Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06249594
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2024-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Sensory Reinnervation (TSR) in Hand Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Date of targeted sensory reinervation (TSR)', 'timeFrame': '01.09.2020 - 31.03.2022', 'description': 'Date, surgery to reinervate the nerve was performed'}, {'measure': 'Start date and type of Physiotherapy', 'timeFrame': '01.09.2020 - 31.03.2022', 'description': 'Type of physiotherapy: ultrasound, vibrational therapy, exercise...'}, {'measure': 'Time between amputation and surgery', 'timeFrame': '01.09.2020 - 31.03.2022', 'description': 'days, months or years'}, {'measure': 'Cause of injury or disease', 'timeFrame': '01.09.2020 - 31.03.2022', 'description': 'for example: accident'}, {'measure': 'presence of phantom pain -and neuroma pain', 'timeFrame': '01.09.2020 - 31.03.2022', 'description': 'patient survey and scale'}, {'measure': 'concomittant treatment post TSR', 'timeFrame': '01.09.2020 - 31.03.2022', 'description': 'dosage, indication and active agent of medication will be documented'}], 'primaryOutcomes': [{'measure': 'effects in use and reinervation (begin of sensation, localisation of sensation on the hand..)', 'timeFrame': '01.09.2020 - 31.03.2022', 'description': 'Describtion of the effect of the use and reactivation of existing nerves in connection with the TSR in the delvelopment of phantom pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nerves', 'Reinervation', 'amputation hand', 'phantom pain', 'prevention', 'novel methode'], 'conditions': ['Targeted Sensory Reinervation', 'Amputation', 'Phantom Pain']}, 'referencesModule': {'references': [{'pmid': '34501477', 'type': 'BACKGROUND', 'citation': 'Gardetto A, Baur EM, Prahm C, Smekal V, Jeschke J, Peternell G, Pedrini MT, Kolbenschlag J. Reduction of Phantom Limb Pain and Improved Proprioception through a TSR-Based Surgical Technique: A Case Series of Four Patients with Lower Limb Amputation. J Clin Med. 2021 Sep 6;10(17):4029. doi: 10.3390/jcm10174029.'}]}, 'descriptionModule': {'briefSummary': 'If a person has to have a part of their body amputated, in this case their hand, the patient then lacks information about the missing limb, which in many cases leads to pain that severely restricts their quality of life and participation in everyday life.\n\nThis is usually phantom and/or neuroma pain. Phantom pain is usually caused by many different mechanisms and occurs in 80-90% of patients.\n\nPain caused by terminal neuromas affects 13-32% of amputees and manifests itself as residual limb pain.\n\nA neuroma itself is a benign lump that can develop at the site of the defect after a nerve has been severed (neurectomy).\n\nIn some cases the impairment is so severe that prosthetic tolerance, functional independence and quality of life can be severely affected.\n\nNumerous treatment options for these types of pain are far from satisfactory for many patients and remain a major challenge for both the clinician and the person affected.\n\nIt is often no longer possible for the patients to pursue a profession or hobby due to the pain as well as due to the pain medication required and its possible side effects.\n\nSurgical intervention can therefore be considered for patients who do not (or no longer) respond to conservative pain treatment.\n\nIn recent years, many surgical approaches have been introduced to treat or prevent post-amputee pain.\n\nOne of these methods can make it possible to create an authentic feeling of the missing limb and thus reduce or eliminate phantom pain by means of targeted sensory reinnervation (TSR) of the lost body part.\n\nSensory reinnervation means that a nerve which enables a (sensory) perception associated with a sense is "redirected" to a new area of the body and can therefore fulfil at least part of its task again.\n\nIn this case, an authentic feeling of the lost body part.\n\nThe aim of this retrospective data-analysis is to evaluate data from patients with hand amputation (planned surgery or caused by accident/infection..) who have undergone TSR surgery to treat or prevent phantom and neuro-pain with regard to different parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with upper limb amputation (planned as well as accident related) with treatment resistant (phantom-and-or neuroma) pain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with amputations of the hand\n* Patient with programmed hand amputation\n* Patients with treatment-resistant pain\n* Patients with treatment-resistant phantom- and neuroma pain\n* Patients with performed TSR Surgery\n* Aged at least 18 years\n* Patient must be alive at the time of medical record review\n\nExclusion Criteria:\n\n* Patients enrolled in another interventional clinical trial\n* An injured skin area for reinnervation at the volar side of the forearm, as well as an injured median or ulnar nerve.'}, 'identificationModule': {'nctId': 'NCT06249594', 'briefTitle': 'Targeted Sensory Reinnervation (TSR) in Hand Amputation', 'organization': {'class': 'OTHER', 'fullName': 'Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell'}, 'officialTitle': 'Real-World Treatment Patterns, Clinical Outcomes of a Novel Method in Targeted Sensory Re-innervation in Hand Amputation by Using and Reactivation of Existing Nerves to Treat and Prevent Phantom Pain A Retrospective, Non-interventional, Multinational, Multi-center Retrospective Data Analysis to Describe the Treatment Patterns and Clinical Outcomes in a Novel Method in Targeted Sensory Reinnervation in Patients With Hand Amputation by Using and Reactivation of Existing Nerves to Treat and Prevent Phantom Pain.', 'orgStudyIdInfo': {'id': 'TSR in Hand Amputation'}}, 'armsInterventionsModule': {'interventions': [{'name': 'targeted sensory reinervation', 'type': 'PROCEDURE', 'description': 'targeted sensory reinnervation (TSR) in hand amputation by using and reactivation of existing nerves to treat and prevent phantom pain'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9020', 'city': 'Klagenfurt', 'state': 'Carinthia', 'country': 'Austria', 'facility': 'AUVA Hospital Klagenfurt', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': '39042', 'city': 'Brixen', 'country': 'Italy', 'facility': 'Brixsana Private Clinic Center for Plastic, Aesthetic and Reconstructive Surgery with Hand Surgery Competence Center for Bionic Prosthetics', 'geoPoint': {'lat': 46.71503, 'lon': 11.65598}}], 'overallOfficials': [{'name': 'Alexander Gardetto, Doz.Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brixsana Private Clinic'}, {'name': 'Smekal Vinzenz, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AUVA Hospital Klagenfurt, Department of Orthopaedics and Traumatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell', 'class': 'OTHER'}, 'collaborators': [{'name': 'AUVA Hospital Klagenfurt/Austria', 'class': 'UNKNOWN'}, {'name': 'Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA', 'class': 'OTHER_GOV'}, {'name': 'CCSRM - Clinical Center for Studies in Regenerative Medicine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}