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Regenerative Medicine

Surgical Treatments for Postamputation Pain

N/A

Recruiting

Led By Max Ortiz Catalan, PhD

Research Sponsored by Center for Bionics and Pain Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have a major limb amputation

Participant must have an average residual limb pain score equal or greater than 4 on the Numerical Rating Scale (NRS, 0-10) after the baseline period

Must not have

Neurological or other conditions that affect nerve regeneration for the nerve to be treated

Active infection in the residual limb

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to12-month post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial compares 3 surgical treatments to reduce pain in amputated limbs. Patients will be followed up for 4 years to compare effectiveness.

Who is the study for?

This trial is for adults over 18 who've had a major limb amputation at least a year ago and are experiencing significant residual or phantom limb pain. They should be in good health for surgery, not have had prior TMR or RPNI surgeries on the affected nerve, and must not be dealing with infections or certain mental disorders that could impact their participation.

What is being tested?

The study compares three surgical techniques to relieve postamputation pain: Targeted Muscle Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and standard neuroma treatment involving excision and muscle burying. It's a double-blind RCT where patients will be monitored for four years.

What are the potential side effects?

While specific side effects aren't listed, common risks of surgical procedures may include infection, bleeding, scarring, pain at the incision site, possible damage to surrounding tissues or nerves, and general anesthesia complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a major limb amputation.

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My average pain score is 4 or more on a scale of 0 to 10.

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I am 18 years old or older.

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It has been over a year since my last amputation.

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I stopped any non-drug pain treatments like electrical stimulation or mirror therapy over a month ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that affects nerve healing in the area needing treatment.

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I have an infection in the part of my limb that remains after amputation.

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I had surgery on a nerve for a painful growth after an amputation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to12-month post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to12-month post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to12-month post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Residual limb pain intensity

Secondary study objectives

Neuroma pain intensity

Phantom limb pain intensity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Targeted Muscle Reinnervation (TMR)Active Control1 Intervention

The surgical procedure comprises three steps: preparation of the donor nerve, identification of a motor branch to the targeted muscle, and nerve coaptation. To prepare the donor nerve, the surgeon will identify the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Next, the surgeon will identify a motor branch to a nearby target muscle and will confirm muscle contraction using a hand-held nerve stimulator. The motor branch to the target muscle will be transected as close as possible to its entry point without tension. In the final step, the previous nerve stump from which the neuroma was resected will be transferred and coapted to the newly severed motor branch that innervates the target muscle and secured by 2-3 non-resorbable monofilament sutures. The surgery time is approximately 2-3 hours and it takes place in the hospital.

Group II: Regenerative Peripheral Nerve Interface (RPNI)Active Control1 Intervention

The RPNI procedure involves construction of a residual peripheral nerve split into several nerve fascicles and implanted into free skeletal muscle grafts. First, the surgeon identifies the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Then, a longitudinal intraneural dissection will be performed exposing its fascicles. Next, autologous muscle grafts will be harvested from a healthy donor site, and the dissected nerve stumps will be placed parallel to the muscle fibers. The nerve stump will be secured to the muscle graft, thereafter the graft will be wrapped around the nerve stump and anchored in the folded graft, thus creating an RPNI. This will be repeated for each fascicle obtained from splitting the transected nerve. Lastly, the RPNIs will be placed in a protected area. The surgery time is approximately 2-3 hours and it takes place in the hospital.

Group III: Standard neuroma treatment, neuroma excision, and muscle buryingActive Control1 Intervention

The standard neuroma treatment, also called neuroma transposition, includes excision of the terminal neuroma and burying the nerve into an adjacent deep muscle.The standard neuroma treatment entails the excision of the terminal neuroma and then implanting the nerve into an adjacent muscle. Firstly, the surgeon will identify the nerve with a painful neuroma and thereafter resect the neuroma up to healthy fascicles. Next, the surgeon will identify a nearby muscle which is not involved in joint motion and has limited output opportunities for the nerve. The nerve will then be channeled at least 1 cm inside the muscle without applying any tension to it and secured by 1-2 non-resorbable monofilament sutures. The identified nerve with the painful neuroma will not be treated with any additional therapy than the resection (e.g., diathermy, pharmacotherapy, crushing, etc.). The surgery time is approximately 1-2 hours and it takes place in the hospital.

0 / 8Eligibility criteria met