Targeted Sensory Reinnervation (TSR) in Hand Amputation

Amputation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249594
• Other study ID #: TSR in Hand Amputation
• Status: Completed
• Start date: May 18, 2022
• Est. completion date: August 2, 2023

Study information

• Verified date: January 2024
• Source: Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 2, 2023
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation
• Phantom Limb
• Phantom Pain

Intervention

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

Locations

Country	Name	City	State
Austria	AUVA Hospital Klagenfurt	Klagenfurt	Kärnten
Italy	Brixsana Private Clinic Center for Plastic, Aesthetic and Reconstructive Surgery with Hand Surgery Competence Center for Bionic Prosthetics	Brixen

Sponsors (4)

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

Countries where clinical trial is conducted

Austria,  Italy, 

References & 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. — View Citation

Outcome

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