Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations

NCT03374319 | Completed DMC

• 2 other identifiers: 2014p001379CDMRP-160165
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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 successful employment of next generation lower extremity prostheses. The specific aims of the project are as follows:

1. 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. 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. 3.To describe the extent of proprioceptive and other sensory feedback achievable through the employment of these modified surgical techniques
4. 4.To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BKA and AKA
5. 5.To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

Conditions

Amputation

Outcome Measures

Primary Outcomes (3)

• Motor Unit Innervation

  Intact volitional activation of motor constructs, as assessed by electromyographic evidence of activation (muscle potentials measured in mV)

  0-48 months

• Motor Unit Excursion

  Intact volitional activation of motor constructs with measurable excursion, as assessed by ultrasound (excursion measured in mm)

  0-48 months

• Proprioception Recovery

  Manifestation of functional proprioception with motor unit activation, as evidenced by spatial limb position testing using a modified lower limb prosthesis (accurate limb positioning relative to target measured in mm)

  0-48 months

Secondary Outcomes (6)

• Infection Rate

  0-48 months

• Delayed Wound Healing Rate

  0-48 months

• Operative Revision Rate

  0-48 months

• Seroma Rate

  0-48 months

• Deep Vein Thrombosis Rate

  0-48 months

Study Arms (1)

Intervention group

EXPERIMENTAL

Modified amputation procedure

Procedure: Modified amputation procedure

Interventions

Modified amputation procedure PROCEDURE

A stair-step (BKA) or fishmouth (AKA) incision will be made. Tibial and fibular or femoral osteotomies will be performed. Segments of the tibialis anterior (TA), peroneus longus (PL), lateral gastrocnemius (LG) and tibialis posterior (TP) muscles will be isolated, as well as the quadriceps (Q) and hamstring (H) groups in the AKA model; if it is not possible to preserve native innervation to these muscles, functional motor units will be constructed from muscle coapted to the appropriate motor nerve endings. The distal tibial and peroneal nerves will be redirected to skin patches in the distal or proximal thigh. Coaptation of the TA/LG, PL/TP and Q/H muscles will then be performed to promote dynamic coupling of these agonist/antagonist pairs. The skin envelope will then be closed in layers over percutaneous drains.

Also known as: Ewing, AMI, agonist-antagonist myoneural interface

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts Institute of Technology: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Brigham & Women's Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts Institute of Technology Media Lab

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (11)

• Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.

  PMID: 18295618 BACKGROUND

• Waters RL, Perry J, Antonelli D, Hislop H. Energy cost of walking of amputees: the influence of level of amputation. J Bone Joint Surg Am. 1976 Jan;58(1):42-6.

  PMID: 1249111 BACKGROUND

• Herr HM, Grabowski AM. Bionic ankle-foot prosthesis normalizes walking gait for persons with leg amputation. Proc Biol Sci. 2012 Feb 7;279(1728):457-64. doi: 10.1098/rspb.2011.1194. Epub 2011 Jul 13.

  PMID: 21752817 BACKGROUND

• Schultz AE, Kuiken TA. Neural interfaces for control of upper limb prostheses: the state of the art and future possibilities. PM R. 2011 Jan;3(1):55-67. doi: 10.1016/j.pmrj.2010.06.016.

  PMID: 21257135 BACKGROUND

• Shih JJ, Krusienski DJ, Wolpaw JR. Brain-computer interfaces in medicine. Mayo Clin Proc. 2012 Mar;87(3):268-79. doi: 10.1016/j.mayocp.2011.12.008. Epub 2012 Feb 10.

  PMID: 22325364 BACKGROUND

• Kung TA, Bueno RA, Alkhalefah GK, Langhals NB, Urbanchek MG, Cederna PS. Innovations in prosthetic interfaces for the upper extremity. Plast Reconstr Surg. 2013 Dec;132(6):1515-1523. doi: 10.1097/PRS.0b013e3182a97e5f.

  PMID: 24281580 BACKGROUND

• Navarro X, Krueger TB, Lago N, Micera S, Stieglitz T, Dario P. A critical review of interfaces with the peripheral nervous system for the control of neuroprostheses and hybrid bionic systems. J Peripher Nerv Syst. 2005 Sep;10(3):229-58. doi: 10.1111/j.1085-9489.2005.10303.x.

  PMID: 16221284 BACKGROUND

• Dumanian GA, Ko JH, O'Shaughnessy KD, Kim PS, Wilson CJ, Kuiken TA. Targeted reinnervation for transhumeral amputees: current surgical technique and update on results. Plast Reconstr Surg. 2009 Sep;124(3):863-869. doi: 10.1097/PRS.0b013e3181b038c9.

  PMID: 19730305 BACKGROUND

• Kuiken TA, Li G, Lock BA, Lipschutz RD, Miller LA, Stubblefield KA, Englehart KB. Targeted muscle reinnervation for real-time myoelectric control of multifunction artificial arms. JAMA. 2009 Feb 11;301(6):619-28. doi: 10.1001/jama.2009.116.

  PMID: 19211469 BACKGROUND

• Li YG, Chen XJ, Zhang YZ, Han DZ, Yan DX, Gao GZ, Zhao XC, Sun WJ. Three-dimensional digitalized virtual planning for retrograde sural neurovascular island flaps: a comparative study. Burns. 2014 Aug;40(5):974-80. doi: 10.1016/j.burns.2013.10.009. Epub 2013 Nov 26.

  PMID: 24290858 BACKGROUND

• Srinivasan SS, Gutierrez-Arango S, Teng AC, Israel E, Song H, Bailey ZK, Carty MJ, Freed LE, Herr HM. Neural interfacing architecture enables enhanced motor control and residual limb functionality postamputation. Proc Natl Acad Sci U S A. 2021 Mar 2;118(9):e2019555118. doi: 10.1073/pnas.2019555118.

  PMID: 33593940 DERIVED

Study Officials

• Matthew J Carty, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: December 15, 2017
• Study Start: September 15, 2017
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)