[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amputation-traumatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amputation-traumatic":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,74,105,138,173,200,238],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100167904","phase-2-human-upper-extremity-allotransplantation-100167904",false,"NCT01459107","Human Upper Extremity Allotransplantation","Recipient Inclusion Criteria:\n\n* Recent (≥6 months) or remote (i.e., several decades) unilateral or bilateral upper limb loss (below the shoulder) desiring limb transplantation.\n* Below-shoulder amputation.\n* Functionless or minimally functional hand desiring removal of functionless \u002F minimally functional hand followed by transplantation.\n* Male or female and of any race, color or ethnicity.\n* Aged 18-69 years.\n* Completes the protocol informed consent form.\n* No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (see Donor and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of upper extremity transplantation.)\n* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).\n* Negative for malignancy for past 5 years.\n* Negative for HIV at transplant.\n* Negative crossmatch with donor.\n* If female of child-bearing potential, negative serum pregnancy test.\n* If female of child-bearing potential, consent to use reliable contraception for at least one year following transplantation.\n* Consents to bone marrow infusion as part of the treatment regime.\n* USA citizen or equivalent, or foreigner with documentation of ability to pay for transplant and required follow-up care.\n* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.\n\nDonor Inclusion Criteria:\n\nDonors will be selected by the upper extremity transplant team in conjunction with the organ procurement organization (OPO) according to the following criteria:\n\n* Brain dead meeting the criteria for Determination of Death.\n* Family consent for limb donation.\n* Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure).\n* Aged 16 - 65 years.\n* Limb matched for size with recipient.\n* Same blood type as recipient.\n* Negative lymphocytotoxic crossmatch.\n* Accurately matched for gender, skin tone, and race (relative requirements depending on recipient consent).\n\nExclusion Criteria:\n\n• Positive for any of the following conditions:\n\n* Untreated sepsis.\n* HIV (active or seropositive).\n* Active tuberculosis.\n* Hepatitis B or C.\n* Viral encephalitis.\n* Toxoplasmosis.\n* Malignancy (within past 5 years).\n* Current\u002Frecent (within 3 months of donation\u002Fscreening consent) IV drug abuse.\n* Paralysis of ischemic or traumatic origin.\n* Inherited peripheral neuropathy.\n* Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.\n* Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).\n* Mixed connective tissue disease.\n* Severe deforming rheumatoid or osteoarthritis in the limb.\n\nDonor Only:\n\n• Tattoos:\n\n* Non-professional tattoo within last 6 months, or\n* Personally identifiable tattoo (i.e., donor name) on potential transplant.\n\nRecipient Only:\n\n* Type I (insulin-dependent) diabetes mellitus\n* Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.\n* Sensitized recipients with high levels (50%) of panel-reactive human leukocyte antigen (HLA) antibodies.\n* Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.\n* Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery.\n* Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like osteopetrosis.\n* Patients considered unsuitable per the consulted Psychiatrists appraisal.","ALL","18 Years","69 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background: Millions of people each year sustain injuries, have tumors surgically removed, or are born with defects that require complex reconstructive surgeries to repair. In the case of hand, forearm, or arm amputation, prostheses only provide less than optimal motor function and no sensory feedback. However, hand and arm transplantation is a means to restore the appearance, anatomy, and function of a native hand. Although over 70 hand transplants have been performed to date and good functional results have been achieved, widespread clinical use has been limited due to adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential benefits of hand transplantation.\n\nStudy Design: This non-randomized, Phase II clinical trial will document the use of a new immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing hand transplantation as a safe and effective reconstructive treatment for upper extremity amputations by minimizing maintenance immunosuppression therapy in unilateral and bilateral hand\u002Fforearm transplant patients. This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled graft survival using low doses of a single immunosuppressive drug followed by weaning of treatment. Initially designed for living-related solid organ donation, this regimen has been adapted for use with grafts donated by deceased donors. The investigators propose to perform 30 human hand transplants employing this novel protocol.\n\nSpecific Aims: 1) To establish hand transplantation as a safe and effective reconstructive strategy for the treatment of upper extremity amputations; 2) To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long-term high dose multi-drug immunosuppression.