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Targeted Sensory Reinnervation (TSR) in Hand Amputation

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06249594
Enrollment
3
Registered
2024-02-08
Start date
2022-05-18
Completion date
2023-08-02
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Phantom Pain, Targeted Sensory Reinervation

Keywords

Nerves, Reinervation, amputation hand, phantom pain, prevention, novel methode

Brief 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.

Interventions

PROCEDUREtargeted sensory reinervation

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

Sponsors

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

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
effects in use and reinervation (begin of sensation, localisation of sensation on the hand..)01.09.2020 - 31.03.2022Describtion of the effect of the use and reactivation of existing nerves in connection with the TSR in the delvelopment of phantom pain

Other

MeasureTime frameDescription
Start date and type of Physiotherapy01.09.2020 - 31.03.2022Type of physiotherapy: ultrasound, vibrational therapy, exercise...
Time between amputation and surgery01.09.2020 - 31.03.2022days, months or years
Date of targeted sensory reinervation (TSR)01.09.2020 - 31.03.2022Date, surgery to reinervate the nerve was performed
presence of phantom pain -and neuroma pain01.09.2020 - 31.03.2022patient survey and scale
concomittant treatment post TSR01.09.2020 - 31.03.2022dosage, indication and active agent of medication will be documented
Cause of injury or disease01.09.2020 - 31.03.2022for example: accident

Countries

Austria, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026