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This arm includes patients with transhumeral amputation that will receive the e-OPRA implant system.

The e-OPRA is an implant system that provides an alternative to traditional socket prostheses by establishing a direct, load-bearing link between the patient's skeleton and a prosthesis for transhumeral amputees. The anchorage element of the system is implanted directly into the bone while the electrodes that provide control signals for the prosthesis are implanted into muscle grafts on the transhumeral amputation.

e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees)

This early feasibility study proposes to evaluate use of the electronic-Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) device, a transhumeral implant system for direct skeletal anchorage of amputation prostheses, with a test prosthesis. The e-OPRA System is being investigated to better understand the ability to improve the functionality of the prosthesis and enhance the sense of embodiment of the prosthesis itself. This will be a 10 subject Early Feasibility Study in which the primary objective is to capture preliminary safety and effectiveness information on the implanted e-OPRA system. With the addition of electrodes to the muscle segments, this biological interface allows for both the extraction of fine motor control signals from the nerve fascicles and the generation of sensory percepts via electrical stimulation of the muscles. In addition, electrodes placed on muscles within the residuum with native vascularization and innervation also allow the extraction of critical motor control signals and the generation of sensory feedback through muscle stimulation. The electrical activity recorded from these muscle segments (called electromyography or EMG) is specific to certain movements and can be used to determine precisely how a person wants to move their arm and hand. Use of the e-OPRA device with the well-documented neuro-electronic capabilities of EMG control systems provides an alternative to traditional socket prostheses by establishing a direct, loadbearing link between the patient's skeleton and prosthesis.

An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations

Efficacy will be evaluated by signal-to-noise ratio during maximum voluntary contraction of at least two independent myoelectric signals.

Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.

The number of subjects achieving 2 or more degrees of freedom summarized using frequency and percentage

Change in Pain Level as measured by SF-36 survey Pain will be assessed using the SF-36 survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability.

Change in Pain Level as measured by LANSS survey Pain will be assessed using the LANSS survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. A score greater than 12 (From 0 to 15) indicates neuropathic pain.

Measured by the participant performing the SHAP at each experimental visit. A higher score indicates increased upper limb functionality.

Measured by the participant performing the AM-ULA at each experimental visit. A higher score indicates increased upper limb functionality.

Measured by the participant performing the UEFT at each experimental visit. A higher score indicates increased upper limb functionality.

Change in Pain Level as measured by LANSS survey Pain will be assessed using the LANSS survey instrument, to be filled out by the participant before surgery and at each experimental visit. The Numeric Rating Scale measures (adult, pediatric, parent proxy) each consist of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain you can think of). The items are not calibrated and do not produce a T-score. Instead, raw response scores (0 to 10) should be used for analyses.

Measured by the participant filling out the DASH questionnaire before surgery and at each experimental visit every 3 months. A score closer to 1 indicates higher functionality. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). The raw is transformed to a zero-to-100 scale, with an average score closer to 100 meaning higher disability (unable to perform tasks).

Measured by the participant assigning a number 1-10 of their pain while viewing the DVPRS. A score close to of 0 indicates zero pain, and a score of 10 indicates maximum pain as bad is it can be.

Measured by the participant filling out the EQ-5D-5L before surgery and at each experimental visit every 3 months. Each question is scored from 1-5, with 5 having the most difficulty in that area.

University of California, San Francisco

University of Michigan

Robert Oneal Professor of Plastic Surgery, Chief of the Section of Plastic Surgery

Symptoms and General Pathology

Prosthesis Failure

Pain

Postoperative Complications

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

All subjects enrolled in this study will undergo pre-operative evaluation, anesthesia, and dissection to identify the painful residual limb neuroma(s). Gentle traction will be applied to the nerve while excising the neuroma (traction neurectomy) allowing the nerve to retract more proximally.Targeted muscle reinnervation involves transfer of residual nerves to otherwise redundant target muscles. Native motor innervation of the target muscle is cut, and the residual nerves-after excision of end-neuromas-are coapted to the motor end point of the motor nerve, close to its point of entry into the muscle.

Targeted reinnervation (TR) is a surgical procedure originally designed to provide intuitive control of upper limb prostheses through transfers of residual nerves to otherwise redundant target muscle. Native motor innervation of the target muscle is cut, and the residual nerves-after excision of end-neuromas-are coapted to the motor end point of the motor nerve, close to its point of entry into the muscle. The central principle underlying the nerve transfers in TR surgery is to reestablish the function of the amputated nerve and allow intuitive, seamless prosthesis control.