\n\nSignificance of Research: Hand transplantation could help upper extremity amputees recover functionality, self-esteem, and the capability to reintegrate into family and social life as \"whole\" individuals. The protocol offers the potential for minimizing the morbidity of maintenance immunosuppression, thereby beneficially shifting the risk\u002Fbenefit ratio of this life-enhancing procedure and enabling widespread clinical application of hand transplantation.",[26,27,28],"Amputation, Traumatic","Wounds and Injuries","Hand Injuries",[30,31,32,33,34,35,36],"Hand Transplant","Composite Tissue Allotransplantation (CTA)","Vascularized Composite Allotransplantation (VCA)","Composite Tissue","Amputation","Upper limb","Immunosuppression","RECRUITING","2026-05-11",{"date":40,"type":41},"2026-05-12","ACTUAL",{"date":43,"type":41},"2011-07-21",{"date":45,"type":20},"2036-06-30",{"name":47,"class":48},"Johns Hopkins University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":49},"100316497","human-upper-extremity-allotransplantation-fu-protocol-100316497","NCT03400345","Human Upper Extremity Allotransplantation: F\u002FU Protocol","Human Upper Extremity Allotransplantation: Transplanted Patient Follow-Up Protocol","Inclusion Criteria:\n\n* Males and females 5 or more years post-unilateral or bilateral upper limb transplantation.\n* Completes the protocol informed consent form.\n* Consents to sample collection and storage (biopsies).\n* USA citizen or equivalent.\n* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.\n\nExclusion Criteria:\n\n* Candidate has not received an upper extremity allotransplant.\n* Any reason the study team thinks would cause the participant to be noncompliant or would put the patient at unacceptable risk if enrolled.","100 Years",{"count":59,"type":20},60,"OBSERVATIONAL","Upper extremity allotransplantation is a new procedure which is becoming more common in the United States. Ongoing data collection for research purposes is vital to the long-term assessment as to the safety of the procedure and accompanying immunosuppression protocol, as well as quantifying patient outcomes and changes in quality of life. For these reasons, The Johns Hopkins Hand\u002FArm Transplantation Team is interested in enrolling transplanted patients in a follow-up protocol to continue collecting informative data to further the field of vascularized composite allotransplantation.",[26,63,28],"Wounds and Injury",[30,65,32,34,66,36],"composite tissue allograft (CTA)","Upper Limb","2026-05-07",{"date":38,"type":41},{"date":70,"type":41},"2017-07-25",{"date":72,"type":20},"2036-07-30",{"name":47,"class":48},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":49},"100606447","operative-treatment-vs-treatment-with-semi-occlusive-dressing-for-single-finger-amputations-100606447","NCT07175675","Operative Treatment vs Treatment With Semi-occlusive Dressing for Single Finger Amputations","Operative Treatment vs Treatment With Semi-occlusive Dressing - a Randomized, Controlled Trial on Finger Amputations","FINACT","Inclusion Criteria:\n\n* age \\>18, single digit injury, Amputation at Tamai zones 1+2 in all digits or Tamai zones 3+4 in digits II-V, Able to understand Finnish and to complete self-reported questionnaires\n\nExclusion Criteria:\n\n* Previous partial or total amputation of the injured digit, Previous condition which affects significantly the function and\u002For symptoms of the affected hand, Patient is pregnant at the time of recruitment",{"count":83,"type":20},252,[85],"NA","The goal of this interventional study is to find out whether conservative treatment with semi-occlusive film is superior to surgical treatment in single finger amputations in adult population. The main question it aims to answer is:\n\nIs PRWHE (Patient Reported Wrist and Hand Evaluation) total score measured at 12 months after injury better in conservatively or operatively treated patients?",[88,89,90,91,26,34],"Fingertips Traumatic Amputations","Finger Injuries","Finger","Finger Injury",[93,94,95],"finger amputation","single finger amputation","single digit amputation","2025-11-17",{"date":98,"type":41},"2025-11-21",{"date":100,"type":41},"2025-10-27",{"date":102,"type":20},"2032-01",{"name":104,"class":48},"Tampere University Hospital",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":121,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":137},"100593821","effects-of-myoelectric-channel-count-and-targeting-for-upper-limb-prosthetic-control-100593821","NCT07011420","Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control","Evaluation of Functional Performance of Persons With Limb Differences to Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis","Inclusion Criteria:\n\n* Unilateral transradial level limb absence\n* Current or past user of myo-electric controlled prostheses\n* Six months or more post-amputation\n* Have adequate limb length such that a wrist rotation device can fit in the check socket\n* Well-fitting socket as determined by a Socket-Comfort Score of 6 or above\n* Capable of wearing and operating a prosthesis with a wrist rotator and multi-articulating hand\n* Capable of understanding and following multi-step instructions and completing the tasks as described\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 for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.",{"count":113,"type":20},32,[85],"The goal of this clinical trial is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control translates to functional performance when tested on individuals aged 18 years or older with upper limb absence at the transradial level while wearing a physical prosthesis.