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Prevention study for Amputation, Surgical
Official title Prevention of PostAmputation Pain With Targeted Muscle Reinnervation
ClinicalTrials.gov ID: NCT06719245
What this study is testing
- What it's testing
- 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 secondary sequela of vascular disease, are randomized into standard neurectomy or TMR.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- Insensate limbs at the level of amputation.
- Complex Regional Pain Syndrome.
- Existing neuroma or prior neuroma surgery in the affected limb.
- Undergoing radiotherapy on the affected limb.
- Cognitive impairment, or delirium at the time of consent.
- Patients who are unfit for general anesthesia.
See the full eligibility 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.
- Insensate limbs at the level of amputation.
- Complex Regional Pain Syndrome.
- Existing neuroma or prior neuroma surgery in the affected limb.
- Undergoing radiotherapy on the affected limb.
- Cognitive impairment, or delirium at the time of consent.
- Patients who are unfit for general anesthesia.
- No nerve surgeon trained in the TMR procedure is available
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
- Zwolle, Overijssel, Netherlands
- Leiden, South Holland, Netherlands
- Leiderdorp, South Holland, Netherlands
- Rotterdam, South Holland, Netherlands
- The Hague, South Holland, Netherlands
- Utrecht, Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands; Zwolle, Overijssel, Netherlands; Leiden, South Holland, Netherlands; Leiderdorp, South Holland, Netherlands; Rotterdam, South Holland, Netherlands; The Hague, South Holland, Netherlands and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.