[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amputation-surgical\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amputation-surgical":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,78,106,135,161],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100623169","early-postoperative-pain-following-a-limb-amputation-100623169",false,"NCT07393139","Early Postoperative Pain Following a Limb Amputation","Early Postoperative Pain and Functional Recovery Following a Limb Amputation: a Retrospective Observational Study.","Pain-Amp","Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Patients who underwent an amputation to any limb, regardless of location or diagnosis\n\nExclusion Criteria:\n\n* Patients with severe cognitive impairment or diagnosed with dementia\n* Patients deceased or in critical conditions within 48 hours of the intervention\n* Previous amputation to any limb\n* Admission to the hospital because of a stump revision","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","The primary aim of this study is to characterize the trajectory of pain and functional recovery in the first post-operative period following a limb amputation. Secondarily, this study aims to conduct an exploratory analysis to evaluate potential associations between clinical, demographical and therapeutical variables and primary outcomes including pain intensity, pain control and functional recovery.",[25,26,27],"Amputation, Surgical","Pain Management","Rehabilitation",[29,30,31],"Phantom limb pain","Amputation","Post-operative","RECRUITING","2026-01-30",{"date":35,"type":36},"2026-02-06","ACTUAL",{"date":38,"type":36},"2026-01-09",{"date":40,"type":21},"2026-04",{"name":42,"class":43},"Istituto Ortopedico Rizzoli","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100571360","prevention-of-postamputation-pain-with-targeted-muscle-reinnervation-100571360","NCT06719245","Prevention of PostAmputation Pain With Targeted Muscle Reinnervation","Prevention of PostAmputation Pain With Targeted Muscle Reinnervation: A National, Multicenter, Randomized, Sham-controlled Superiority Trial, Comparing Standard Neurectomy With Targeted Muscle Reinnervation in Amputations of the Lower Extremities","PreventPAP","Inclusion criteria\n\n* Patients aged between 18 and 75 years old.\n* Scheduled for a transtibial, through-knee, or transfemoral amputation as a primary or secondary sequela of vascular disease.\n\nExclusion criteria\n\n* Insensate limbs at the level of amputation.\n* Complex Regional Pain Syndrome.\n* Existing neuroma or prior neuroma surgery in the affected limb.\n* Undergoing radiotherapy on the affected limb.\n* Cognitive impairment, or delirium at the time of consent.\n* Patients who are unfit for general anesthesia.\n* No nerve surgeon trained in the TMR procedure is available","75 Years",{"count":55,"type":21},203,"INTERVENTIONAL",[58],"NA","The goal of this study is to compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients who received a lower extremity amputation (LEA) with standard nerve handling (neurectomy) versus those who received Targeted Muscle Reinnervation (TMR).\n\nPatients between 18 and 75 years old, scheduled for an LEA (transfemoral to transtibial) as a primary or secondary sequela of vascular disease, are randomized into standard neurectomy or TMR. TMR is a frequently studied surgical technique and prevents neuroma formation by rerouting a cut mixed nerve end to a functional motor nerve.\n\nThe investigators hypothesize that TMR during amputation surgery will significant improve PostAmputation Pain (PAP), quality of life, participation in family life and society, and reduction of health-related costs. Participants will be asked to complete multiple online questionnaires postoperatively regarding these outcomes at five evaluation moments (at 2 weeks, and at 3, 6, 9, and 12 months).",[25,61,62,63],"Phantom Limb Pain","Neuroma Amputation","Surgery",[65,30,66,67],"TMR","Phantom pain","Neuroma","2025-09-15",{"date":70,"type":36},"2025-09-19",{"date":72,"type":36},"2024-12-31",{"date":74,"type":21},"2028-01-01",{"name":76,"class":43},"Leiden University Medical Center",7,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100600835","comparison-between-digital-nerve-microanastomosis-and-traction-neurectomy-in-post-digital-amputation-pain-100600835","NCT07102654","Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain","Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain: A Prospective Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients who have undergone a traumatic digital amputation\n* Patients treated with one of the two following techniques: microanastomosis of digital nerves or traction neurectomy\n* Postoperative follow-up of at least 6 months\n\nExclusion Criteria:\n\n* Patients treated with a surgical intervention other than microanastomosis of digital nerves or traction neurectomy for digital amputation\n* Non-traumatic amputations (e.g., cancer or infection)\n* Follow-up of less than 6 months\n* Patients with pre-existing peripheral neuropathy",{"count":86,"type":21},50,"The goal of this prospective observational study is to assess the post-operative pain in adults with digital amputation following two different surgical interventions: microanastomosis of digital nerves or traction neurectomy. The main questions it aims to answer are:\n\n* Which surgical intervention results in less post-operative pain?\n* Which surgical intervention leads to fewer symptoms after six months?\n* Which surgical intervention is associated with fewest post-operative complications? Participants will complete a Visual Analog Scale (VAS) to assess the pain and the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) to evaluate the disabilities.