Targeted Muscle Reinnervation for Amputees

(TMR Trial)

Overseen By Anna Valencia, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Joshua Hustedt

Disqualifiers: Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping individuals who need a leg amputation by testing a technique called targeted muscle reinnervation (TMR). TMR aims to improve outcomes by connecting nerves to new muscles, potentially reducing pain and enhancing function. Participants will be randomly assigned to receive either the traditional amputation procedure or the one with TMR. Individuals indicated for a leg amputation at Banner-University Medical Center Phoenix may be suitable candidates for this study. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance future amputation procedures.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that targeted muscle reinnervation is safe for amputees?

Research has shown that targeted muscle reinnervation (TMR) is generally safe for individuals with amputations. A review of studies found that more than half of those who underwent TMR experienced lasting pain relief, suggesting its effectiveness without major complications. Another study found that TMR often leads to better outcomes compared to standard amputation, indicating that patients not only tolerate TMR well but also benefit from it. While some patients may experience mild side effects, serious issues are rare. These findings offer a positive perspective on the safety of TMR. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Targeted Muscle Reinnervation (TMR) for amputees because it offers a new approach to managing nerve pain and improving prosthetic control. Unlike traditional amputation procedures that simply cut and seal nerves, TMR reroutes these severed nerves to new muscle targets, allowing them to "reconnect" with muscles using advanced microsurgical techniques. This innovative method can potentially reduce phantom limb pain and enhance the functionality of prosthetic limbs, offering amputees a more integrated and natural feeling with their prosthetics.

What evidence suggests that targeted muscle reinnervation is effective for amputees?

Research has shown that targeted muscle reinnervation (TMR), which participants in this trial may receive, benefits people who have had amputations. In one study, 86.2% of patients experienced relief from nerve pain after undergoing TMR. This procedure redirects nerves to new muscle areas, reducing pain and aiding recovery. Reviews of multiple studies confirm that TMR reduces pain more effectively than standard treatments. Overall, TMR shows promise in improving the quality of life for amputees by effectively managing pain. ^{1 2 3 6 7}

Who Is on the Research Team?

Joshua Hustedt, MD, MHS

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a below knee or above knee amputation at Banner-University Medical Center Phoenix. It's not open to those who don't meet these requirements.

Inclusion Criteria

I am 18 or older and need a leg amputation.

Exclusion Criteria

Any individual who does not meet inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants undergo pre-operative assessments and preparation for amputation with or without TMR

4 weeks

Surgery

Participants undergo amputation surgery with or without the TMR procedure

1 week

Post-operative Treatment

Participants receive post-operative care and monitoring, including pain management and rehabilitation

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on phantom limb and neuroma pain

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Targeted Muscle Reinnervation

Trial Overview The study is testing the effectiveness of targeted muscle reinnervation (TMR) in improving outcomes for amputees. Participants will be randomly assigned to receive TMR or not during their amputation surgery.

How Is the Trial Designed?

Group I: Amputation with TMR Experimental Treatment 1 Intervention

Amputation will follow standard procedure, but with the addition of the TMR procedure, which involves rerouting severed or injured nerves to new muscle targets using microsurgical techniques to provide the nerve endings with a new muscle to innervate.

Group II: Amputation without TMR (SOC) Active Control 1 Intervention

A traditional amputation follows the normal standard of care, with transection of peripheral nerves.

Who Is Running the Clinical Trial?

Joshua Hustedt

Lead Sponsor

Trials

1

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9512320/

Targeted Muscle Reinnervation for Trauma-Related ... Following TMR for trauma-related amputation, most patients experienced neuroma pain resolution (86.2%, 95% confidence interval [CI]: 67.2-95.0%) ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681524001670

Review The effectiveness of targeted muscle reinnervation ... The systematic review underscores TMR's potential benefits in alleviating pain, fostering post-amputation rehabilitation and enhancing overall well-being for ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05408520

NCT05408520 | Targeted Muscle Reinnervation Study (TMR) The purpose of this study is to examine the effect of targeted muscle reinnervation on the outcomes of amputees at a level 1 trauma center.

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000211060

A Systematic Review and Meta-analysis (P5-7.001) Conclusions: This meta-analysis demonstrates that TMR and RPNI significantly reduce PLP and RLP compared to standard treatment, enhancing pain ...

5. f1000research.com f1000research.com/articles/13-1435

Evaluating the Efficacy of Targeted Muscle Reinnervation ... The outcomes consistently suggest that TMR and other nerve-related interventions offer promising improvements in reducing pain and enhancing ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681524004273

Targeted muscle reinnervation at the time of amputation to ... This study demonstrates that more than half of all patients undergoing primary TMR achieved sustained pain prophylaxis, and approximately a quarter of patients ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11559798/

Targeted Muscle Reinnervation Compared to Standard ... This systematic review and meta-analysis aims to compare patient-reported and functional outcomes following amputation with either TMR or standard neurological ...