Targeted Muscle Reinnervation for Post-Amputation Pain
Prevention of PostAmputation Pain With Targeted Muscle Reinnervation
Recruiting
N/A
Interventional Study
Amputation, Surgical
Phantom Limb Pain
Neuroma Amputation
Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 203 (estimated)
- Sponsor
- Leiden University Medical Center · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 75 who will undergo a lower leg or thigh amputation due to blood vessel disease. Participants will receive one of two surgical techniques and complete surveys about their pain and quality of life over the next year.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 75 years old.
- I am scheduled for a transtibial or transfemoral amputation due to vascular disease.
You may not be able to join if
- I have no feeling in the part of my body that will be amputated.
- I have Complex Regional Pain Syndrome.
- I have an existing neuroma or have had neuroma surgery on the same limb.
- I am receiving radiotherapy on the affected limb.
- I have cognitive impairment or am delirious at the time of consent.
- I am unfit for general anesthesia.
- There is no trained nerve surgeon available to perform the TMR procedure.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
The goal of this study is to compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients who received a lower extremity amputation (LEA) with standard nerve handling (neurectomy) versus those who received Targeted Muscle Reinnervation (TMR).
Patients between 18 and 75 years old, scheduled for an LEA (transfemoral to transtibial) as a primary or seco…
Trial Locations
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Eligibility Criteria
Inclusion criteria
* Patients aged between 18 and 75 years old.
* Scheduled for a transtibial, through-knee, or transfemoral amputation as a primary or secondary sequela of vascular disease.
Exclusion criteria
* Insensate limbs at the level of amputation.
* Complex Regional Pain Syndrome.
* Exist…
Contacts