\n\nThe specific aims of this study are:\n\n1. To evaluate the effect of changing untargeted myoelectric channel count on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test.\n2. To evaluate the effect of changing myoelectric channel targeting of a fixed number of myoelectric channels on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test.\n\nResearchers will perform a randomized crossover study to compare system configurations with different number of sensor channels and with various strategies for sensor placement on the limb. Participants will be assigned to a random test sequence that includes the following four different EMG channel conditions:\n\nCondition A: 4 untargeted channels Condition B: 8 untargeted channels Condition C: Up to 16 untargeted channels Condition D: 8 targeted channels\n\nResearchers will evaluate the effects of changing myoelectric channel counts on the functional prosthesis performance of individuals with transradial limb loss via functional outcome measures.\n\nParticipants will:\n\n* Attend up to 5 in-lab sessions that are expected to last 4 hours.\n* Conduct site visits every 1-2 weeks to complete functional and self reported outcome measures with each condition.\n* Play virtual games with the Coapt Cuff for 15 minutes a day, 3 days a week in between visits.",[34,26,117,118,119,120],"Amputation, Congenital","Prosthesis User","Upper Limb Amputation Below Elbow (Injury)","Amputation; Traumatic, Arm: Forearm, Between Elbow and Wrist",[122,123,124,125,126],"amputee","upper limb amputee","transradial amputee","prosthetic arm","upper limb prosthesis user","2025-09-02",{"date":129,"type":41},"2025-09-03",{"date":131,"type":20},"2025-10",{"date":133,"type":20},"2026-06",{"name":135,"class":136},"Liberating Technologies, Inc.","INDUSTRY",2,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":144,"minAge":16,"maxAge":17,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":148,"conditions":149,"keywords":156,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":49},"100239468","phase-2-human-penile-allotransplantation-100239468","NCT02395497","Human Penile Allotransplantation","Donor Inclusion Criteria:\n\n* Males aged 16 - 65 years.\n* Brain dead meeting the criteria for Determination of Death.\n* Family consent for penile graft donation.\n* Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure).\n* Same blood type as recipient.\n* Negative lymphocytotoxic crossmatch.\n* Accurately matched for skin tone\n\nRecipient Inclusion Criteria:\n\n* Males of any race, color or ethnicity; aged 18-69 years.\n* Recent (≥6 months) or remote (i.e., several decades) penile injury resulting in the loss of ≥75% of the phallus.\n* Penectomy secondary to penile cancer\n* Penile Cancer Survivors \\> 5 years\n* Micropenis associated with congenital\u002Fbirth defect and severely ambiguous male genitalia\n* Must have completed a clinic appointment with one of the study surgeons to discuss all penile reconstructive options.\n* Completes the protocol informed consent form(s).\n* No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of penile transplantation.).\n* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).\n* Negative for malignancy for past 5 years.\n* Negative for HIV at transplant.\n* Negative crossmatch with donor.\n* Consents to sample (i.e., skin biopsy) collection and storage and bone marrow infusion as part of the treatment regimen.\n* USA citizen or equivalent.\n* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regimen.\n\nRecipient and Donor Exclusion Criteria:\n\n* Untreated sepsis.\n* HIV (active or seropositive).\n* Active tuberculosis.\n* Active Hepatitis B infection.\n* Hepatitis C.\n* Viral encephalitis.\n* Toxoplasmosis.\n* Malignancy (within past 5 years).\n* Current\u002Frecent (within 3 months of donation\u002Fscreening consent) IV drug abuse.\n* Paralysis of ischemic or traumatic origin.\n* Inherited peripheral neuropathy.\n* Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.\n* Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).\n* Mixed connective tissue disease.\n* Severe deforming rheumatoid or osteoarthritis in the limb.\n\nDonor Only Exclusion Criteria:\n\n* Evidence of active herpes simplex virus-2 (HSV-2) infection.\n* Tattoos: non-professional tattoo within the last 6 months, or personally identifiable tattoo (i.e., donor name) on potential transplant.\n\nRecipient Only Exclusion Criteria:\n\n* Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.\n* Sensitized recipients with high levels (50%) of panel-reactive human leukocyte antigen (HLA) antibodies.\n* Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.\n* Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration).\n* Patients considered psychologically\u002Fpsychiatrically unsuitable.","MALE",{"count":59,"type":20},[23,147],"PHASE3","Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction.\n\nThe investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace \"like with like,\" restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results.