Movement pattern biofeedback training after total knee arthroplasty: Randomized clinical trial protocol.
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ABSTRACT: Introduction
Total knee arthroplasty (TKA) reduces joint symptoms, but habitual movement compensations persist years after surgery. Preliminary research on movement training interventions have signaled initial efficacy for remediating movement compensations and restoring knee joint loading symmetry during dynamic functional tasks after TKA. The purpose of this clinical trial is to determine if physical rehabilitation that includes movement training restores healthy movement patterns after TKA and reduces the risk of osteoarthritis (OA) progression in the contralateral knee.Methods/design
150 participants will be enrolled into this randomized controlled trial. Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL). Movement training will promote between-limb symmetry and surgical knee loading during activity-based exercises. Movement training strategies will include real-time biofeedback using in-shoe pressure sensors and verbal, visual, and tactile cues from the physical therapist. The primary outcome will be change in peak knee extension moment in the surgical knee during walking, from before surgery to six months after surgery. Secondary outcomes will include lower extremity movement symmetry during functional tasks, physical function, quadriceps strength, range of motion, satisfaction, adherence, contralateral knee OA progression, and incidence of contralateral TKA.Discussion
This study will provide insights into the efficacy of movement training after unilateral TKA, along with mechanisms for optimizing long-term physical function and minimizing negative sequelae of compensatory movement patterns.
SUBMITTER: Bade MJ
PROVIDER: S-EPMC7263966 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Study designRandomized controlled trial.ObjectivesTo examine the effects of weight-bearing biofeedback training on weight-bearing symmetry and functional joint moments following unilateral total knee arthroplasty.BackgroundIndividuals after unilateral total knee arthroplasty place more weight on the nonsurgical limb compared to the surgical limb during function. It is unknown whether targeted intervention can improve function in the surgical limb and resolve altered movement patterns.MethodsTwenty-six patients were randomly assigned to 2 groups (reload or control). The reload group had a standard-of-care rehabilitation augmented with weight-bearing biofeedback training, and the control group had a dose-matched standard-of-care rehabilitation. Lower-limb weight-bearing ratios were measured preoperatively and 6 and 26 weeks after total knee arthroplasty during a 5-time sit-to-stand test (FTSST) and walking. Secondary outcomes were FTSST time, walking speed, and lower-limb joint moments during the FTSST and walking.ResultsNo between-group differences were found in weight-bearing ratios. Five-time sit-to-stand test time improved in the reload group compared to the control group at 6 (P = .021) and 26 weeks (P = .021). There were no between-group differences in knee extension moment during the FTSST. Surgical-limb knee extension moments during walking increased from baseline to 26 weeks in the reload group and decreased in the control group (P = .008).ConclusionWeight-bearing biofeedback training had no effect on functional weight-bearing symmetry or knee extension moments during the FTSST. However, the biofeedback training resulted in increases of knee extension moments during gait and improved FTSST times. Trial registered at ClinicalTrials.gov (NCT01333189). Level of Evidence Therapy, level 2b.
| S-EPMC4558346 | biostudies-literature
Project description:Purpose The effects of the commonly utilized intraoperative tourniquet on gene expression within the skeletal muscle cells are barely examined. Our group already showed that tourniquet application results in higher proteolytic activity within vastus medialis cells (KSSTA 2016), without influence on the amount and function of mitochondria (EJOT 2016). The purpose of the present study was to examine the gene expression within the skeletal muscle cells after tourniquet-induced ischemia and to identify differential expressed genes (DEGs). Methods As part of a randomized, controlled, monocentric trial (Clinical-Trials.gov NCT02475603) we included 20 patients scheduled to undergo primary total knee arthroplasty (TKA). The patients received a written consent and were randomly assigned to Group A (TKA with tourniquet) (n=10) and Group B (TKA without tourniquet) (n=10). Muscle biopsies of (5×5×5 mm) were obtained from the vastus medialis immediately after performing the surgical approach and exactly 60 min later. After preparation of a muscle homogenate, RNA extraction was performed (RNeasy Plus Universal Mini Kit Qiagen) and RNA integrity (RIN) was determined (Agilent 2100 Bioanalyzer,RNA 6000 Pico Kit). Gene expression profiling was performed methodological validated (GeneChip™ Human Transcriptome Array 2.0;Affymetrix). Statistical analysis include the number of significant DEGs with p-value < 0,05, number of DEGs with relative difference >25% and pathway analysis (SPSS-Version 24; SAS JMP10 Genomics, Version 6). The power analysis considered an effect size of 0,4 and a statistical power > 0,8, sample size n=10 for each group. The protocol was approved by our Institutional Ethics Committee (File reference 2012-334N-MA). Results and conclusion Numerous genes were differencially expressed during tourniquet induced ischemia. Further investigations and statistical analysis are ongoning.
