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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 belowSelect...
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
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 moreAwards & 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
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.
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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalOTHER
3,026 Previous Clinical Trials
13,413,779 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,246 Total Patients Enrolled
Massachusetts Institute of TechnologyOTHER
101 Previous Clinical Trials
12,822,005 Total Patients Enrolled
Walter Reed Army Institute of Research (WRAIR)FED
107 Previous Clinical Trials
36,754 Total Patients Enrolled
Matthew J Carty, MDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
83 Total Patients Enrolled