Status:

RECRUITING

A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception

Lead Sponsor:

Brigham and Women's Hospital

Collaborating Sponsors:

Massachusetts Institute of Technology

Walter Reed Army Institute of Research (WRAIR)

Conditions:

Amputation

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generati...

Detailed Description

Upper extremity amputation is among the oldest known surgical procedures in medical history, with many of its technical principles having first been elucidated by Hippocrates. Despite the passage of m...

Eligibility Criteria

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.

Key Trial Info

Start Date :

May 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2026

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT03882073

Start Date

May 1 2019

End Date

September 30 2026

Last Update

October 20 2025

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

2

Brigham & Women's Hospital

Boston, Massachusetts, United States, 02114

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

4

Massachusetts Institute of Technology Media Lab

Cambridge, Massachusetts, United States, 02139

A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception | DecenTrialz