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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06249594
Other study ID # TSR in Hand Amputation
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 18, 2022
Est. completion date August 2, 2023

Study information

Verified date January 2024
Source Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. This is usually phantom and/or neuroma pain. Phantom pain is usually caused by many different mechanisms and occurs in 80-90% of patients. Pain caused by terminal neuromas affects 13-32% of amputees and manifests itself as residual limb pain. A neuroma itself is a benign lump that can develop at the site of the defect after a nerve has been severed (neurectomy). In some cases the impairment is so severe that prosthetic tolerance, functional independence and quality of life can be severely affected. Numerous 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. It 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. Surgical intervention can therefore be considered for patients who do not (or no longer) respond to conservative pain treatment. In recent years, many surgical approaches have been introduced to treat or prevent post-amputee pain. One 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. Sensory 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. In this case, an authentic feeling of the lost body part. The 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.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date August 2, 2023
Est. primary completion date August 2, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with amputations of the hand - Patient with programmed hand amputation - Patients with treatment-resistant pain - Patients with treatment-resistant phantom- and neuroma pain - Patients with performed TSR Surgery - Aged at least 18 years - Patient must be alive at the time of medical record review Exclusion Criteria: - Patients enrolled in another interventional clinical trial - An injured skin area for reinnervation at the volar side of the forearm, as well as an injured median or ulnar nerve.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
targeted sensory reinervation
targeted sensory reinnervation (TSR) in hand amputation by using and reactivation of existing nerves to treat and prevent phantom pain

Locations

Country Name City State
Austria AUVA Hospital Klagenfurt Klagenfurt Kärnten
Italy Brixsana Private Clinic Center for Plastic, Aesthetic and Reconstructive Surgery with Hand Surgery Competence Center for Bionic Prosthetics Brixen

Sponsors (4)

Lead Sponsor Collaborator
Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell AUVA Hospital Klagenfurt/Austria, CCSRM - Clinical Center for Studies in Regenerative Medicine, Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

Countries where clinical trial is conducted

Austria,  Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Date of targeted sensory reinervation (TSR) Date, surgery to reinervate the nerve was performed 01.09.2020 - 31.03.2022
Other Start date and type of Physiotherapy Type of physiotherapy: ultrasound, vibrational therapy, exercise... 01.09.2020 - 31.03.2022
Other Time between amputation and surgery days, months or years 01.09.2020 - 31.03.2022
Other Cause of injury or disease for example: accident 01.09.2020 - 31.03.2022
Other presence of phantom pain -and neuroma pain patient survey and scale 01.09.2020 - 31.03.2022
Other concomittant treatment post TSR dosage, indication and active agent of medication will be documented 01.09.2020 - 31.03.2022
Primary effects in use and reinervation (begin of sensation, localisation of sensation on the hand..) Describtion of the effect of the use and reactivation of existing nerves in connection with the TSR in the delvelopment of phantom pain 01.09.2020 - 31.03.2022
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