{ "FullStudy":{ "Rank":217672, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518335", "OrgStudyIdInfo":{ "OrgStudyId":"HN4157" }, "Organization":{ "OrgFullName":"Albert Einstein Healthcare Network", "OrgClass":"OTHER" }, "BriefTitle":"Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department", "OfficialTitle":"A Double-Blind, Randomized, Placebo Controlled Study Evaluating the Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department.", "Acronym":"PRP" }, "StatusModule":{ "StatusVerifiedDate":"May 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2009" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 8, 2011", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 8, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 10, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"James Gardner, MD", "ResponsiblePartyInvestigatorTitle":"MD", "ResponsiblePartyInvestigatorAffiliation":"Albert Einstein Healthcare Network" }, "LeadSponsor":{ "LeadSponsorName":"Albert Einstein Healthcare Network", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This research study hopes to determine whether or not platelet rich plasma therapy improves healing time of moderate to severe ankle sprain in comparison to standard of care therapy.", "DetailedDescription":"The intention of this research project is to study a new treatment for severe ankle sprains.This new treatment is called Platelet Rich Plasma (PRP) therapy and involves injecting concentrated platelet's from a patient's own blood into the site of injury to aid healing. Platelets, aside from their clotting capabilities also serve a role in re-vascularization of tissue as well as collagen repair. PRP therapy has been used in sports medicine for treatment of chronic injuries but has yet to be proven effective in acute injury of a joint. The investigators are comparing treatment and placebo groups based on a subjective patient questionnaire and pain score administered on the day of injury and 2-3 days and 8-10 days follow up." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Sprain of Ankle" ] }, "KeywordList":{ "Keyword":[ "platelet rich plasma", "ankle", "sprain", "injection", "Platelet Rich Plasma therapy", "focal, invasive therapy for sprains" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"38", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Platelet Rich Plasma", "ArmGroupType":"Experimental", "ArmGroupDescription":"Patients receive Platelet rich plasma injection + standard of care therapy(bandaging or boot and crutches) + non-NSAID pain medicine", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Platelet rich plasma injection" ] } },{ "ArmGroupLabel":"Placebo/Standard of Care", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Patient receives Placebo Comparator: Placebo/Standard of Care [saline injection + standard of care (bandaging or boot and crutches)] + non-NSAID pain medicine", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Placebo Comparator: Placebo/Standard of Care" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"Platelet rich plasma injection", "InterventionDescription":"50ml of blood drawn into a 60cc with 10cc of anticoagulant is processed using MAGELLAN® Autologous Platelet (Arteriocyte Medical Systems, Cleveland Ohio)to separate out approximately 3-6 cc of platelet rich plasma, which is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Platelet Rich Plasma" ] } },{ "InterventionType":"Procedure", "InterventionName":"Placebo Comparator: Placebo/Standard of Care", "InterventionDescription":"50ml of blood is drawn into a 60cc with 10cc of anticoagulant and is then discarded. 4 cc of saline solution is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo/Standard of Care" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function.", "PrimaryOutcomeDescription":"The primary outcome of this investigation is change from baseline in LEFS score, a previous validated 80-point scale used to quantify lower extremity function. A difference of 9 points is considered clinically significant.", "PrimaryOutcomeTimeFrame":"Day 0; Day2-3; Day 8-10; Day30" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in pain from baseline", "SecondaryOutcomeDescription":"Changes in level of pain from baseline was measured using VAS scale as well as comparing need for narcotics use at each follow up time point.", "SecondaryOutcomeTimeFrame":"Day 0; Day 2-3, Day 8-10, Day 30" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nsevere ankle sprain\nX-ray completed\n\nExclusion Criteria:\n\nPregnancy/breastfeeding\nPolice custody\nactive infection\nmetastatic disease/tumors\nHistory of thrombocytopenia\nAllergy to ester or amine anesthetics\nOn anticoagulant medication\nPeripheral vascular disease\nKnown coagulopathy", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Adam Rowden, DO", "OverallOfficialAffiliation":"Eisntein Healthcare Network", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Einstein Healthcare Network", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19141", "LocationCountry":"United States" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000004630", "ConditionMeshTerm":"Emergencies" },{ "ConditionMeshId":"D000013180", "ConditionMeshTerm":"Sprains and Strains" },{ "ConditionMeshId":"D000016512", "ConditionMeshTerm":"Ankle Injuries" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000020969", "ConditionAncestorTerm":"Disease Attributes" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000014947", "ConditionAncestorTerm":"Wounds and Injuries" },{ "ConditionAncestorId":"D000007869", "ConditionAncestorTerm":"Leg Injuries" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M6379", "ConditionBrowseLeafName":"Emergencies", "ConditionBrowseLeafAsFound":"Emergency", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14557", "ConditionBrowseLeafName":"Sprains and Strains", "ConditionBrowseLeafAsFound":"Sprain", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M17492", "ConditionBrowseLeafName":"Ankle Injuries", "ConditionBrowseLeafAsFound":"Ankle Sprain", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M21284", "ConditionBrowseLeafName":"Disease Attributes", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16268", "ConditionBrowseLeafName":"Wounds and Injuries", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9464", "ConditionBrowseLeafName":"Leg Injuries", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC26", "ConditionBrowseBranchName":"Wounds and Injuries" } ] } } } } } }