Targeted Muscle Reinnervation

Subjects are being asked to participate in this study because they have an arm or leg amputation and have developed pain related to a neuroma (an ongoing localized pain related to a cut nerve ending).

The investigators are studying how targeted reinnervation (TR) helps to both treat neuroma pain and to have increased prosthetic control. This surgery connects these cut nerve endings to nerves going into nearby nonfunctional muscles. This surgery was developed to allow amputees to have better prosthesis control. By chance, neuroma pain improved significantly with TR. The investigators, therefore, are conducting this clinical trial. The investigators will ask all participants to fill out a questionnaire both before and after surgery. This will help us understand how a neuroma affects the quality of life of amputee will allow us to understand how to best improve neuroma pain and prosthesis control.

In order to confirm the presence and location of the neuroma before surgery, a magnetic resonance image (MRI) will be performed. Taking these pictures requires subjects to lie still for a short period of time but does not involve any invasive procedures.

Loss of an arm or leg is a significant injury that affects a person's job prospects, personal relationships, and overall quality of life. Approximately 25% of all amputees will develop chronic local pain in the remaining part of their amputated limb. This pain is caused by neuromas- disorganized nerve endings and scar tissue that form when an injured nerve tries to heal. Every cut nerve will develop a neuroma unless the two ends of the nerve can be rejoined. With limb amputation, the nerves are cut and one end is lost with the limb, preventing the nerve from repairing itself. Instead, the cut nerve ending forms a painful neuroma. Chronic pain from neuromas is a major reason that amputees cannot wear or use their prostheses comfortably and increases their disability.

Even when a limb is amputated, the nerves that used to control that limb still carry messages from the brain. Those messages are intended to tell the muscles how or when to move the missing limb, but after amputation, these limb-control nerves are no longer connected to muscles. In 2002, researchers at Northwestern Memorial Hospital in conjunction with the Rehabilitation Institute of Chicago developed a new type of surgery called targeted muscle reinnervation (TMR). In TMR, limb-control nerves are transferred so that they can control new target muscles. The neuromas from the limb-control nerves are removed, then the small nerve that controls the target muscle is cut. The two nerves are joined together so that the limb-control nerve can then grow into, or reinnervate the target muscle. After TMR, when the person tries to move the missing limb, the target muscle contracts instead and these signals can be detected and used to control a prosthesis. TMR has now been done successfully almost 100 times worldwide. Interestingly, almost all of the patients who had painful neuromas before TMR had no neuroma pain after surgery. This result was investigated in laboratory studies - both rat and rabbit amputee neuromas were "cured" with TMR. We think that giving the cut nerve endings somewhere to go and something to do prevents a neuroma from forming.

We will measure the effectiveness of both surgeries using an internet-based amputee pain questionnaire. We expect that TMR will be more effective for neuroma pain and prosthesis control than the standard treatment. This will change how patients with neuroma pain are treated and help thousands of patients with amputations.

Targeted Reinnervation for Neuromas as a Means to Improve Prosthesis Control in Major Limb Amputation

Compare patient-reported pre-operative survey results to those after surgical intervention at intervals over time (1 month, 3 months,6 months, 9 months,1 year, and then every six months thereafter until the conclusion of the study).

Using the same PROMIS platform, general health, physical functioning (including functional prosthesis wear), and satisfaction following surgery will also be assessed as important secondary outcomes, resulting in a more comprehensive and objective understanding of the effects of the two surgical approaches on neuroma pain.

Another particularly useful tool for this study is the Orthotics and Prosthetics User Survey (OPUS) Functional Status. The OPUS is a validated instrument that assesses how well patients are using their prostheses. Thus, we will examine a very important secondary measure of neuroma pain-the ability to use a prosthesis. Prosthesis use is often the primary problem for individuals with painful neuromas; they hurt most during walking with a prosthesis or when wearing a prosthetic arm.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations	NCT03957226	Amputation Neur... Amputation Prosthesis User	e-OPRA (electro...	22 Years - 65 Years	University of Michigan
Targeted Reinnervation for Neuromas as a Means to Improve Prosthesis Control in Major Limb Amputation	NCT02316262	Neuroma Pain Prosthesis User Prosthesis Fail...	Targeted Muscle...	18 Years - 85 Years	Northwestern University
Targeted Reinnervation for Neuromas as a Means to Improve Prosthesis Control in Major Limb Amputation	NCT02316262	Neuroma Pain Prosthesis User Prosthesis Fail...	Targeted Muscle...	18 Years - 85 Years	Northwestern University

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