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10 Participants NeededMy employer runs this trial

Surgical Technique for Amputation

Recruiting at 1 trial location
MJ
Overseen ByMatthew J Carty, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

In this study, the investigators are evaluating a new surgical technique that may allow participants to control their muscles in a new way after their amputation or revision surgery. The investigators are looking for people who have limb amputation or require a revision operation to a previous amputation. Participants must be over 18 and younger than 65, willing to begin participation within two weeks of their surgery, and be willing to travel regularly to Boston.

In this study, participants will have a modified revision procedure on their amputated limb or a modified amputation procedure, followed by a series of follow up visits in clinic and to a gait lab at Harvard. Participants will also use a wearable device on their limb at home to complete daily training tasks and games.

Who Is on the Research Team?

SS

Shriya Srinivasan, PhD

Principal Investigator

Harvard University

MJ

Matthew J Carty, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 65 who have had a limb amputated or need a revision surgery on an existing amputation. Participants must be able to start within two weeks of their surgery and travel regularly to Boston for follow-up visits.

Inclusion Criteria

Fluent in English
Demonstrate appropriate motivation and reliability to comply with scheduled training and evaluation sessions throughout the postoperative period
I am willing to do study activities at home.
See 5 more

Exclusion Criteria

Passive or active metal implants incompatible with EMG
Pacemakers, deep brain stimulators, or other electronic implantables
Active smoker
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • amputation or revision procedure with additional RPNI construction

Trial Overview

The study tests a new surgical technique called RPNI during amputation or revision, aiming to improve muscle control in the affected limb. After surgery, participants will do daily training at home with a wearable device and attend regular clinic and lab visits.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Surgical Intervention - RPNI ConstructionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Harvard University

Collaborator

Trials
237
Recruited
588,000+

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