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 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Targeted Muscle Reinnervation (TMR)
Procedure/Surgery
In short: each transected nerve is identified after amputation and is dissected proximally for length. A nerve stimulator is used to identify functional motor nerve branches. Near the point where the motor branch enters the muscle, the motor nerve branch is transected and an end-to-end coaptation is performed with a nearby amputated nerve.
Standard neurectomy
Procedure/Surgery
During the amputation a standard neurectomy will be performed based on the surgeons preference. Standard neurectomy will include cutting of the nerve, with or without traction, with or without coagulation, and with or without infiltration with a local anesthetic (i.e., ropivacaine) or phenol. Ligation of the nerve will not be allowed.

Treatment groups

203 Participants

are divided into 2 treatment groups

Group A: Standard Neurectomy (control)Other 1 intervention

Group B: Targeted Muscle Reinnervation (intervention)Other 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative residual limb pain

Postoperative residual limb pain will be scored on the 11-point (0-10) Numeric Rating Scale (NRS) for 30 consecutive days in a pain diary. A higher score indicates more pain.

Time frame

at 12 months

2

Postoperative phantom limb pain

Postoperative phantom limb pain will be scored on the 11-point (0-10) Numeric Rating Scale (NRS) for 30 consecutive days in a pain diary. A higher score indicates more pain.

Time frame

at 12 months

3

Postoperative pain behavior

Postoperative pain behavior will be scored using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Behavior Short Form 7a. The results will be scored on a scale from 7 to 35 points, with a higher score indicating that pain has a greater influence on behavior.

Time frame

at 12 months

4

Postoperative pain interference

Postoperative pain interference will be scored using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 8a. The results will be scored on a scale from 8 to 40 points, where a higher score indicates greater interference of pain with daily life

Time frame

at 12 months

Secondary outcomes

1

Postoperative residual limb pain

Postoperative residual limb pain will be scored on the 11-point (0-10) Numeric Rating Scale (NRS) at one timepoint. A higher score indicates more pain.

Time frame

at 3, 6, and 9 months

2

Postoperative phantom limb pain

Postoperative phantom limb pain will be scored on the 11-point (0-10) Numeric Rating Scale (NRS) at one timepoint. A higher score indicates more pain.

Time frame

at 3, 6, and 9 months

3

Postoperative pain behavior

Postoperative pain behavior will be scored using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Behavior Short Form 7a. The results will be scored on a scale from 7 to 35 points, with a higher score indicating that pain has a greater influence on behavior.

Time frame

at 3, 6, and 9 months

4

Postoperative pain interference

Postoperative pain interference will be scored using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 8a. The results will be scored on a scale from 8 to 40 points, where a higher score indicates greater interference of pain with daily life

Time frame

at 3, 6, and 9 months

Other outcomes

1

Surgical time

Surgical time measured in minutes

Time frame

at 0 months

2

Length of hospital stay

Postoperative length of stay in the hospital

Time frame

at 0 months

3

Adverse events

i.e., infection, rebleed. Scored with the Clavien-Dindo score form 1 to 5. A higher score indicates a more severe complication.

Time frame

30 days postoperative

Prevention of PostAmputation Pain With Targeted Muscle Reinnervation

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts