Clinical trial NCT06249594: Targeted Sensory Reinnervation (TSR) in Hand Amputation
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Targeted Sensory Reinervation
Amputation
Phantom Pain
Keywords: Nerves
Reinervation
amputation hand
phantom pain
prevention
novel methode
Lead sponsor: Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell
Sponsor class: OTHER
Collaborators: name: AUVA Hospital Klagenfurt/Austria
name: Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
name: CCSRM - Clinical Center for Studies in Regenerative Medicine
First posted: 2024-02-08
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: effects in use and reinervation (begin of sensation, localisation of sensation on the hand..)
timeFrame: 01.09.2020 - 31.03.2022
Secondary outcomes:
Other outcomes:
measure: Date of targeted sensory reinervation (TSR)
timeFrame: 01.09.2020 - 31.03.2022
measure: Start date and type of Physiotherapy
timeFrame: 01.09.2020 - 31.03.2022
measure: Time between amputation and surgery
timeFrame: 01.09.2020 - 31.03.2022
measure: Cause of injury or disease
timeFrame: 01.09.2020 - 31.03.2022
measure: presence of phantom pain -and neuroma pain
timeFrame: 01.09.2020 - 31.03.2022
measure: concomittant treatment post TSR
timeFrame: 01.09.2020 - 31.03.2022
Locations:
city: Klagenfurt
country: Austria
facility: AUVA Hospital Klagenfurt
state: Kärnten
city: Brixen
country: Italy
facility: Brixsana Private Clinic Center for Plastic, Aesthetic and Reconstructive Surgery with Hand Surgery Competence Center for Bionic Prosthetics
Study officials:
affiliation: Brixsana Private Clinic
name: Alexander Gardetto, Doz.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: AUVA Hospital Klagenfurt, Department of Orthopaedics and Traumatology
name: Smekal Vinzenz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.