\n\nStudy Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing\u002Ffrequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.",[34,27,26,150,151,152,153,154,155],"Urologic Surgical Procedures, Male","Amputation, Traumatic\u002FSurgery","Penis\u002FTransplantation","Penis\u002FSurgery","Penis\u002FInjuries","Congenital Anomaly, Male Genitalia",[157,32,31,158,34,36,33,159,160,161,162,163,164],"Penile Transplant","Penis","Male","Humans","Allotransplantation","Micropenis","Severely Aambiguous Male Genitalia","congenital\u002Fbirth defect","2025-07-03",{"date":167,"type":41},"2025-07-07",{"date":169,"type":41},"2014-06",{"date":171,"type":20},"2039-06",{"name":47,"class":48},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":49},"100595461","neuromusculoskeletal-interface-for-bionic-arms-100595461","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","70 Years",{"count":182,"type":20},12,[85],"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.",[34,26,186,187],"Amputation, Surgical","Upper Limb Amputation Above Elbow (Injury)",[189],"eOPRA for transhumeral amputees","NOT_YET_RECRUITING","2025-06-12",{"date":193,"type":41},"2025-06-24",{"date":195,"type":20},"2026-01-01",{"date":197,"type":20},"2029-05-31",{"name":199,"class":48},"Shirley Ryan AbilityLab",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":210,"conditions":211,"keywords":218,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100562541","feasibility-of-using-an-app-for-managing-phantom-limb-pain-associated-with-combat-injury-in-ukraine-pamela-100562541","NCT06604507","Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Injury in Ukraine (PAMELA)","Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Amputation in Ukraine: a Quantitative & Qualitative Observational Trial in the 'Prevention and Management of Phantom Limb Pain' Project","PAMELA","Inclusion Criteria:\n\n* Amputee has given written informed consent for participation in the study.\n* Male or Female\n* Age - no restriction but adult\n* Have undergone amputation of one limb, upper or lower.\n\nExclusion Criteria:\n\nFor Graded Motor Imagery \u002F Mirror therapy Amputees with disorders such as post-traumatic stress disorders should perform mirror therapy only after initial assessment by the therapist carrying out the treatment, as the mirror image of two intact limbs might elicit memories associated with the trauma",{"count":209,"type":20},200,"In Ukraine, since the beginning of the full-scale war on February 24, 2022, a large number of individuals have lost a limb(s). Many of these amputees cannot access appropriate care in terms of pain management and rehabilitation. Consequently, healthcare providers in Ukraine have been seeking assistance from international, professional bodies to improve the care offered to amputees - soldiers and civilians.\n\nPain related to an amputation is chronic and so non-pharmacological approaches, rather than pharmacological, are appealing. In Germany, Routine Health, in Düsseldorf, have developed an app-based platform which offers amputees a variety of non-pharmacological management techniques.\n\nIn the PAMELA project, we will offer amputees and therapists in Ukraine, use of this app.\n\nThe app has been adapted for use in Ukraine.\n\nThe study will be carried out in 2 phases:\n\n1. A pilot in 5 rehabilitation centers to assess feasibility of using the app during one pre-defined 8-week treatment cycle, tailored to each amputee; amputees will be offered to use the app for another 4 weeks, independently\n2. Updating the app, based on experience gained in the pilot phase and sharing the app with amputees who wish to us it.",[26,212,213,214,215,216,217],"Pain, Phantom","Pain, Acute","Pain, Chronic","Pain, Neuropathic","Rehabilitation","War-Related Trauma",[219,220,221,222,223,224,225,226,227],"Non-pharmacological treatment","App, computer","amputation, traumatic","pain, phantom","pain, acute","pain, chronic","pain, neuropathic","rehabilitation","war-related trauma","2024-09-17",{"date":230,"type":41},"2024-09-19",{"date":232,"type":20},"2024-10-15",{"date":234,"type":20},"2026-12-31",{"name":236,"class":48},"Winfried Meißner",5,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":21,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":49},"100549410","understanding-how-powered-componentry-impacts-k2-level-transfemoral-amputee-gait-100549410","NCT06433648","Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait","Inclusion Criteria:\n\n* Ages 18-95\n* A unilateral transfemoral amputation\n* At least 6 months since definitive prosthesis fitting\n* Able to walk 50 meters (55 yards) with a prosthesis without the assistance of another person.\n* Medically cleared by physician to participate in study\n* English speaking\n\nExclusion Criteria:\n\n* Weight greater than 250 pounds\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 useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.\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.","95 Years",{"count":246,"type":20},20,[85],"The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees.\n\nAim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg\u002FOttobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle.\n\nAim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only.\n\nAim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle).\n\nOur hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.",[34,26,250,251],"Amputation of Knee","Amputation; Traumatic, Limb","2024-05-28",{"date":254,"type":41},"2024-05-30",{"date":256,"type":41},"2023-05-01",{"date":258,"type":20},"2029-06-30",{"name":199,"class":48}]