Status:
COMPLETED
Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Massachusetts Institute of Technology
Massachusetts General Hospital
Conditions:
Amputation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The hypothesis of this research protocol is that we will be able to redesign the manner in which lower limb amputations are performed so as to include biological actuators that will enable the success...
Detailed Description
Historical Background Lower extremity amputation is among the oldest known surgical procedures in medical history. Despite the passage of over two millennia, however, relatively little has changed in...
Eligibility Criteria
Inclusion
- Males or females between the ages of 18 and 65
- Candidates for elective unilateral or bilateral lower extremity amputation at either the above knee or below knee 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.
Exclusion
- 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 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 :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03374319
Start Date
September 15 2017
End Date
September 30 2024
Last Update
October 17 2025
Active Locations (2)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02114
2
Massachusetts Institute of Technology Media Lab
Cambridge, Massachusetts, United States, 02139