An interventional study of e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees) in Amputation Neuroma, Amputation and Prosthesis User, sponsored by University of Michigan. Withdrawn at 1 site in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by University of Michigan · Not applicable, Interventional, and Device feasibility
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.
70 studies on the registry are indexed under Neuroma; 11 are open to participants now.
Browse Neuroma studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
The patient must have one of the following medical conditions:
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: Baseline
Adverse Events
Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 Months Post-Op
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 24 months
This study is withdrawn, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Michigan