What side effects are associated with this type of intervention?

Common treatments for amputation, especially those aiming to enhance volitional control and proprioception, include surgical techniques, prosthetic fitting, and rehabilitation therapies. Known side effects of these treatments can include phantom limb pain, infection at the surgical site, neuroma formation, and issues related to prosthetic use such as skin irritation and pressure sores. Additionally, patients may experience psychological effects such as depression and anxiety. The modified amputation technique being studied aims to improve outcomes by potentially reducing some of these side effects, particularly by enhancing motor control and sensory feedback.

What prior FDA approvals exist?

The FDA has approved various treatments for amputation, primarily focusing on prosthetic devices and pain management. Advanced prosthetic limbs, such as myoelectric prostheses, have been approved to enhance volitional control by using electrical signals from the residual limb muscles. Additionally, medications like gabapentin and pregabalin are approved for managing neuropathic pain associated with amputation. While the novel surgical approach to amputation aimed at enhancing volitional control and proprioception is still under investigation, these existing treatments provide significant benefits to amputees.

What other types of research exist?

Promising novel alternatives to the Modified Amputation Technique for amputation patients include Brain-Computer Interface (BCI) controlled prostheses, which offer advanced control over prosthetic devices through direct neural input. Additionally, advancements in deep brain stimulation (DBS) and selective dorsal rhizotomy (SDR) for managing motor control issues in conditions like cerebral palsy may offer insights into improving motor function and proprioception in amputation patients. These techniques focus on enhancing neural integration and sensory feedback, potentially providing significant improvements in prosthetic control and user experience.

← Back to Search

Procedure

Modified vs Standard Procedures for Amputation

N/A

Recruiting

Led By Matthew J Carty, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

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

Must have

Males or females between the ages of 18 and 65

Candidates for elective unilateral or bilateral upper extremity amputation at either the above elbow or below elbow level due to traumatic injury, congenital limb deformities or progressive arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new surgical method for arm amputations to improve the use of advanced prosthetic limbs. It targets patients needing above or below elbow amputations. The technique uses remaining muscles to create natural movement and sensation, enhancing control and feedback with prosthetics. A method that directly attaches a prosthesis to the bone has been developed to improve prosthetic function and user experience.

Who is the study for?

This trial is for adults aged 18-65 who need an arm amputation due to injury, birth defects, or arthritis. They must be healthy enough for surgery under general anesthesia and motivated to follow up post-surgery. Good communication skills are required as they'll report on their recovery.

What is being tested?

The study tests a new way of performing arm amputations aimed at improving control over advanced prosthetics and restoring sensation. Ten patients will receive this modified procedure and their results will be compared with ten receiving traditional amputations.

What are the potential side effects?

While specific side effects aren't listed, potential risks may include those typical of surgical procedures such as pain, infection risk at the surgery site, issues with wound healing, and possible adverse reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 65 years old.

Select...

I am a candidate for arm amputation due to injury, birth defects, or worsening arthritis.

Select...

My body can heal wounds normally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Motor Unit Excursion

Motor Unit Innervation

Proprioception Recovery

Secondary study objectives

30-Day Mortality Rate

Deep Vein Thrombosis Rate

Delayed Wound Healing Rate

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Modified amputation procedure

Group II: Control groupActive Control1 Intervention

Standard amputation procedure

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The modified amputation technique aims to enhance volitional control and restore proprioception in amputated limbs. This is achieved by redesigning the surgical approach to preserve and optimize the residual limb's motor and sensory functions. By maintaining more of the limb's original muscle and nerve structures, patients can achieve better control over next-generation prosthetic devices, allowing for more natural and precise movements. Additionally, the technique aims to restore proprioceptive feedback, which helps patients sense the position and movement of their prosthetic limb, improving balance and coordination. These advancements are crucial as they significantly enhance the functional outcomes and quality of life for amputation patients.

Interventions to Improve Movement and Functional Outcomes in Adult Stroke Rehabilitation: Review and Evidence Summary.Sensory impairments of the lower limb after stroke: a pooled analysis of individual patient data.