2021-01-01 | GSE124595 | GEO
Project description:BACKGROUND:Patients with knee osteoarthritis (OA) report knee pain, limitation in physical activities and low quality of life. The two primary treatments for knee OA are non-surgical treatment (e.g., exercise) and surgery (total knee arthroplasty (TKA)); however, national guidelines recommend non-surgical treatment to be tried prior to surgical procedures. Patients with knee OA are characterized by decreased muscle strength, particularly in the knee-extensor muscles. Correspondingly, decreased knee-extensor strength is found to be associated with an increased risk of development, progression and severity of knee OA symptoms. Recent trials suggest a positive effect of pre-operative exercise on pre- and post-operative outcome; however, the most effective pre-operative knee-extensor strength exercise dosage is not known. The purpose of the present trial is to investigate the efficacy of three different exercise dosages of pre-operative, home-based, knee-extensor strength exercise on knee-extensor strength before and shortly after surgery in patients eligible for TKA due to end-stage knee OA. METHODS:In this randomized dose-response trial with a three-arm parallel design, 140 patients with end-stage knee OA (candidates for TKA) are randomized to one of three exercise dosages (two, four or six session/week) of knee-extensor strength exercise (three sets, 12 repetitions at 12 RM, per exercise session) for 12 weeks. The knee-extensor strength exercise is home-based (unsupervised) and performed with an elastic exercise band following an initial exercise instruction. Adherence is objectively quantified using a sensor attached to the exercise band. The primary outcome will be the change in knee-extensor strength. Following the 12-week exercise period, the need for TKA surgery is re-assessed by an orthopedic surgeon. DISCUSSION:Decreased knee-extensor strength is a major challenge in patients with knee OA. Exercise programs focusing on knee-extensor strength are found to be more effective in relieving knee OA pain and symptoms compared to more general exercise programs. However, the optimal exercise dosage for knee-extensor strength deficits in patients with knee OA is inconclusive. Knowledge on the dose-response relationship for knee-extensor strength exercise in patients with knee OA will help guide future non-surgical treatment in this patient population. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02931058 . Pre-registered on 10 October 2016.
| S-EPMC5774158 | biostudies-literature
Project description:Ischaemic preconditioning is a method of protecting tissue against ischaemia-reperfusion injury. It is an innate protective mechanism that increases a tissue's tolerance to prolonged ischaemia when it is first subjected to short burst of ischaemia and reperfusion. It is thought to provide this protection by increasing the tissue's tolerance to ischaemia, therby reducing oxidative stress, inflammation and apoptosis in the preconditioned tissue. We used microarrays to investigate the genomic response induced by ischaemic preconditioning in muscle biopsies taken from the operative leg of total knee arthroplasty patients in order to gain insight into the ischaemic preconditioning mechanism. Patients undergoing primary knee arthroplasty were randomised to control and treatment (ischaemic preconditioning) groups. Patients in the treatment group received a preconditioning stimulus immediately prior to surgery. The ischaemic preconditioning stimulus consisted of three five-minute periods of tourniquet insufflation on the lower operative limb, interrupted by five minute periods of reperfusion. All patients had a tourniquet applied to the lower limb after the administration of spinal anaesthesia, as per normal protocol for knee arthroplasty surgery. Muscle biopsies were taken from the quadriceps muscle of the operative knee at the immediate onset of surgery (T0) and at 1 hour into surgery (T1). Total RNA was extracted from biospies of four control and four treatment patients and hybridised to the Affymetrix Human U133 2.0 chip.
