grant

Swelling Management after Total Knee Arthroplasty

Organization UNIVERSITY OF COLORADO DENVERLocation Aurora, UNITED STATESPosted 2 Aug 2023Deadline 30 Jun 2027
NIHUS FederalResearch GrantFY2025AcuteAddressArticular Range of MotionAtrophicAtrophyClinicalClinical TrialsCohort StudiesCompression StockingConcurrent StudiesDeep Vein ThrombosisDeep-Venous ThrombosisDegenerative ArthritisDegenerative polyarthritisEffectivenessElasticityEquilibriumExtremitiesGait speedHealthIndividualInfectionInterventionJoint Range of MotionJointsKneeKnee OsteoarthritisKnee arthroplastyKnee joint replacement operationKnee replacementLaboratoriesLimb structureLimbsMediatingMedical RehabilitationNon-TrunkOperative ProceduresOperative Surgical ProceduresOsteoarthritisOsteoarthrosisOutcomePainPainfulParticipantPathway interactionsPatient Outcomes AssessmentsPatient Reported MeasuresPatient Reported OutcomesPerformancePhysical FunctionPositionPositioning AttributePostoperativePostoperative PeriodRecommendationRehabilitationRehabilitation therapyResearchRoleSample SizeStandardizationSurgicalSurgical InterventionsSurgical ProcedureSwellingTestingThromboembolismTotal Knee ReplacementTraumaWOMACWestern Ontario and McMaster Universities Arthritis IndexWestern Ontario and McMaster Universities Osteoarthritisattenuationbalancebalance functioncompare to controlcomparison controlcost effective interventiondecline in functiondecline in functional statusdegenerative joint diseasedesigndesigningdisabilityfall riskfunctional declinefunctional lossfunctional outcomesfunctional status declinehypertrophic arthritisimprovedin vivoinsightknee OAknee joint OAknee joint osteoarthritisknee replacement arthroplastylater in lifelater lifeolder adultolder adulthoodpain reductionpathwaypatient populationpreventpreventingprimary end pointprimary endpointprimary outcomeprogramsquadricepsquadriceps musclerandomized control studyrandomized, controlled studyrange of motionreduce painrehab therapyrehabilitativerehabilitative therapysocial rolestandard of caresurgerytheoriestotal knee arthroplasty
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Full Description

PROJECT SUMMARY
Although total knee arthroplasty (TKA) is effective at reducing pain from end-stage osteoarthritis (OA), it is

an acute trauma to the joint which exacerbates the underlying weakness and disability common with OA,

leading to long-term atrophy and further disability. Attenuation of this acute loss of strength and function can

lead to improved long-term outcomes. Key to attenuating this acute loss is effectively managing postoperative

knee swelling. Knee swelling after TKA is profound and is theorized to be a major driver of this acute strength

and functional loss. This early postoperative strength loss is driven by a deficit in voluntary activation that

acutely limits rehabilitation potential and leads to long-term atrophy and disability. Traditional interventions

such as elastic compression stockings (e.g., thromboembolism-deterrent [TED] hose) have minimal

effectiveness in reducing swelling after TKA. We have demonstrated in a preliminary study that an inelastic,

adjustable compression garment can decrease early postoperative swelling by 50%. However, there is a need

to formally evaluate the preliminary effects of this garment on all outcomes to inform sample size calculations

for a larger trial. Additionally, as a majority of research to date on quadriceps activation and swelling has relied

on laboratory induced swelling, this trial will be uniquely positioned to explore in-vivo mechanistic relationships

between changes in swelling and quadriceps activation. Therefore, we propose a randomized controlled study

of 58 older adult participants undergoing TKA to determine if an inelastic adjustable compression garment

(INCOM) improves postoperative swelling more than elastic TED hose (CONTROL). Both groups will wear the

assigned garments for the first 3 weeks after TKA and participate in a standardized rehabilitation program after

TKA. Outcomes will be assessed preoperatively and postoperatively at weeks 1, 3 (end of garment use),12

and 26. This study will enable us to determine (AIM 1) if INCOM results in improved surgical limb swelling

control after TKA (primary outcome) compared to CONTROL and (AIM 2) to explore the preliminary efficacy of

INCOM on the outcomes of quadriceps strength, pain, range of motion, physical function, and patient reported

outcomes after TKA compared to CONTROL. Additionally, we will explore (EXPLORATORY AIM) the

mediating role of swelling on outcomes after TKA. This study has high potential to prevent acute strength and

functional losses in the short-term and improve long-term health of the millions of older adults who will undergo

TKA annually. This study will uniquely provide insights into 1) causal relationships between swelling and

strength/functional outcomes and 2) mechanisms for quadriceps activation deficits. Study findings will also

provide insights into the management of numerous other patient populations with significant quadriceps

activation deficits (knee OA) or extremity swelling (post-surgical or trauma).

Grant Number: 5R21AR082101-03
NIH Institute/Center: NIH

Principal Investigator: Michael Bade

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