Targeted Sensory ReinervationNCT06249594
Targeted Sensory Reinnervation (TSR) in Hand Amputation
An observational study of Targeted Sensory Reinervation and Amputation, run by Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Targeted Sensory Reinervation, Amputation, Phantom Pain
- What is being tested?
- targeted sensory reinervation
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 May 2022to 2 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with upper limb amputation (planned as well as accident related) with treatment resistant (phantom-and-or neuroma) pain.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
Brixsana Private Clinic Center for Plastic, Aesthetic and Reconstructive Surgery with Hand Surgery Competence Center for Bionic Prosthetics
Brixen, 39042
About this study
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.
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.
Read more
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
- Being tested
- targeted sensory reinervation
- Keywords
- Nerves, Reinervation, amputation hand, phantom pain, prevention, novel methode
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
targeted sensory reinervationProcedure or surgery
targeted sensory reinnervation (TSR) in hand amputation by using and reactivation of existing nerves to treat and prevent phantom pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 01.09.2020 - 31.03.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start18 May 2022
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Targeted Sensory ReinervationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell
- Sponsor type
- University, hospital or other
- Collaborators
- AUVA Hospital Klagenfurt/Austria, Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA, CCSRM - Clinical Center for Studies in Regenerative Medicine
- Responsible party
- Sponsor
- Investigators
- Alexander Gardetto, Doz.Dr, Principal investigator, Brixsana Private ClinicSmekal Vinzenz, Dr., Principal investigator, AUVA Hospital Klagenfurt, Department of Orthopaedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249594
- Sponsor's protocol ID
- TSR in Hand Amputation
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34501477
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06249594
- Acronym / sponsor ID
- TSR in Hand Amputation
- Conditions
- Targeted Sensory Reinervation, Amputation, Phantom Pain
- Keywords
- Nerves, Reinervation, amputation hand, phantom pain, prevention, novel methode
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dellUniversity, hospital or other
- Collaborators
- AUVA Hospital Klagenfurt/Austria, Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA, CCSRM - Clinical Center for Studies in Regenerative Medicine
- Study start
- 18 May 2022 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with upper limb amputation (planned as well as accident related) with treatment resistant (phantom-and-or neuroma) pain.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| targeted sensory reinervationtargeted sensory reinnervation (TSR) in hand amputation by using and reactivation of existing nerves to treat and prevent phantom pain | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 34501477Gardetto 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Gardetto, Doz.Dr principal investigator
Brixsana Private Clinic
Smekal Vinzenz, Dr. principal investigator
AUVA Hospital Klagenfurt, Department of Orthopaedics and Traumatology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Targeted Sensory Reinervation and Amputation, run by Brixsana Private Clinic - Centro di Chirurgia Plastica, Estetica ed Ricostruttiva con Chirurgia dell at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects in use and reinervation (begin of sensation, localisation of sensation on the hand..) (time frame: 01.09.2020 - 31.03.2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06249594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.