Targeted Sensory Reinnervation (TSR) in Hand Amputation

NCT06249594 | Completed

• 1 other identifier: TSR in Hand Amputation
• Study Type: observational
• Target: 3
• Locations: 2 countries
• Sites: 2

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.

Conditions

Targeted Sensory Reinervation; Amputation; Phantom Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (6)

• Date of targeted sensory reinervation (TSR)

  01.09.2020 - 31.03.2022

• Start date and type of Physiotherapy

  01.09.2020 - 31.03.2022

• Time between amputation and surgery

  01.09.2020 - 31.03.2022

Interventions

targeted sensory reinervation PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with upper limb amputation (planned as well as accident related) with treatment resistant (phantom-and-or neuroma) pain.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

AUVA Hospital Klagenfurt

Klagenfurt, Carinthia, 9020, Austria

Location

Brixsana Private Clinic Center for Plastic, Aesthetic and Reconstructive Surgery with Hand Surgery Competence Center for Bionic Prosthetics

Brixen, 39042, Italy

Location

Related 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.

  PMID: 34501477 BACKGROUND

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Alexander Gardetto, Doz.Dr

  Brixsana Private Clinic

  PRINCIPAL INVESTIGATOR

• Smekal Vinzenz, Dr.

  AUVA Hospital Klagenfurt, Department of Orthopaedics and Traumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 8, 2024
• Study Start: May 18, 2022
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); IT (1)