跳至主要内容
临床试验/NCT03882073
NCT03882073招募中不适用

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

Brigham and Women's Hospital8 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
8
主要终点
Proprioception Recovery

研究概览

简要总结

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. To define a standardized approach to the performance of a novel operative procedure for both below elbow (BEA) and above elbow amputations (AEA)
  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 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 BEA and AEA
  5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

This will be a phase I/pilot clinical trial to be performed over a three-year period as a collaborative initiative involving Brigham & Women's Hospital/Brigham & Women's Faulkner Hospital (BWH/BWFH), Walter Reed National Military Medical Center (WRNMMC), and the Massachusetts Institute of Technology (MIT). The investigators will plan to perform 6 of the 10 amputations at BWH/BWFH, and 4 of the amputations at WRNMMC.

详细描述

Upper extremity amputation is among the oldest known surgical procedures in medical history, with many of its technical principles having first been elucidated by Hippocrates. Despite the passage of more than two millennia, relatively little has changed in the operative approach to upper limb sacrifice. An estimated 58,000 patients in the United States currently suffer from upper extremity limb loss at either the above elbow (AEA) or below elbow (BEA) level, and the prevalence of upper limb amputation is expected to rise to approximately 95,000 patients by 2050.

Normal function of the upper limb is enabled through the dynamic interplay of multiple muscle groups acting in concert. Manual dexterity 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 upper extremity exist in a balanced agonist/antagonist situation in which volitional activation of one muscle leads not only to its contracture, but also to passive stretch of its opposite. Changes in muscle tension manifest through this interaction of agonist and antagonist units lead to stimulation of specialized receptors within the muscle fibers (e.g., muscle spindle fibers and Golgi tendon organs) 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.

Unfortunately, the standard operative approach to upper limb amputation at either the AEA or BEA level obliterates many of the dynamic relationships characteristic of the uninjured upper extremity. Initial surgical exposure is typically accomplished through a fishmouth-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 construct in order to achieve definitive closure. The rudimentary approximation of discordant tissues in the distal limb in this approach 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 leads to impaired limb function with prostheses, but also manifests as pathological sensory perception of the extremity in the form of phantom limb and phantom pain symptoms.

To date, the limitations of these approaches have been tolerated due to the fairly simplistic goal of upper limb amputation: to provide a stable, padded surface for mounting a prosthesis. Historically, upper limb prostheses have afforded amputees the opportunity to recover at least some measure of upper limb function. However, such devices have generally not been able to recapitulate the complex biomechanics of the human upper limb due to limited ranges of motion and lack of feedback control. These limitations have resulted in reported upper limb prosthesis rejection rates ranging from 23% to 45%, including both body-powered and myoelectric devices.

However, the capabilities of modern prostheses are now expanding remarkably. Technological advances including increasingly miniaturized electronics, wireless communications and ever-refined positional sensors have enabled prosthetic developers to create next-generation bionic limbs with greatly enhanced degrees of freedom over prior models. Even more advanced prostheses are currently being developed that have the potential to offer sensory feedback - both tactile and positional - in a manner never before seen. Such prosthetic devices, while not yet available commercially, are presently being studied in experimental settings. For example, the Defense Advanced Research Projects Agency (DARPA) recently issued a request for proposals under the Hand, Proprioception and Touch Interfaces (HAPTIX) Program incorporating an upper limb prosthesis including six degrees of freedom at the wrist, thumb and all digits, 10 pressure sensors capable of providing sensory feedback, and joint angle and velocity sensors capable of providing joint position data.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Intervention group

Experimental

Modified amputation procedure

干预措施: Modified amputation procedure (Procedure)

Control group

Active Comparator

Standard amputation procedure

干预措施: Standard amputation procedure (Procedure)

结局指标

主要结局

Proprioception Recovery

时间窗: 0-36 months

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)

Motor Unit Innervation

时间窗: 0-36 months

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

Motor Unit Excursion

时间窗: 0-36 months

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

次要结局

  • Delayed Wound Healing Rate(0-36 months)
  • Deep Vein Thrombosis Rate(0-36 months)
  • Operative Revision Rate(0-36 months)
  • 30-Day Mortality Rate(0-36 months)
  • Sensory Recovery(0-36 Months)
  • Infection Rate(0-36 months)
  • Seroma Rate(0-36 months)
  • Muscle Atrophy(0-36 Months)
  • General Health Status(0-36 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Carty

Director, Lower Extremity Transplant Program

Brigham and Women's Hospital

研究点 (8)

Loading locations...

相似试验