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Completed

NCT Number: NCT06249594

Targeted Sensory Reinnervation (TSR) in Hand Amputation

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

AUVA Hospital Klagenfurt, Klagenfurt, Carinthia, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

targeted sensory reinervation

Procedure

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

Primary outcomes

  1. effects in use and reinervation (begin of sensation, localisation of sensation on the hand..)

    Time frame: 01.09.2020 - 31.03.2022

    Describtion of the effect of the use and reactivation of existing nerves in connection with the TSR in the delvelopment of phantom pain

Other outcomes

  1. Date of targeted sensory reinervation (TSR)

    Time frame: 01.09.2020 - 31.03.2022

    Date, surgery to reinervate the nerve was performed

  2. Start date and type of Physiotherapy

    Time frame: 01.09.2020 - 31.03.2022

    Type of physiotherapy: ultrasound, vibrational therapy, exercise...

  3. Time between amputation and surgery

    Time frame: 01.09.2020 - 31.03.2022

    days, months or years

  4. Cause of injury or disease

    Time frame: 01.09.2020 - 31.03.2022

    for example: accident

  5. presence of phantom pain -and neuroma pain

    Time frame: 01.09.2020 - 31.03.2022

    patient survey and scale

  6. concomittant treatment post TSR

    Time frame: 01.09.2020 - 31.03.2022

    dosage, indication and active agent of medication will be documented

Sponsors and collaborators

Lead sponsor

Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell

Other

Collaborators

  • AUVA Hospital Klagenfurt/Austria
  • CCSRM - Clinical Center for Studies in Regenerative Medicine
  • Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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