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

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.

Study Overview

• Status: Withdrawn
• Conditions: Amputation; Prosthesis User; Amputation Neuroma
• Intervention / Treatment: Device: e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female age 22-65 at the time of surgery.

• The patient must have one of the following medical conditions:

  • A condition requiring performance of a unilateral transhumeral amputation;
  • An existing transhumeral OPRA device implanted under IDE G150155;
  • An existing unilateral transhumeral amputation; or
  • An existing unilateral transhumeral amputation with previous nerve reinnervation surgery.
• The patient must have a residual humerus of greater than or equal to 10 cm.
• The patient must have a cortical thickness of at least 1.5 mm.
• The patient must have at least a portion of biceps and triceps muscles present.
• The subject must have undergone consultation with at least two upper extremity surgical specialists to ensure they have exhausted all limb salvage options prior to undergoing amputation.
• The patient must have adequate bone stock to support the implanted device.
• In the opinion of the Investigators, normal cognitive function and absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude patient from being a good surgical and/or study candidate.
• Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program.
• Written informed consent to participate in the study provided by the patient or legal representative.

Exclusion Criteria:

• Women who are pregnant, lactating, or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up.
• Arthrosis of the ipsilateral glenohumeral joint by radiographs.
• Subjects who have not been completely abstinent from tobacco use for at least 6 weeks preoperatively.
• Active or dormant infection.
• Evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, neuropathy, neuropathic disease, severe phantom pain, or osteoporosis, such that, in the opinion of the Investigator, the subject will not be a good study candidate.
• History of systemically administered corticosteroids, immunosuppressive therapy, or chemotherapeutic drugs within six (6) months of implant surgery.
• Severe medical co-morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, other indwelling electronic implants, mental incapacity, substance abuse, shortened life expectancy, and vulnerable patient population).
• Current involvement in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Trasnhumeral e-OPRA Implant; This arm includes patients with transhumeral amputation that will receive the e-OPRA implant system.

Device: e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Electrical signal quality between implanted electrodes and test prosthesis	Efficacy will be evaluated by signal-to-noise ratio during maximum voluntary contraction of at least two independent myoelectric signals.	Baseline, 24 months
Adverse Events	Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.	Baseline
Adverse Events	Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.	3 Months Post-Op
Adverse Events	Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.	6 Months Post-Op
Adverse Events	Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.	9 Months Post-Op
Adverse Events	Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.	12 Months Post-Op
Adverse Events	Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.	15 Months Post-Op
Adverse Events	Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.	18 Months Post-Op
Adverse Events	Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.	21 Months Post-Op
Adverse Events	Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.	24 Months Post-Op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects with 2 or more Degrees of Freedom	The number of subjects achieving 2 or more degrees of freedom summarized using frequency and percentage	Baseline, 24 months
Change in Pain Level as measured by SF-36	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.	Baseline, 24 months
Change in Pain Level as measured by LANSS surveys	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.	Baseline, 24 months
Change in prosthetic functionality and performance as measured by the SHAP (Southhampton Hand Assessment Procedure)	Measured by the participant performing the SHAP at each experimental visit. A higher score indicates increased upper limb functionality.	Baseline, 24 months
Change in prosthetic functionality and performance as measured by the AM-ULA (Activities Measure for Upper Limb Amputees)	Measured by the participant performing the AM-ULA at each experimental visit. A higher score indicates increased upper limb functionality.	Baseline, 24 months
Change in prosthetic functionality and performance as measured by the UEFT (Upper Extremity Function Test)	Measured by the participant performing the UEFT at each experimental visit. A higher score indicates increased upper limb functionality.	Baseline, 24 months
Change in Pain Level as measured by PROMIS (Patient Reported Outcomes Measurement Information System) Questionnaire	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.	Baseline, 24 months
Change in prosthetic functionality as measured by the DASH Questionnaire	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).	Baseline, 24 months
Change in Pain Level as measured by DVPRS (Defense and Veterans Pain Rating Scale)	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.	Baseline, 24 months
Change in Quality of Life as measured by the EQ-5D-5L Questionnaire	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.	Baseline, 24 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Paul Cederna, MD, University of Michigan, Section of Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2020
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 18, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nerve Sheath Neoplasms; Neuroma
• Other Study ID Numbers: HUM00146699

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes