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

NCT03882073 | Recruiting DMC

• 2 other identifiers: 2018p001893CDMRP-170384
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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 generation prosthetic devices and restore sensation and proprioception to the amputated limb. The investigators will test this hypothesis by performing modified above elbow or below elbow amputations in ten intervention patients, and compare their outcomes to ten control patients who have undergone tradition amputations at similar levels. The specific aims of the project are:

1. 1.To define a standardized approach to the performance of a novel operative procedure for both below elbow (BEA) and above elbow amputations (AEA)
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 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 BEA and AEA
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)

  0-36 months

• Motor Unit Excursion

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

  0-36 months

• Proprioception Recovery

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

  0-36 months

Secondary Outcomes (9)

• Infection Rate

  0-36 months

• Delayed Wound Healing Rate

  0-36 months

• Operative Revision Rate

  0-36 months

• Seroma Rate

  0-36 months

• Deep Vein Thrombosis Rate

  0-36 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Modified amputation procedure

Procedure: Modified amputation procedure

Control group

ACTIVE COMPARATOR

Standard amputation procedure

Procedure: Standard amputation procedure

Interventions

Modified amputation procedure PROCEDURE

A fishmouth incision will be made. Radial and ulnar (BEA) or humoral (AEA) osteotomies will be performed. Segments of the flexor carpi radialis (FCR), extensor carpi radialis longus (ECRL), flexor digitorum profundi (FDP), extensor digitorum communis (EDC), flexor pollicis longus (FPL) and extensor pollicis longus (EPL) will be isolated, as well as the biceps (B) and triceps (T) groups in the AEA 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. Sensory nerve endings of the distal median, ulnar and radial nerves will then be isolated and redirected to discrete skin patches in the proximal residual forearm or proximal brachium. Coaptation of the FCR/ECRL, FDP/EDC, FPL/EPL and B/T 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.

Intervention group

Standard amputation procedure PROCEDURE

Amputation is performed via standard techniques at either the BEA or AEA level. No construction of agonist-antagonist muscle pairs will be performed.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 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

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 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts Institute of Technology: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (4)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Massachusetts Institute of Technology Media Lab

Cambridge, Massachusetts, 02139, United States

RECRUITING

Related Publications (12)

• 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

• Biddiss EA, Chau TT. Upper limb prosthesis use and abandonment: a survey of the last 25 years. Prosthet Orthot Int. 2007 Sep;31(3):236-57. doi: 10.1080/03093640600994581.

  PMID: 17979010 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

• Clites TR, Carty MJ, Srinivasan S, Zorzos AN, Herr HM. A murine model of a novel surgical architecture for proprioceptive muscle feedback and its potential application to control of advanced limb prostheses. J Neural Eng. 2017 Jun;14(3):036002. doi: 10.1088/1741-2552/aa614b. Epub 2017 Feb 17.

  PMID: 28211795 BACKGROUND

• Clites TR, Carty MJ, Ullauri JB, Carney ME, Mooney LM, Duval JF, Srinivasan SS, Herr HM. Proprioception from a neurally controlled lower-extremity prosthesis. Sci Transl Med. 2018 May 30;10(443):eaap8373. doi: 10.1126/scitranslmed.aap8373.

  PMID: 29848665 BACKGROUND

• Taghipour H, Moharamzad Y, Mafi AR, Amini A, Naghizadeh MM, Soroush MR, Namavari A. Quality of life among veterans with war-related unilateral lower extremity amputation: a long-term survey in a prosthesis center in Iran. J Orthop Trauma. 2009 Aug;23(7):525-30. doi: 10.1097/BOT.0b013e3181a10241.

  PMID: 19633463 BACKGROUND

• Lipsitz SR, Fitzmaurice GM, Orav EJ, Laird NM. Performance of generalized estimating equations in practical situations. Biometrics. 1994 Mar;50(1):270-8.

  PMID: 8086610 BACKGROUND

Study Officials

• Matthew J Carty, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew J Carty, MD

CONTACT

6179834555; mcarty@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Lower Extremity Transplant Program

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: May 1, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)