Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations

Completed · Not applicable

Conditions studied: Amputation

In brief

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 successful employment of next generation lower extremity prostheses. The specific aims of the project are as follows: 1. To define a standardized approach to the performance of a novel operative procedure for both below knee (BKA) and above knee (AKA) amputations 2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs 3. To describe the extent of proprioceptive and other sensory feedback achievable through the employment of these modified surgical techniques 4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BKA and AKA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

Key facts

Study ID: NCT03374319
Run by: Brigham and Women's Hospital
People needed: 50
Starts: 2017-09-15
Expected to finish: 2024-09-30
Last updated by the study team: 2025-10-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Brigham & Women's Hospital — Boston, Massachusetts, United States
Massachusetts Institute of Technology Media Lab — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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