2010-04-12 | E-GEOD-21164 | biostudies-arrayexpress
Project description:AimsNearly 99,000 total knee arthroplasties (TKAs) are performed in UK annually. Despite plenty of research, the satisfaction rate of this surgery is around 80%. One of the important intraoperative factors affecting the outcome is alignment. The relationship between joint obliquity and functional outcomes is not well understood. Therefore, a study is required to investigate and compare the effects of two types of alignment (mechanical and kinematic) on functional outcomes and range of motion.MethodsThe aim of the study is to compare navigated kinematically aligned TKAs (KA TKAs) with navigated mechanically aligned TKA (MA TKA) in terms of function and ROM. We aim to recruit a total of 96 patients in the trial. The patients will be recruited from clinics of various consultants working in the trust after screening them for eligibility criteria and obtaining their informed consent to participate in this study. Randomization will be done prior to surgery by a software. The primary outcome measure will be the Knee injury and Osteoarthritis Outcome Score The secondary outcome measures include Oxford Knee Score, ROM, EuroQol five-dimension questionnaire, EuroQol visual analogue scale, 12-Item Short-Form Health Survey (SF-12), and Forgotten Joint Score. The scores will be calculated preoperatively and then at six weeks, six months, and one year after surgery. The scores will undergo a statistical analysis.DiscussionThere is no clear evidence on the best alignment for a knee arthroplasty. This randomized controlled trial will test the null hypothesis that navigated KA TKAs do not perform better than navigated MA TKAs. Cite this article: Bone Jt Open 2021;2(11):945-950.
| S-EPMC8636290 | biostudies-literature
Project description:BACKGROUND:The number of patients operated on for total knee arthroplasty (TKA) is growing worldwide. Outpatient surgery is defined by a length of stay (LOS) in the hospital of less than 12?h. This can be limited for TKA, with the efficient management of pain and perioperative complications, such as blood loss, affecting a safe hospital discharge. Outpatient TKA with a suitable protocol, including multimodal measures, could improve the success rate of this procedure. Among the main measures, single-shot sciatic nerve block in association with continuous femoral nerve block for pain control needs to be evaluated in outpatient TKA. Furthermore, to promote the safety of the postoperative period and to accelerate rehabilitation, patients who undergo ambulatory TKA could be discharged to a rehabilitation center on the day of surgery to screen adverse events and to optimize the rehabilitation process. This study is designed to assess the benefits of sciatic nerve block in postoperative pain relief for outpatient TKA. METHODS/DESIGN:This randomized prospective controlled study will be conducted in the knee unit of the teaching hospital of the Nice university and will include 40 patients undergoing primary unilateral outpatient TKA, discharged the day of surgery to a private rehabilitation center for enhanced recovery after surgery, after a hospital stay of less than 12?h. Before surgery, all patients will receive a continuous femoral nerve block with 2?mg/ml ropivacaine 20?ml, and then patients will be randomly assigned to receive or not receive a single-shot sciatic nerve block with 2?mg/ml ropivacaine, 20?ml. The primary outcome measure is the success rate of outpatient TKA. This rate is defined by patients discharged from the hospital to a rehabilitation center the day of surgery with no re-hospitalization due to insufficient pain control before the fifth postoperative day. Secondary outcomes include the incidence of major and minor adverse events during the first five postoperative days and measurement of the quality of recovery using the Knee injury and Osteoarthritis Outcome Score and the new International Knee Society scores plus the Quality of Recovery-40 questionnaire. DISCUSSION:The assessment of anesthesia and rehabilitation protocols enabling major orthopedic surgery, such as TKA, is necessary. This randomized controlled study will address the hypothesis that a suitable multimodal protocol including sciatic nerve block could improve pain control and thus improve the success rate of outpatient TKA. TRIAL REGISTRATION:EudraCT, 2016-000226-19. Registered on 15 April 2016.
