decision-making have much in common with the Necessity-Concerns Framework. Whilst originally developed to understand drug treatment decisions and adherence, it provides a useful lens to understand decision-making about surgery. The use of a decision aid could enhance decision-making on knee replacement surgery. Ultimately, patients' understanding of the risks and benefits of both surgical options could be improved and in turn, help informed decision-making. The knee replacement decision aid is perceived as a useful tool to be associated with other detailed information resources as recommended.
| S-EPMC7142054 | biostudies-literature
Project description:BackgroundAs robot-assisted equipment is continuously being used in orthopaedic surgery, the past few decades have seen an increase in the usage of robotics for total knee arthroplasty (TKA). Thus, the purpose of the present study is to investigate the differences between robotic TKA and nonrobotic TKA on perioperative and postoperative complications and opioid consumption.MethodsAn administrative database was queried from 2010 to Q2 of 2017 for primary TKAs performed via robot-assisted surgery vs non-robot-assisted surgery. Systemic and joint complications and average morphine milligram equivalents were collected and compared with statistical analysis.ResultsPatients in the nonrobotic TKA cohort had higher levels of prosthetic revision at 1-year after discharge (P < .05) and higher levels of manipulation under anesthesia at 90 days and 1-year after discharge (P < .05). Furthermore, those in the nonrobotic TKA cohort had increased occurrences of deep vein thrombosis, altered mental status, pulmonary embolism, anemia, acute renal failure, cerebrovascular event, pneumonia, respiratory failure, and urinary tract infection during the inpatient hospital stay (all P < .05) and at 90 days after discharge (all P < .05). All of these categories remained statistically increased at the 90-days postdischarge date, except pneumonia and stroke. Patients in the nonrobotic TKA cohort had higher levels of average morphine milligram equivalents consumption at all time periods measured (P < .001).ConclusionsIn the present study, the use of robotics for TKA found lower revision rates, lower incidences of manipulation under anesthesia, decreased occurrence of systemic complications, and lower opiate consumption for postoperative pain management. Future studies should look to further examine the long-term outcomes for patients undergoing robot-assisted TKA.Level of evidenceLevel III.
| S-EPMC7772451 | biostudies-literature
Project description:Pain is the main impetus for osteoarthritis (OA) patients to seek healthcare including joint replacement. The pain experience in OA is heterogeneous and affected by factors across multiple domains-peripheral, psychological, and neurological. This indicates the existence of homogenous subgroups/phenotypes within OA patients with pain. We recently identified three pain phenotypes using a wide spectrum of pain-related factors, including structural damage on magnetic resonance imaging (MRI), emotional problems, number of painful sites, sex, body mass index, education level and comorbidities (i.e., Class 1: high prevalence of emotional problems and low prevalence of structural damage (25%); Class 2: low prevalence of emotional problems and high prevalence of structural damage (20%); Class 3: low prevalence of emotional problems and low prevalence of structural damage (55%)). This study was to examine whether the total knee replacement (TKR) risk over 12 years was different among these three pain phenotypes. Data on 963 participants (mean age 62.8 ± 7.4 years) from a population-based cohort study were utilised. Data on socio-demographic, psychological and comorbidities were collected. MRI of the right knee structural pathology was performed. TKR history was ascertained by linking to the Australian Orthopedic Association National Joint Replacement Registry. Latent class analysis and the Cox proportional hazards model were applied for the analysis. During the follow-up period, 41 right and 44 left TKRs in 67 participants were identified. In multivariable analyses, participants in Class 1 and 2 had a higher risk of having a TKR (Class 1 vs. Class 3, HR (hazard ratio) 4.81, 95%CI (confidence interval) 2.33-9.93; Class 2 vs. Class 3, HR 9.23, 95%CI 4.66-18.30). These associations were stronger in the imaged right knee but were also significant in the left knee. Participants within distinct pain phenotypes have different risks of TKR, suggesting that the identified phenotypes reflect distinct clinical subgroups with different prognoses. The risk for TKR was higher in Class 1 than that in Class 3, suggesting that pain/emotional status is a stronger driver for TKR than structural damage, and that selecting patients for TKR needs to be optimized in clinical practice.
| S-EPMC7141124 | biostudies-literature
Project description:Background and purpose - Aseptic loosening is a main cause of late revision in total knee replacement (TKR). Migration of implants as measured by radiostereometric analysis (RSA) can predict future loosening. This migration is associated with bone resorption. Denosumab is a human monoclonal antibody that binds to receptors on osteoclast precursors and osteoclasts. This prevents osteoclast formation, resulting in less bone resorption in cortical and trabecular bone. We investigated whether denosumab can reduce migration of TKR, as measured with RSA. Patients and methods - In this 2-center, randomized, double-blind placebo-controlled trial, 50 patients with osteoarthritis of the knee were treated with an injection of either denosumab (60 mg) or placebo 1 day after knee replacement surgery and again after 6 months. RSA was performed postoperatively and after 6, 12, and 24 months. The primary effect variable was RSA maximal total point motion (MTPM) after 12 months. We also measured other RSA variables and the knee osteoarthritis outcome score (KOOS). Results - The primary effect variable, MTPM after 12 months, showed that migration in the denosumab group was statistically significantly less than in the controls. Denosumab MTPM 12 months was reduced by one-third (denosumab: median 0.24 mm, 10% and 90% percentiles: 0.15 and 0.41; placebo: median 0.36 mm, 10% and 90% percentiles: 0.20 and 0.62). The secondary MTPM variables (6 and 24 months) also showed a statistically significant reduction in migration. There was no significant difference in MTPM for the period 12-24 months. KOOS sub-variables were similiar between denosumab and placebo after 12 and 24 months. Interpretation - Denosumab reduces early migration in total knee replacement, as in previous trials using bisphosphonates. As migration is related to the risk of late loosening, denosumab may be beneficial for long-term results.
| S-EPMC5434591 | biostudies-literature
Project description:BackgroundCutaneous and local reactions to metals used in orthopaedic implants have been well documented. The prevalence of metal sensitivity in general population is 10%-15%. Nickel, Cobalt and Chromium are the most common allergen. The association between cutaneous reactions and implants has been less understood. Hence, this study was taken up with the aim to assess the prevalence of metal hypersensitivity in Total Knee Replacement (TKR) patients and find the most prevalent allergen.Materials & methodsLongitudinal study conducted during January-December 2017. We enrolled 233 subjects who were at least three months postoperative. Radiological assessment was done. CREDISOL® kit was used for patch test. Results were recorded using ICDRG grading at 48 hours and five days.ResultsMean age was 59.59 years; 12.01% were symptomatic. Pain followed by loss of function were the most common symptoms. However, loss of function and patient dissatisfaction towards procedure were significantly associated with metal hypersensitivity (χ2 value > 3.84; p value < 0.05). In 66% subjects, pre-operative diagnosis was severe osteoarthritis, followed by rheumatoid arthritis (23%). None of the subjects had evidence of loosening on X-ray. Prevalence of Metal Hypersensitivity was found to be 15.87% (patch test positive). Chromium (11.58%) was found to be most common allergen followed by Nickel (8.58%) and then Cobalt (6.43%).ConclusionsSignificant prevalence of metal hypersensitivity was found. Therefore, we recommend pre-operative patch test for detecting allergic reactions to implants. Alternatives like Titanium or Zirconium can be used to avoid complications.
| S-EPMC6818373 | biostudies-literature