Powered Prosthesis for Amputation

Overseen By Suzanne Finucane, MS, PTA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Cognitive impairment, Visually impaired, Smoking, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

6 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate functional mobility, control, and user satisfaction from persons who have an amputation above the knee and have received osseo-integration (OI) and targeted muscle reinnervation (TMR) surgery, while walking with a powered knee and ankle prosthesis.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Powered Prosthesis for Amputation?

Research shows that targeted muscle reinnervation (TMR) can reduce post-amputation pain and improve the control of prosthetic limbs by using nerves from the amputated limb, which may enhance the quality of life for amputees. ^{1 2 3 4 5}

Is targeted muscle reinnervation (TMR) safe for use in humans?

Research on targeted muscle reinnervation (TMR) shows it is generally safe and can help reduce pain after amputation, improve prosthetic control, and enhance quality of life. However, it requires careful patient selection and specific rehabilitation therapy. ^{1 2 3 6 7}

How is the Powered Prosthesis for Amputation treatment different from other treatments?

This treatment is unique because it combines Osseointegration (OI), which involves directly attaching a prosthesis to the bone, with Targeted Muscle Reinnervation (TMR), a surgical technique that reroutes nerves to improve control of myoelectric prostheses. This combination allows for more intuitive and effective use of advanced prosthetic limbs compared to traditional methods. ^{1 5 6 7 8}

Research Team

Levi Hargrove, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

This trial is for individuals aged 18-70 with an above-knee amputation who currently use a prosthesis and can safely operate it. They must be able to walk at various levels (K2/K3/K4), produce detectable muscle signals, and either are candidates for or have had osseointegration (OI) and targeted muscle reinnervation (TMR) surgeries.

Inclusion Criteria

I am a candidate for or have had orthopedic implant surgery.

Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes

I am a candidate for or have had TMR surgery as confirmed by my surgical team.

Exclusion Criteria

I cannot have certain bone and nerve integration surgeries.

Significant comorbidity that would preclude completion of the study, use of prostheses, or would otherwise prevent data acquisition by researchers

I understand and can follow the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Fitting and Training

Participants are fit for a custom instrumented socket and trained on using the powered prosthesis. EMG data are collected for pattern recognition control system training.

10-12 weeks

Up to 10 visits (in-person)

OI and TMR Surgery and Recovery

Participants undergo osseointegration and targeted muscle reinnervation surgeries, followed by recovery.

12 weeks

Post-Surgery Fitting and Training

Participants are fit with the powered prosthesis using the OI interface and trained on its use. Functional, metabolic, and biomechanical benefits are evaluated.

10-12 weeks

Up to 10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of mobility, balance, and user satisfaction.

1 year

Treatment Details

Interventions

• Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR)
• Powered Prosthesis Training and EMG data collection

Trial Overview The study tests how well people with above-knee amputations can move, control, and feel satisfied using a powered knee and ankle prosthesis after receiving OI and TMR surgeries. It involves training on the new prosthesis as well as collecting muscle activity data.

Participant Groups

Group I: Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration Recipients Experimental Treatment 2 Interventions

Perform Osseointegration (OI)Surgery and Targeted Muscle Reinnervation (TMR) and evaluate powered prosthesis training and use. The participant will complete non-weightbearing neural control tasks along with functional, biomechanical, metabolic and qualitative patient-reported outcome measures using the OI interface and the powered leg prosthesis.

Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR) is already approved in United States, European Union for the following indications:

Approved in United States as Osseointegration Limb Replacement for:

• Upper limb amputations
• Lower limb amputations
• Transtibial amputations
• Transhumeral amputations

Approved in European Union as Osseointegration Limb Replacement for:

• Upper limb amputations
• Lower limb amputations

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Northwestern Memorial Hospital

Collaborator

Trials

42

Recruited

15,800+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Findings from Research

Targeted muscle reinnervation (TMR) surgery enhances the control of intelligent prosthetics by reconstructing the neural pathways that connect the brain to the muscles, allowing for more intuitive movement in amputees.

TMR has been recognized internationally as a groundbreaking approach to improve prosthetic function, and it holds the potential to significantly benefit the estimated 2 million amputees in China by providing a new standard of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Targeted muscle reinnervation: a surgical technique of human-machine interface for intelligent prosthesis]. Guo, Y., Zhao, W., Huang, J., et al.[2023]

Targeted muscle reinnervation (TMR) is effective in reducing phantom limb pain (PLP) and residual limb pain (RLP) in lower extremity amputees, based on a systematic review of 11 studies involving 318 patients.

