Amputation NeuromaNCT03957226

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

A study testing e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees) in people with Amputation Neuroma and Amputation, run by University of Michigan at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 22 to 65 years
Conditions the study is for: Amputation Neuroma, Amputation, Prosthesis User
What is being tested?: e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 30 Jan 2020to 23 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Conditions: Amputation Neuroma, Amputation, Prosthesis User
Being tested: e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03957226
Study group	Role	What they receive
Trasnhumeral e-OPRA Implant	Experimental	This arm includes patients with transhumeral amputation that will receive the e-OPRA implant system. Receives: Device: e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline
Adverse Events
Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 Months Post-Op

Secondary outcomes (10)

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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 202023 Jun 2022

First posted21 May 2019
Study start30 Jan 2020 (estimated)
Primary completion23 Jun 2022
Study completion23 Jun 2022

Why it stopped: Study was not sufficiently funded. No enrollment took place.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Amputation NeuromaStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03957226
Sponsor's protocol ID: HUM00146699
Status last verified: Oct 2024
First submitted: 2 May 2019
Last updated: 4 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
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Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
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Results of Nerve Surgery to Treat PostAmputation Pain
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Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap
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All Amputation Neuroma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations
ClinicalTrials.gov ID: NCT03957226
Acronym / sponsor ID: HUM00146699
Conditions: Amputation Neuroma, Amputation, Prosthesis User
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study was not sufficiently funded. No enrollment took place.
Enrolment: 0 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: University of California, San Francisco
Study start: 30 Jan 2020 (estimated)
Primary completion: 23 Jun 2022 (actual)
Study completion: 23 Jun 2022 (actual)
First posted: 21 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Trasnhumeral e-OPRA Implant	Experimental	Device: e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees)This arm includes patients with transhumeral amputation that will receive the e-OPRA implant system.

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Male or female age 22-65 at the time of surgery.
The patient must have one of the following medical conditions:
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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Trasnhumeral e-OPRA Implant

Primary outcome

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

10 secondary outcomes

Number of Subjects with 2 or more Degrees of Freedom
Time frame: Baseline, 24 months
Change in Pain Level as measured by SF-36
Time frame: Baseline, 24 months
Change in Pain Level as measured by LANSS surveys
Time frame: Baseline, 24 months
Change in prosthetic functionality and performance as measured by the SHAP (Southhampton Hand Assessment Procedure)
Time frame: Baseline, 24 months
Change in prosthetic functionality and performance as measured by the AM-ULA (Activities Measure for Upper Limb Amputees)
Time frame: Baseline, 24 months
Change in prosthetic functionality and performance as measured by the UEFT (Upper Extremity Function Test)
Time frame: Baseline, 24 months
Change in Pain Level as measured by PROMIS (Patient Reported Outcomes Measurement Information System) Questionnaire
Time frame: Baseline, 24 months
Change in prosthetic functionality as measured by the DASH Questionnaire
Time frame: Baseline, 24 months
Change in Pain Level as measured by DVPRS (Defense and Veterans Pain Rating Scale)
Time frame: Baseline, 24 months
Change in Quality of Life as measured by the EQ-5D-5L Questionnaire
Time frame: Baseline, 24 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.

Related trials for Amputation Neuroma

Recruiting
Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
Amputation Neuroma, Amputation
Active, not recruiting
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
Symptomatic Neuroma, Amputation
RecruitingObservational study
Results of Nerve Surgery to Treat PostAmputation Pain
Amputation Neuroma
RecruitingPhase 2
Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap
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Not yet recruiting
Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Cederna, MD principal investigator

University of Michigan, Section of Plastic Surgery

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Electrical signal quality between implanted electrodes and test prosthesis (time frame: Baseline, 24 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03957226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.