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Clinical Trials/NCT03374319
NCT03374319CompletedNot Applicable

Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations

Brigham and Women's Hospital2 sites in 1 country50 target enrollmentStarted: September 15, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
Motor Unit Innervation

Study Overview

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. 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

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 the operative approach. Currently, lower limb amputation is indicated most frequently for lower extremity compromise due to severe peripheral vascular disease, followed in short order by trauma, tumors, infections and congenital limb deficiencies. Estimates of frequency of lower limb amputations range from 30,000-40,000 cases per year in the United States alone.

Normal function of the lower limb is enabled through the interplay of multiple muscle groups acting in concert. Ambulation is a remarkably orchestrated biomechanical process that is dependent upon a complex feedback loop involving the central and peripheral nervous systems and the musculoskeletal system. In their native state, the muscles of the lower extremity exist in a balanced agonist/antagonist milieu in which volitional activation of one muscle leads not only to its contracture, but also passive stretch of its opposite. Changes in muscle tension manifest through these changes lead to stimulation of specialized receptors within the muscle fibers that transmit joint position information to the cerebral cortex. Such feedback, in conjunction with cutaneous sensory information from skin mechanoreceptors, provides us with a sense of limb proprioception that ultimately enables high fidelity limb control, even in the absence of visual feedback.

However, the standard operative approach to lower limb amputation at either the below knee (BKA) or above knee (AKA) level obliterates many of the dynamic relationships characteristic of the uninjured lower extremity. Initial exposure is accomplished through either a stair-step (BKA) or fishmouth (AKA) pattern incision, followed by progressive transection of muscles, vessels, nerves and bone at the level of the incision. Tissues distal to the site of structural transection are discarded, regardless of whether or not there may be viable segments, and the proximal residual muscles are layered over the distal transected bone in order to provide insulation to this exposed osseous surface. The surrounding skin is then advanced over the bone/muscle infrastructure in order to achieve definitive closure. The rudimentary approximation of tissues in the distal limb in these approaches results in a disorganized scar mass in which normal dynamic muscle relationships are destroyed. The uncoupling of native agonist/antagonist muscle pairings results in isometric contraction of residual muscle groups upon volitional activation, producing incomplete, unbalanced neural feedback to the brain that results in aberrant perception of residual limb position. Such disturbed feedback not only results in impaired ambulatory function with prosthetics, but also manifests as pathological sensory perception of the extremity in the form of phantom limb and phantom pain symptomatology.

To date, providers and patients have tolerated the limitations of these approaches due to the fairly simplistic goal of lower limb amputation: to provide a stable, padded surface for prosthesis mounting. Historically, lower limb prostheses have afforded amputees the opportunity to recover at least some measure of ambulatory function. Standard lower limb prostheses currently afford the wearer the walk in a rudimentary fashion, as well as occasionally run. However, such devices have generally not been able to recapitulate the complex biomechanics of the human lower limb due to limited ranges of motion and lack of feedback control. These limitations have resulted in substantially altered kinematics in lower limb amputees that are associated with derangements in energy expenditure profiles that worsen with laterality and ascending level.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 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 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.

Arms & Interventions

Intervention group

Experimental

Modified amputation procedure

Intervention: Modified amputation procedure (Procedure)

Outcomes

Primary Outcomes

Motor Unit Innervation

Time Frame: 0-48 months

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

Motor Unit Excursion

Time Frame: 0-48 months

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

Proprioception Recovery

Time Frame: 0-48 months

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)

Secondary Outcomes

  • 30-Day Mortality Rate(0-48 months)
  • Seroma Rate(0-48 months)
  • Deep Vein Thrombosis Rate(0-48 months)
  • Delayed Wound Healing Rate(0-48 months)
  • Infection Rate(0-48 months)
  • Operative Revision Rate(0-48 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Matthew Carty

Staff Surgeon

Brigham and Women's Hospital

Study Sites (2)

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