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.

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Phantom Pain; Targeted Sensory Reinervation
• Intervention / Treatment: Procedure: targeted sensory reinervation

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Austria
  • Kärnten
    • Klagenfurt, Kärnten, Austria, 9020
      • AUVA Hospital Klagenfurt
• Italy
  • Brixen, Italy, 39042
    • Brixsana Private Clinic Center for Plastic, Aesthetic and Reconstructive Surgery with Hand Surgery Competence Center for Bionic Prosthetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell
• Collaborators: Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA; AUVA Hospital Klagenfurt/Austria; CCSRM - Clinical Center for Studies in Regenerative Medicine
• Investigators: Principal Investigator: Alexander Gardetto, Doz.Dr, Brixsana Private Clinic; Principal Investigator: Smekal Vinzenz, Dr., AUVA Hospital Klagenfurt, Department of Orthopaedics and Traumatology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): August 2, 2023
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: prevention; phantom pain; Nerves; Reinervation; amputation hand; novel methode
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: TSR in Hand Amputation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No