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Procedure

Intervention group 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

Study Summary

This trial aims to improve upper limb amputation procedures to enable better control of prosthetics and restore sensation/proprioception. 10 patients will have modified amputations compared to 10 control patients with traditional amputations.

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.Check my eligibility
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.See study design
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
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I am between 18 and 65 years old.
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I am a candidate for arm amputation due to injury, birth defects, or worsening arthritis.
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My body can heal wounds normally.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Motor Unit Excursion
Motor Unit Innervation
Proprioception Recovery
Secondary outcome measures
30-Day Mortality Rate
Deep Vein Thrombosis Rate
Delayed Wound Healing Rate
+6 more

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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
2,933 Previous Clinical Trials
13,198,461 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,810 Total Patients Enrolled
Massachusetts Institute of TechnologyOTHER
97 Previous Clinical Trials
12,729,967 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
JamaJournal
Targeted Muscle Reinnervation for Real-time Myoelectric Control of Multifunction Artificial Arms
Kuiken, Todd A.. 2009. “Targeted Muscle Reinnervation for Real-time Myoelectric Control of Multifunction Artificial Arms”. Jama. American Medical Association (AMA). doi:10.1001/jama.2009.116.
Plastic and Reconstructive SurgeryJournal
Targeted Reinnervation for Transhumeral Amputees: Current Surgical Technique and Update on Results
Dumanian, Gregory A., Jason H. Ko, Kristina D. O’Shaughnessy, Peter S. Kim, Christopher J. Wilson, and Todd A. Kuiken. 2009. “Targeted Reinnervation for Transhumeral Amputees: Current Surgical Technique and Update on Results”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/prs.0b013e3181b038c9.
Plastic and Reconstructive SurgeryJournal
Innovations in Prosthetic Interfaces for the Upper Extremity
Kung, Theodore A., Reuben A. Bueno, Ghadah K. Alkhalefah, Nicholas B. Langhals, Melanie G. Urbanchek, and Paul S. Cederna. 2013. “Innovations in Prosthetic Interfaces for the Upper Extremity”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/prs.0b013e3182a97e5f.
Journal of the Peripheral Nervous SystemJournal
A Critical Review of Interfaces with the Peripheral Nervous System for the Control of Neuroprostheses and Hybrid Bionic Systems
Navarro, Xavier, Thilo B. Krueger, Natalia Lago, Silvestro Micera, Thomas Stieglitz, and Paolo Dario. 2005. “A Critical Review of Interfaces with the Peripheral Nervous System for the Control of Neuroprostheses and Hybrid Bionic Systems”. Journal of the Peripheral Nervous System. Wiley. doi:10.1111/j.1085-9489.2005.10303.x.
~2 spots leftby Sep 2024
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