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Functional outcome of total knee replacement: a study protocol for a prospective, double-blinded, parallel-group randomized, clinical controlled trial of novel, personalized and conventional implants.

ABSTRACT: BACKGROUND:The development of total knee replacement (TKR) implant designs aims to improve outcome regarding pain, function, joint stiffness, instability, patellar problems, and ultimately wear of the implant. Recently, two major orthopaedic implant manufacturers launched a new generation of TKR implants which, according to the manufacturers, provide improved functional outcome. However, the benefits of these new TKR designs claimed by the manufacturers in terms of improved functional outcome still lack scientific documentation. The present randomized controlled trial has been designed to compare three fixed bearing, cemented cruciate-retaining (CR) designs; one of the new personalized TKR design with two conventional TKR designs with the main emphasis being on functional outcome. METHODS:The present study is a prospective, double-blinded, randomized, single-center intervention trial. A total of 240 patients will be recruited to participate in a parallel-group study at Coxa Hospital for Joint Replacement, Tampere, Finland. We will compare the short-term functional outcome of TKR performed with a novel personalized TKR design (Persona CR, Zimmer, Warsaw, IN, USA) against TKRs performed with two conventional designs (PFC CR, DePuy, Warsaw, IN, USA and Nexgen CR, Zimmer, Warsaw, IN, USA). In total, 80 patients will be randomized in each of the three study arms. The primary outcome in this study is the Oxford Knee Score (OKS), which is a validated patient-reported outcome measure (PROM). Secondary outcome measures include the Forgotten Joint Score, the 15D, the UCLA activity score, and the VAS pain scale. The results will be analyzed after 2-year follow-up. DISCUSSION:This paper presents a prospective, randomized, single-center trial study protocol. It provides details of patient randomization, PROMs, follow-up, methods of analysis of the material, and publication plan. An important aspect that will be considered in the study will be the economic effects of the novel designs as they are substantially more expensive, and the benefits of the added costs remain unknown. In addition, it is especially important to carry out evaluative studies in independent centers that are not biased by the interests of the manufacturers. TRIAL REGISTRATION:Retrospectively registered, November, 2017, ClinicalTrials.gov Identifier: NCT03339557 .

SUBMITTER: Irmola T

PROVIDER: S-EPMC6790022 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Functional outcome of total knee replacement: a study protocol for a prospective, double-blinded, parallel-group randomized, clinical controlled trial of novel, personalized and conventional implants.

Irmola T T Kangas J J Eskelinen A A Niemeläinen M M Huhtala H H Mattila V M VM Moilanen T T

BMC musculoskeletal disorders 20191012 1

<h4>Background</h4>The development of total knee replacement (TKR) implant designs aims to improve outcome regarding pain, function, joint stiffness, instability, patellar problems, and ultimately wear of the implant. Recently, two major orthopaedic implant manufacturers launched a new generation of TKR implants which, according to the manufacturers, provide improved functional outcome. However, the benefits of these new TKR designs claimed by the manufacturers in terms of improved functional ou ...[more]

PMID: 31604440

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Project description:BackgroundImproving functional status preoperatively through exercise may improve postoperative outcome. Previous knowledge on preoperative exercise in knee osteoarthritis is insufficient. The aim of the study was to compare the difference in change between groups in lower extremity function from baseline to 3 months after Total Knee Replacement (TKR) following a neuromuscular exercise programme (NEMEX-TJR) plus a knee school educational package (KS) or KS alone.Methods45 patients (55-83 years, 53% male, waiting for TKR) were randomized to receive a minimum of 8 sessions of NEMEXTJR plus 3 sessions of KS or 3 sessions of KS alone. Function was assessed with the Chair Stand Test (CST, primary endpoint) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales focusing on daily living function (ADL) and pain (secondary endpoints). Assessments were performed immediately before and after the intervention, and at 6 weeks, 3 months and 12 months after surgery by a physiotherapist, blinded to group allocation.ResultsAfter intervention before surgery we observed a small improvement for primary and secondary endpoints in both groups, which did not differ significantly between groups: comparing the exercise to the control group the treatment effect for the CST was -1.5 seconds (95% CI: -5.3, 2.2), for KOOS ADL and KOOS pain the treatment effect was 1.3 points (-10.1, 12.8) and -2.3 (-12.4, 7.9) respectively. At 3 months after surgery we observed a small improvement in the primary endpoint in the control group and a significant improvement in the secondary endpoints in both exercise and control groups, which did not differ significantly between groups: comparing the exercise group to the control group the treatment effect in the CST was 2.0 seconds (-1.8, 5.8), for KOOS ADL and KOOS pain the treatment effect was -4.9 points (-16.3, 6.5) and -3.3 points (-13.5, 6.8) respectively.ConclusionsA median (IQR) of 10 (8, 14) exercise sessions before surgery showed an additional small but non-significant improvement in all functional assessments compared to patient education alone. These benefits were not sustained after TKR. Our trial doesn't give a conclusive answer to whether additional preoperative exercise on postoperative functional outcomes is beneficial.

Project description:BackgroundTotal knee arthroplasty (TKA) with mechanical alignment (MA) aims to achieve neutral limb alignment in all patients, whereas TKA with functional alignment (FA) aims to restore native, patient-specific anatomy and knee kinematics by manipulating bone resections and fine-tuning implant positioning. The objective of this study is to determine the optimal alignment technique in TKA by comparing patient satisfaction, functional outcomes, implant survivorship, complications, and cost-effectiveness in MA TKA versus FA TKA. Robotic technology will be used to execute the planned implant positioning and limb alignment with high-levels of accuracy in all study patients.Methods and analysisThis prospective double-blinded randomised control trial will include 100 patients with symptomatic knee osteoarthritis undergoing primary robotic arm-assisted TKA. Following informed consent, patients will be randomised to MA TKA (the control group) or FA TKA (the investigation group) at a ratio of 1:1 using an online random number generator. Blinded observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning and limb alignment, gait, implant stability, cost-effectiveness, and complications. A superiority study design will be used to evaluate whether FA TKA provides superior outcomes compared to MA TKA. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Surrey Research Ethics Committee, UK. The study is sponsored by University College London, UK.DiscussionThis is the first study to describe the use of robotic technology to achieve FA TKA, and the only existing clinical trial comparing robotic MA TKA versus robotic FA TKA. The findings of this study will enable an improved understanding of the optimal alignment technique in TKA for achieving high-levels of patient satisfaction, improving functional outcomes, increasing implant survivorship, improving cost-effectiveness, and reducing complications.RegistrationClinical Trials.gov, NCT04092153. Registered on 17 September 2019.

Project description:IntroductionIn Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence.Methods and analysisThis is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study.Ethics and disseminationThe study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media.Trial registration numberEudraCT: No 2015-001200-55; Pre-results.

Dataset Information

Functional outcome of total knee replacement: a study protocol for a prospective, double-blinded, parallel-group randomized, clinical controlled trial of novel, personalized and conventional implants.

Publications

Functional outcome of total knee replacement: a study protocol for a prospective, double-blinded, parallel-group randomized, clinical controlled trial of novel, personalized and conventional implants.

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