Comprehensive SRS Regenerex Tissue Attachment

Launched by ZIMMER BIOMET · Sep 23, 2024

Nctid: NCT06615739

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010003", "term"=>"Osteoarthritis"}], "ancestors"=>[{"id"=>"D000001168", "term"=>"Arthritis"}, {"id"=>"D000007592", "term"=>"Joint Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000012216", "term"=>"Rheumatic Diseases"}], "browseLeaves"=>[{"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M12926", "name"=>"Osteoarthritis", "asFound"=>"Osteo Arthritis", "relevance"=>"HIGH"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"OTHER", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>103}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-18", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Kaplan Meier Implant Survivorship", "timeFrame"=>"Up to 10 Years", "description"=>"This will be established by recording the incidence and frequency of device revisions. Kaplan-Meier survival analysis is a statistical method that estimates survival rates over time and accounts for factors that can affect implant survival."}, {"measure"=>"Safety Assessement", "timeFrame"=>"Up to 10 Years", "description"=>"This will be established by recording the incidence and frequency of complications and adverse events. Relation of the events to the implant and/or procedure will be specified."}], "secondaryOutcomes"=>[{"measure"=>"Assessment of performance and clinical benefits by recording patient reported QuickDASH", "timeFrame"=>"Up to 10 Years", "description"=>"QuickDASH, or Quick Disabilities of the Arm, Shoulder, and Hand, is a questionnaire that measures the impact of upper limb musculoskeletal disorders on physical function and symptoms.\n\nThe QuickDASH has 11 items that cover six domains:\n\nDaily activities: How much difficulty the patient has performing physical activities Symptoms: How severe the patient\\'s pain and tingling is Social function: How the patient\\'s problem affects their social activities Work function: How the patient\\'s problem affects their work Sleep: How the patient\\'s problem affects their sleep Confidence: How the patient\\'s problem affects their confidence\n\nEach item is rated on a 5-point Likert scale, with 1 being no difficulty and 5 being unable. The score is then converted to a 100-point scale, with 100 representing the greatest disability."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Medical Device", "Safety", "Performance"], "conditions"=>["Arthroplasty Complications", "Osteo Arthritis Shoulders"]}, "descriptionModule"=>{"briefSummary"=>"The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb salvage arthroplasty.", "detailedDescription"=>"Consecutive subjects implanted with Comprehensive SRS Regenerex Tissue Attachment Augments according to the approved indications, with the longest-term follow-up possible, willl be identified and invited to participate in the study.\n\nThe primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to the implant and/or procedure should be specified.\n\nThe study will include one site. There will be a maximum of 103 patients enrolled in the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Subjects must meet the inclusion criteria to be enrolled into the study. Subjects who meet any of the exclusion criteria should not be enrolled into the study.\n\nThe study population will comprise a consecutive cohort of up to 103 subjects implanted using the Comprehensive SRS Regenerex Tissue Attachment Augments.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patient must be 18 years of age or older.\n* Patient must be willing and able to follow directions.\n* The Comprehensive Segmental Revision System was used in cases of:\n\n 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.\n 2. Revision where other devices or treatments have failed.\n 3. Correction of functional deformity.\n 4. Oncology applications including bone loss due to tumor resection.\n* Proximal or total humeral replacement, for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.\n* Distal or total humeral replacement for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.\n* Biomet Comprehensive Segmental Revision System was used in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff for proximal humeral replacement. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.\n* The Comprehensive Segmental Revision System was used with bone cement in distal humeral and total humeral applications.\n* Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision System\n\nExclusion Criteria:\n\n* Absolute contraindications:\n\n * Infection\n * Sepsis\n * Osteomyelitis\n * Patient is a prisoner\n * Patient is a current alcohol or drug abuser\n * Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent\n * Patient is unwilling to consent\n* Relative contraindications:\n\n * Uncooperative patient or patient with neurologic disorders who is incapable of following directions\n * Osteoporosis\n * Metabolic disorders which may impair bone formation\n * Osteomalacia\n * Distant foci of infections which may spread to the implant site\n * Vascular insufficiency, muscular atrophy, or neuromuscular disease\n* The Comprehensive Segmental Revision System was used in a reverse shoulder application in patients receiving radiation therapy\n* The Comprehensive Segmental Revision System was used without bone cement in distal humeral and total humeral applications.\n* Regenerex Tissue Attachment Augments weren't used during the patient's surgery"}, "identificationModule"=>{"nctId"=>"NCT06615739", "briefTitle"=>"Comprehensive SRS Regenerex Tissue Attachment", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Zimmer Biomet"}, "officialTitle"=>"Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Segmental Revision System (SRS) Regenerex Tissue Attachment Augments - a Retrospective Enrollment and Prospective Follow-up Consecutive Series Study", "orgStudyIdInfo"=>{"id"=>"CMU2024-12E"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Comprehensive Regenerex Tissue Attachment Augments", "description"=>"Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision system", "interventionNames"=>["Device: Regenerex Tissue Attachment Augments"]}], "interventions"=>[{"name"=>"Regenerex Tissue Attachment Augments", "type"=>"DEVICE", "description"=>"Patient will have been previously implanted with Regenerex Tissue Attachment Augments in combination with the Comprehensive Segmental Revision System", "armGroupLabels"=>["Comprehensive Regenerex Tissue Attachment Augments"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33432", "city"=>"Boca Raton", "state"=>"Florida", "country"=>"United States", "contacts"=>[{"name"=>"Chuck V Toman, MD", "role"=>"CONTACT", "email"=>"chuck@chucktoman.com", "phone"=>"561-221-6895"}, {"name"=>"Charles V Toman, MD", "role"=>"CONTACT"}], "facility"=>"Toman Orthopedics and Sports Med", "geoPoint"=>{"lat"=>26.3669, "lon"=>-80.13033}}], "centralContacts"=>[{"name"=>"Cayla J LaFollette, BS", "role"=>"CONTACT", "email"=>"cayla.lafollette@zimmerbiomet.com", "phone"=>"574-268-8610"}, {"name"=>"Ryan Boylan", "role"=>"CONTACT", "email"=>"ryan.boylan@zimmerbiomet.com"}], "overallOfficials"=>[{"name"=>"Erin Osborn", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Zimmer Biomet"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>"IPD may not be shared due to this being a single center retrospective enrollment/prospective FUP with one single reference point. Additionally, data is being collected for EU regulatory purposes."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Zimmer Biomet", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}