The procedure has a low complication rate, with postoperative neuroma being the most common issue reported in only 7.2% of cases, indicating that TMR is a safe option for managing pain after amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of targeted muscle reinnervation in lower extremity amputations: A systematic review. Berger, LE., Shin, S., Haffner, ZK., et al.[2023]

Combining targeted muscle reinnervation (TMR) with regenerative peripheral nerve interface (RPNI) techniques (TMRpni) in a patient with a left above-the-knee amputation resulted in reduced phantom and nerve pain.

This innovative approach may enhance the quality of life for amputee patients as the technique gains wider acceptance and understanding in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined TMR and RPNI in a vasculopathy patient: A case report. Galbraith, LG., Najafali, D., Gatherwright, JR.[2023]

Targeted muscle reinnervation (TMR) can significantly improve the control of myoelectric prostheses for amputees, but its application is still limited for lower extremity amputations and neuroma reconstruction.

A systematic review of 17 studies has identified common trends in nerve transfers and target muscle selections for TMR, which can aid in simplifying surgical decision-making and enhance the integration of TMR into reconstructive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demystifying Targeted Muscle Reinnervation: A Systematic Review of Nerve Transfers for the Lower Extremity. Henderson, JT., Koenig, ZA., Climov, M., et al.[2023]

The study identified the locations and number of motor end plates for key muscles used in targeted muscle reinnervation (TMR) in the upper arm, based on dissections of 18 cadaver limbs, which can enhance prosthetic control for amputees.

Reliable anatomical landmarks were established for the medial biceps, brachialis, and lateral triceps, which can help surgeons accurately locate nerve branches during TMR procedures, potentially improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Muscle Reinnervation of the Brachium: An Anatomic Study of Musculocutaneous and Radial Nerve Motor Points Relative to Proximal Landmarks. Renninger, CH., Rocchi, VJ., Kroonen, LT.[2022]

Targeted muscle reinnervation (TMR) successfully increased the number of EMG signals available for controlling myoelectric prostheses in seven patients, enhancing their ability to perform movements from an average of 1-2 signals pre-surgery to 3-5 signals post-surgery.

Post-TMR, six out of seven patients achieved six degrees of freedom in prosthesis control without needing co-contraction to switch functions, indicating a significant improvement in intuitive control and functionality with no major surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted muscle reinnervation to improve electromyography signals for advanced myoelectric prosthetic limbs: a series of seven patients. Myers, H., Lu, D., Gray, SJ., et al.[2021]

Targeted Muscle Reinnervation (TMR) enhances control of myoelectric prostheses for above-elbow amputees by allowing for more independent muscle signal activation through nerve re-routing, but it requires careful patient selection and a specific rehabilitation protocol.

The rehabilitation protocol includes pre-surgery assessments and post-surgery interventions focusing on pain control, muscle training, and functional assessments, ensuring effective integration of the prosthesis and optimizing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy Interventions for Upper Limb Amputees Undergoing Selective Nerve Transfers. Sturma, A., Hruby, LA., Boesendorfer, A., et al.[2022]

Targeted muscle reinnervation (TMR) allows patients with upper-limb amputations to control prosthetic arms using EMG signals from reinnervated muscles, demonstrating a high success rate of 96.3% for elbow and wrist movements.

Patients who underwent TMR surgery were able to perform various arm movements with a virtual prosthetic arm, showing that reinnervated muscles can effectively provide the necessary neural control for advanced prosthetic devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted muscle reinnervation for real-time myoelectric control of multifunction artificial arms. Kuiken, TA., Li, G., Lock, BA., et al.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

[Targeted muscle reinnervation: a surgical technique of human-machine interface for intelligent prosthesis]. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The application of targeted muscle reinnervation in lower extremity amputations: A systematic review. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Combined TMR and RPNI in a vasculopathy patient: A case report. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Demystifying Targeted Muscle Reinnervation: A Systematic Review of Nerve Transfers for the Lower Extremity. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Targeted Muscle Reinnervation of the Brachium: An Anatomic Study of Musculocutaneous and Radial Nerve Motor Points Relative to Proximal Landmarks. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Targeted muscle reinnervation to improve electromyography signals for advanced myoelectric prosthetic limbs: a series of seven patients. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Therapy Interventions for Upper Limb Amputees Undergoing Selective Nerve Transfers. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Targeted muscle reinnervation for real-time myoelectric control of multifunction artificial arms. [2022]