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Do patients care about higher flexion in total knee arthroplasty? A randomized, controlled, double-blinded trial.

ABSTRACT: Little information exists to support that patients care about flexion beyond what is needed to perform activities of daily living (ADL) after Total knee arthroplasty (TKA). The purpose of this study was to investigate if the achievement of a higher degree of knee flexion after TKA would result in a better patient perceived outcome.The study is a randomized, double-blinded, controlled trial in which 36 patients (mean age: 67.2 yrs) undergoing one-stage bilateral TKA randomly received a standard cruciate-retaining (CR) TKA in one knee and a high-flex posterior-stabilized (PS) TKA in the contra lateral knee. At follow-up ROM, satisfaction, pain, "feel" of the knee and the abilities in daily activities were assessed.At 1-year follow-up we found an expected significantly higher degree of knee flexion of 7° in the high-flex knees (p = 0.001). The high-flex TKA's showed a mean active flexion of 121°. In both TKA's the median VAS pain score was 0, the median VAS satisfaction score was 9, and the median VAS score of the patient "feel" of the knee was 9 at 1-year follow-up. Further, there were no significant differences between the knees in the performance of daily activities.As expected the high-flex TKA showed increased knee flexion, but no significant differences in the patient perceived outcomes were found. This suggests little relevance to the patients of the difference in knee flexion - when flexion is of this magnitude - as pain free ROM and high patient satisfaction were achieved with both TKA's.ClinicalTrials.gov: NCT00294528.

SUBMITTER: Thomsen MG

PROVIDER: S-EPMC3637231 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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Do patients care about higher flexion in total knee arthroplasty? A randomized, controlled, double-blinded trial.

Thomsen Morten G MG Husted Henrik H Otte Kristian S KS Holm Gitte G Troelsen Anders A

BMC musculoskeletal disorders 20130408

<h4>Background</h4>Little information exists to support that patients care about flexion beyond what is needed to perform activities of daily living (ADL) after Total knee arthroplasty (TKA). The purpose of this study was to investigate if the achievement of a higher degree of knee flexion after TKA would result in a better patient perceived outcome.<h4>Methods</h4>The study is a randomized, double-blinded, controlled trial in which 36 patients (mean age: 67.2 yrs) undergoing one-stage bilateral ...[more]

PMID: 23565578

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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.

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Do patients care about higher flexion in total knee arthroplasty? A randomized, controlled, double-blinded trial.

Publications

Do patients care about higher flexion in total knee arthroplasty? A randomized, controlled, double-blinded trial.

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