Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-03-05 @ 3:45 AM
Study NCT ID:
NCT02797457
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2031-10-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-08', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2031-10-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment cost', 'timeFrame': '36 months', 'description': 'Treatment cost of double amputated patients by bilateral allograft of the hands and forearms or by prostheses'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bilateral amputation of the forearms', 'Bilateral allograft', 'Prosthetic forehands', 'Medical economic evaluation'], 'conditions': ['Bilateral Traumatic Amputation of Upper Limbs']}, 'descriptionModule': {'briefSummary': 'The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.\n\nThe management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensitivity , the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.\n\nSince January 2000, date of the first double hand graft, six bilateral grafts of hands have been performed at the Hospices Civils de Lyon. This first study reported the feasibility of the graft. The functional results obtained after the double transplant have allowed patients to recover complete autonomy for everyday activities, at the price of an immunosuppressive treatment. We have found that these very good functional results are maintained over time and, for a certain number of patients, to return to work which is a factor of social integration.\n\nThe rate of medical complications (metabolic, infectious, oncological), essentially related to the immunosuppressive treatment, is not greater to that found for other types of graft, but are considered as a limiting factor for the development of this strategy. These results are confirmed by international experience that is of the same order. Only a few rare cases of re-amputation have been reported in patients for whom the immunosuppressive treatment was discontinued or following vascular thrombosis.\n\nA new study is required to continue this evaluation and to compare double graft to prostheses in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The results of this study will allow the placement of these strategies in the management of patients with double amputation of the hands and forearms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria common to the 2 groups of patients (allograft group and protheses group):\n\n* Adult aged 18 to 60 years\n* Double amputated of both forearms\n\nTransplant eligibility criteria (for allograft group)\n\n* Minimum interval between amputation and graft of three months (no maximal delay)\n* Absence of previous psychiatric history contraindicating the graft and psychological maturity, according to two psychiatrists who have evaluated the patient\n* No previous history of malignant tumor in remission for less than 5 years\n* American Society of Anesthesiology (ASA) score ≤ 2\n* New York Heart Association (NYHA) grade ≥ 1\n* Creatinine clearance ≥ 60 ml/min/1.73m²\n* Absence of badly controlled sever hypertension\n\nExclusion Criteria:\n\n* Mono amputated patients\n* Malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%'}, 'identificationModule': {'nctId': 'NCT02797457', 'acronym': 'ARMEDIC', 'briefTitle': 'Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms', 'orgStudyIdInfo': {'id': '69HCL15_0084'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Allograft', 'description': 'Bilateral allograft of the hands and forearms.', 'interventionNames': ['Procedure: Bilateral allograft of the hands and forearms.']}, {'type': 'OTHER', 'label': 'Prostheses', 'description': 'Prosthetic forehands', 'interventionNames': ['Procedure: Prosthetic forehands']}], 'interventions': [{'name': 'Bilateral allograft of the hands and forearms.', 'type': 'PROCEDURE', 'description': 'Bilateral allograft of the hands and forearms.', 'armGroupLabels': ['Allograft']}, {'name': 'Prosthetic forehands', 'type': 'PROCEDURE', 'description': 'Prosthetic forehands', 'armGroupLabels': ['Prostheses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62600', 'city': 'Berck', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric CHARLATE, MD', 'role': 'CONTACT'}, {'name': 'Frédéric CHARLATE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale', 'geoPoint': {'lat': 50.4, 'lon': 1.6}}, {'zip': '33520', 'city': 'Bruges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rémi KLOTZ, MD', 'role': 'CONTACT'}, {'name': 'Rémi KLOTZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies', 'geoPoint': {'lat': 44.88287, 'lon': -0.61222}}, {'zip': '92140', 'city': 'Clamart', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric LAPEYRE, MD', 'role': 'CONTACT'}, {'name': 'Eric LAPEYRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy", 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '59260', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hervé DELAHAYE, MD', 'role': 'CONTACT'}, {'name': 'Hervé DELAHAYE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69005', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle LAROYENNE, MD', 'role': 'CONTACT'}, {'name': 'Isabelle LAROYENNE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69427', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lionel BADET, MD', 'role': 'CONTACT'}, {'name': 'Lionel BADET, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '01700', 'city': 'Miribel', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Renaud TAVERNIER, MD', 'role': 'CONTACT'}, {'name': 'Renaud TAVERNIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari', 'geoPoint': {'lat': 45.8258, 'lon': 4.9544}}, {'zip': '54042', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean PAYSANT, MD', 'role': 'CONTACT'}, {'name': 'Jean PAYSANT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '56275', 'city': 'Ploemeur', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre VERSCHOORE, MD', 'role': 'CONTACT'}, {'name': 'Pierre VERSCHOORE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape', 'geoPoint': {'lat': 47.73512, 'lon': -3.42952}}, {'zip': '69230', 'city': 'Saint-Genis-Laval', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles RODE, MD', 'role': 'CONTACT'}, {'name': 'Gilles RODE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.69542, 'lon': 4.79316}}, {'zip': '94460', 'city': 'Valenton', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence GUILLOU, MD', 'role': 'CONTACT'}, {'name': 'Florence GUILLOU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné", 'geoPoint': {'lat': 48.74527, 'lon': 2.46467}}], 'centralContacts': [{'name': 'Lionel BADET, M', 'role': 'CONTACT', 'email': 'lionel.badet@chu-lyon.fr', 'phone': '4 72 11 91 91', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}