Actively Recruiting
Prevention of PostAmputation Pain With Targeted Muscle Reinnervation
Led by Leiden University Medical Center · Updated on 2025-09-19
203
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
A
Alrijne Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. TMR is a frequently studied surgical technique and prevents neuroma formation by rerouting a cut mixed nerve end to a functional motor nerve. The investigators hypothesize that TMR during amputation surgery will significant improve PostAmputation Pain (PAP), quality of life, participation in family life and society, and reduction of health-related costs. Participants will be asked to complete multiple online questionnaires postoperatively regarding these outcomes at five evaluation moments (at 2 weeks, and at 3, 6, 9, and 12 months).
CONDITIONS
Official Title
Prevention of PostAmputation Pain With Targeted Muscle Reinnervation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ
Not Yet Recruiting
2
Isala Zwolle
Zwolle, Overijssel, Netherlands, 8025 AB
Not Yet Recruiting
3
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
4
Alrijne Zorggroep
Leiderdorp, South Holland, Netherlands, 2353 GA
Not Yet Recruiting
5
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Not Yet Recruiting
6
Haaglanden Medisch Centrum
The Hague, South Holland, Netherlands, 2512 VA
Not Yet Recruiting
7
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX
Not Yet Recruiting
Research Team
J
Justus L Groen, Md PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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