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Project description:BACKGROUND:Due to shorter hospitalization, patients have to take responsibility for their rehabilitation period at a very early stage. The objective of this trial is to study the effects of two treatment schemes following total knee arthroplasty: conventional treatment following discharge from hospital and early follow-up by telephone consultations in addition to conventional treatment following discharge from hospital. The ultimate aim is to increase the effectiveness of the treatment by improving patients' health status, promote self-efficacy, and reduce the number of acute visits to the orthopaedic outpatient clinic during the rehabilitation period. METHOD/DESIGN:The design is a randomized un-blinded parallel group clinical trial conducted at the Department of Orthopaedic Surgery, Gentofte Hospital, the Capital Region of Denmark. In total, 116 patients will be allocated by an external randomization program to 2 groups: an intervention group following usual treatment after discharge supplemented by a nurse managed structured follow-up consultation conducted by telephone 4 and 14 days after discharge from hospital and a control group following treatment as usual. The consultations are structured by key subjects relevant to assess the health status according to the VIPS-model (the Swedish acronym for the concepts Well-being, Integrity, Prevention and Safety). The content of the consultations can vary according to the patients´ individual situations and needs. All consultations are conducted by the researcher responsible for the trial. The effect is measured 1, 3, 6 and 12 months post-surgery. The primary outcome is self-reported physical function measured by The Western Ontario and McMaster Universities Arthritis Index. Secondary outcomes are self-reported health-related quality of life, general self-efficacy and the number of acute visits to the orthopaedic outpatient clinic. DISCUSSION:The result of this trial is expected to provide new knowledge to support the development of targeted and effective follow-up after total knee arthroplasty in order to improve the patients´ health-related knowledge and skills of being able to take actively part in their illness and improve their health status. TRIAL REGISTRATION:ClinicalTrials.gov: NCT01771315.
| S-EPMC4035798 | biostudies-literature
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:The effect of patient education before total knee arthroplasty (TKA) is controversial. No consensus exists about the optimal content of educational interventions. In a previous study, we developed and validated an educational booklet on the peri-TKA management of knee osteoarthritis.Our primary purpose was to evaluate the impact of the educational booklet on knowledge among patients awaiting TKA.This randomized controlled single-blind trial evaluated standard information by the surgeon with or without delivery of the educational booklet 4-6 weeks before primary noncomplex TKA in patients aged 55-75 years with incapacitating knee osteoarthritis. Patients were enrolled at a French surgical center between June 2011 and January 2012. A patient knowledge score was determined at baseline, on the day before TKA, and 3-6 weeks after TKA, using a self-administered questionnaire developed for our previous study. The assessor was blinded to group assignment.Of 44 eligible patients, 42 were randomized, 22 to the intervention and 20 to the control group, all of whom were included in the analysis. The groups were comparable at baseline. The intervention was associated with significantly better patient knowledge scores.An educational booklet improves knowledge among patients awaiting TKA. A study assessing the impact of the booklet combined with a exercise program would be helpful.Level I, randomized controlled double-blind trial; see S1 CONSORT Checklist.clinicaltrials.gov #NCT01747759.
| S-EPMC5497941 | biostudies-literature
Project description:ObjectiveTo establish the efficacy of motivational interviewing-based postoperative care navigation in improving functional status after total knee arthroplasty (TKA) and to identify subgroups likely to benefit from the intervention.MethodsWe conducted a parallel randomized controlled trial in TKA recipients with 2 arms: postoperative care with frequent followup by a care navigator or usual care. The primary outcome was the difference between the arms in Western Ontario and McMaster Universities Osteoarthritis Index function score change, over 6 months postsurgery. We performed a preplanned subgroup analysis of differential efficacy by obesity and exploratory subgroup analyses on sex and pain catastrophizing.ResultsWe enrolled 308 subjects undergoing TKA for osteoarthritis. Mean ± SD preoperative function score was 41 ± 17 (0-100 scale, where 100 = worst function). At 6 months, subjects in the navigation arm improved by mean ± SD 30 ± 16 points compared to 27 ± 18 points in the usual-care arm (P = 0.148). Participants with moderate to high levels of pain catastrophizing were unlikely to benefit from navigation compared to those with lower levels of pain catastrophizing (P = 0.013 for interaction).ConclusionSubjects assigned to the navigation intervention did not demonstrate greater functional improvement compared to those in the control group. The negative overall result could be explained by the large effect on functional improvement of TKA itself compared to the smaller, additional benefit from care navigation, as well as by potential differential effects for subjects with moderate to high degrees of pain catastrophizing. Greater focus on developing programs for reducing pain catastrophizing could lead to better functional outcomes following TKA.
| S-EPMC5480617 | biostudies-literature