[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595461":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":54,"locations":60,"responsibleParty":78,"collaborators":81,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":41,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":41,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":112,"overallStatus":114,"whyStopped":41,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Shirley Ryan AbilityLab","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"OPRA implant system","ACTIVE_COMPARATOR","OPRA implant with surface EMG and myoelectric prosthesis system.",[13],"Device: OPRA",{"label":15,"type":16,"description":17,"interventionNames":18},"eOPRA implant system","EXPERIMENTAL","eOPRA system with implanted EMG control and myoelectric prosthesis system.",[19],"Device: eOPRA",{"label":21,"type":10,"description":22,"interventionNames":23},"eOPRA system without sensory feedback","eOPRA implant system without sensory feedback and myoelectric prosthesis system.",[24],"Device: eOPRA without sensory feedback",{"label":26,"type":16,"description":27,"interventionNames":28},"eOPRA system with sensory feedback","eOPRA implant system with sensory feedback and myoelectric prosthesis system.",[29],"Device: eOPRA with sensory feedback",[31,38,42,46],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","eOPRA","Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system for transhumeral amputees.",[15],[37],"OPRA",{"type":32,"name":37,"description":39,"armGroupLabels":40,"otherNames":41},"Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations",[9],null,{"type":32,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"eOPRA with sensory feedback","Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations with sensory feedback.",[26],{"type":32,"name":47,"description":48,"armGroupLabels":49,"otherNames":41},"eOPRA without sensory feedback","Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations without sensory feedback.",[21],[51],{"name":52,"affiliation":5,"role":53},"Levi Hargrove, PhD","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":41,"email":59},"Suzanne B Finucane, MS","CONTACT","312-238-0937","sfinucane@sralab.org",[61],{"facility":62,"status":41,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Shirley Ryan Abilitylab","Chicago","Illinois","60611","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-87.65005,41.85003,{"lat":72,"lon":71},[75,77],{"name":76,"role":57,"phone":58,"phoneExt":41,"email":59},"Suzanne Finucane, MS",{"name":52,"role":53,"phone":41,"phoneExt":41,"email":41},{"type":53,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Levi Hargrove","Scientific Chair, Center for Bionic Medicine, Shirley Ryan Abilitylab",[82,85,87],{"name":83,"class":84},"Integrum","INDUSTRY",{"name":86,"class":6},"Northwestern Memorial Hospital",{"name":88,"class":89},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100595461","neuromusculoskeletal-interface-for-bionic-arms-100595461",false,"NCT07032753","Neuromusculoskeletal Interface for Bionic Arms","Neuromusculoskeletal Interface for Bionic Arms: A Randomized Crossover Study","Inclusion Criteria:\n\n* Between the ages of 18 and 70 years old\n* Unilateral transhumeral level absence\n* Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes).\n* Candidate for TMR surgery as verified by surgical team\n* Candidate for OPRA surgery as verified by surgical team\n* English speaking\n\nExclusion Criteria:\n\n* Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.\n* Cognitive impairment sufficient to adversely affect understanding of, or compliance with, study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate usable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study. These cognitive impairments would be confirmed with the Mini-Mental State exam.\n* Proximal nerve injury that would prevent TMR or sensory feedback\n* Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers. Examples include: injuries to the shoulder, cervical spine or sound side joint pain that would prohibit the participants from being able use a prosthesis. Medical conditions including unregulated high blood pressure or advanced heart disease that would exclude the participant as an appropriate surgical candidate.\n* Individuals who smoke. This may interfere with the OPRA process from both bone healing and soft tissue standpoints.\n* Individuals with active implants. This has been a restriction of prior FDA IDE to investigate e-OPRA.\n* Pregnant women\n* Non-English speaking","ALL","18 Years","70 Years",{"count":101,"type":102},12,"ESTIMATED","INTERVENTIONAL",[105],"NA","The overall objective of this proposal is to perform a first-in-human home trial of the Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations who have had Targeted Muscle Reinnervation (TMR) surgery and use a pattern recognition-controlled myoelectric prosthesis. The purpose of the study is to capture preliminary safety and effectiveness information on the e-OPRA device when used with the prosthetic systems. The investigators expect that the e-OPRA implant system will be safe and provide clinically and statistically significant improvements in control and comfort.\n\nSpecifically, the investigators hypothesize that the e-OPRA system will (1) allow for training of more functional prosthesis controllers, (2) provide more stable electromyographic (EMG) signals, reducing the need to recalibrate the prosthetic control system, and (3) be more comfortable, as it does not require a tethered arm-band to record surface EMG signals.\n\nPhase 1: Perform TMR and e-OPRA surgeries in 8 persons with transhumeral amputations.\n\nPhase 2: Perform a randomized cross-over study to compare the OPRA and e-OPRA system (without sensory feedback) in 8 transhumeral amputees who have received TMR.\n\nPhase 3: Perform a randomized cross-over study to compare the e-OPRA system with and without sensory feedback in 8 transhumeral amputees who have received TMR.",[108,109,110,111],"Amputation","Amputation, Traumatic","Amputation, Surgical","Upper Limb Amputation Above Elbow (Injury)",[113],"eOPRA for transhumeral amputees","NOT_YET_RECRUITING","2025-06-12",{"date":117,"type":118},"2025-06-24","ACTUAL",{"date":120,"type":102},"2026-01-01",{"date":122,"type":102},"2029-05-31",{"name":5,"class":6},1]