\n\nThe researchers will assess post-operative complications during follow-up appointments.",[89,90,91,25],"Amputation Stump","Amputation Neuroma","Amputation, Traumatic\u002FSurgery",[93,94,95,96],"microanastomosis","traction neurectomy","digital amputation","digital nerve","NOT_YET_RECRUITING","2025-09-11",{"date":68,"type":36},{"date":101,"type":21},"2025-12-01",{"date":103,"type":21},"2026-07-01",{"name":105,"class":43},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":56,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":44},"100515327","improving-prosthetic-arms-for-amputee-a-better-fit-and-more-functionality-100515327","NCT05990062","Improving Prosthetic Arms for Amputee: A Better Fit and More Functionality","The Advancement of a New Variable-Compliance Socket and Frame System for Transradial Amputees to Optimize Socket Fit and Upper Limb Function","KSH","Inclusion Criteria:\n\n* Unilateral transradial arm amputation\n* Possession of a functioning and wearable previously fit prosthetic arm of any type\n* Residual limb length of at least 4 inches from the lateral epicondyle to the distal tip\n* Residual limb length less than or equal to that allowing a clearance of 1.5 inches from a fitted wrist\n* Must have at least 5-years of prosthetic use experience (For Phase 1 \\& 2)\n* Must have at least 1-year of prosthetic use experience (For Phase 3 only)\n\nExclusion Criteria:\n\n* Current open sores or incisions, Heterotopic ossification (HO), traumatic neuromas, or any other condition preventing the wearing of a prosthetic socket\n* Residual limb length less than 4 inches\n* Residual limb length greater than that allowing 1.5 inches clearance from a fitted wrist.\n\nThe investigators will make every effort to recruit Veterans. If its found that it is not possible to recruit enough Veterans, the investigators will perform a non-Veteran amendment to this protocol.",true,{"count":116,"type":21},25,[58],"This research and development will improve upon and investigate the potential validity of an innovative new transradial socket and harness design (the KSH system) that offers an alternative to standard hard sockets and rubber liners with a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The project consists of designing, custom fitting and evaluating the function and comfort of the this new novel system. The study will take place in 3 phases; Phase 1, five experienced Veterans with transradial arm amputations will be recruited to provide guidance and to assist with the design and development. Experienced end-user Veterans and Clinical staff will work together to assist with design, develop the fitting process and working with engineers on the design of a completely digital fitting device for measuring the residual limb and locating bony prominences of the limb to inform the socket design. Phase 2, testing and assessment, the design and process validation will take place with the five Veteran upper transradial arm amputees Phase 3, an additional 20 Veterans with transradial arm amputations will be recruited and fit with the KSH system and undergo a series of evaluative tests. Veterans will perform a series of static and dynamic tasks to evaluate function, comfort and load bearing failure. The primary goal of this study is to improve upon the current preliminary prototype and to test it with a broader population of potential users to help advance the engineering and design, and to learn the potential to fit a range of Veterans with transradial amputations.",[25],[121,122,123,124],"function","breathability","comfort","transradial","2025-06-25",{"date":127,"type":36},"2025-06-26",{"date":129,"type":36},"2025-06-01",{"date":131,"type":21},"2028-09-30",{"name":133,"class":134},"VA Office of Research and Development","FED",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":56,"phases":145,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":44},"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":144,"type":21},12,[58],"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.",[30,148,25,149],"Amputation, Traumatic","Upper Limb Amputation Above Elbow (Injury)",[151],"eOPRA for transhumeral amputees","2025-06-12",{"date":154,"type":36},"2025-06-24",{"date":156,"type":21},"2026-01-01",{"date":158,"type":21},"2029-05-31",{"name":160,"class":43},"Shirley Ryan AbilityLab",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":44},"100558576","analyzing-anesthetic-techniques-in-diabetic-foot-amputation-100558576","NCT06552910","Analyzing Anesthetic Techniques in Diabetic Foot Amputation","Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes","Inclusion Criteria:\n\nPatients diagnosed with diabetic foot requiring amputation. Patients who underwent toe, ankle, or foot amputation. Patients aged 18 years or older.\n\nExclusion Criteria:\n\nPatients under the age of 18. Amputations performed for reasons other than diabetic foot. Patients with incomplete or insufficient medical records.",{"count":169,"type":21},450,"Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes\n\nIntroduction:\n\nDiabetic foot is a severe complication of diabetes, often resulting in ulceration, osteomyelitis, and gangrene. Amputation or surgical debridement is the standard treatment for advanced cases. The study aims to evaluate the outcomes of different anesthetic techniques in diabetic foot amputation, specifically comparing peripheral nerve block (PNB) and general anesthesia.\n\nObjective:\n\nTo assess the impact of anesthetic procedures on outcomes in diabetic foot amputation cases using inpatient data. The hypothesis is that PNB will result in fewer postoperative complications than general anesthesia-primary outcome: 30-day mortality; secondary outcomes: composite morbidity and hospital discharge duration.\n\nMaterials and Methods:\n\nThis retrospective chart review will analyze medical records of patients with diabetic foot at Ankara Bilkent City Hospital from 2021 to 2023. Inclusion criteria: patients who underwent toe, ankle, or foot amputations. Exclusion criteria: patients under 18, amputations for non-diabetic reasons, and insufficient medical data. Data will include patient demographics, preoperative medications, comorbidities, and surgical details. Major complications, secondary outcomes, and mortality will be primary measures.\n\nStatistical Analysis:\n\nDescriptive statistics will summarize patient characteristics. Chi-square and Student t-tests will analyze associations between anesthesia type and postoperative outcomes. Kaplan-Meier survival analysis will compare hospital stay durations. Logistic regression will adjust for confounders and assess the impact of anesthetics on complications. Results will be significant at p \\\u003C 0.05.",[172,25],"Diabetic Foot",[172,174,175,25],"Nerve Block","Diabetes Complications","2024-09-02",{"date":178,"type":36},"2024-09-05",{"date":180,"type":36},"2024-07-01",{"date":182,"type":21},"2024-12-30",{"name":184,"class":43},"Ankara City Hospital Bilkent"]