A new method for upper limb amputation to improve control and sensation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to redesign upper limb amputation procedures to enhance volitional control of advanced prosthetic devices and restore proprioception in amputated limbs. The study will involve modified above elbow and below elbow amputations in ten patients, comparing their outcomes with ten control patients who undergo traditional amputations. The specific goals include establishing a standardized surgical approach, measuring motor activation in the residual limb, and assessing the extent of proprioceptive feedback achieved through the new technique.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Must demonstrate sufficiently sound health to undergo the operative procedure, including adequate cardiopulmonary stability to undergo general anesthesia (specifically, American Society of Anesthesiology Class I or II)
* Must have intact inherent wound healing capacity
* Must demonstrate adequate communication skills to convey the status of their sensorimotor recovery throughout the postoperative phase,
* Must exhibit proper level of motivation to comply with postoperative follow up requirements
* Must be willing to also consent to study activities taking place at Massachusetts Institute of Technology (approved under same IRB protocol via ceded IRB review) as some outcome measures will be assessed at that site

Exclusion Criteria:

* Patients beyond the stated age restrictions
* Those with severe illness rendering them unable to undergo the operative procedure safely (e.g., unresolved sepsis or cardiopulmonary instability manifest as documented coronary artery disease and/or chronic obstructive pulmonary disease)
* Patients with active infections, particularly deep infections in the arm to be amputated
* Patients who are taking immunosuppressive agents
* Patients with impairment in inherent wound healing pathways, such as those with primary connective tissue disorders or those on chronic steroid therapy
* Patients with extensive peripheral neuropathies (diabetic or otherwise) that would potentially inhibit appropriate reinnervation of the surgical constructs
* Active smokers; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively
* Patients who are unable to provide informed consent and those with a demonstrated history of poor compliance
* Pregnant women will not be considered due to the potential risks of general anesthesia

Patients will not be excluded from participation in the study on the grounds of minority status, religious status, race or gender. Non-English speaking patients will not be excluded from the study; interpreters will be made available to them for translation of both verbal interactions and written documents.

Where it's running

• Walter Reed National Military Medical Center
  Bethesda, Maryland, United States Recruiting
• Brigham & Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Massachusetts Institute of Technology Media Lab
  Cambridge, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Matthew J Carty, MD — Brigham and Women's Hospital
• Study coordinator: Matthew J Carty, MD
• Email: mcarty@partners.org
• Phone: 6179834555

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.