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

Primary Purpose

Amputation Neuroma, Amputation, Prosthesis User

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Amputation Neuroma

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trasnhumeral e-OPRA Implant

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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.
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.
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.
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.
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).
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.
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.

Full Information

First Posted
May 2, 2019
Last Updated
June 23, 2022
Sponsor
University of Michigan
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03957226
Brief Title
An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations
Official Title
An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not sufficiently funded. No enrollment took place.
Study Start Date
January 30, 2020 (Anticipated)
Primary Completion Date
June 23, 2022 (Actual)
Study Completion Date
June 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation Neuroma, Amputation, Prosthesis User

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trasnhumeral e-OPRA Implant
Arm Type
Experimental
Arm Description
This arm includes patients with transhumeral amputation that will receive the e-OPRA implant system.
Intervention Type
Device
Intervention Name(s)
e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Electrical signal quality between implanted electrodes and test prosthesis
Description
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
Title
Adverse Events
Description
Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.
Time Frame
Baseline
Title
Adverse Events
Description
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
Title
Adverse Events
Description
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
Title
Adverse Events
Description
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
Title
Adverse Events
Description
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
Title
Adverse Events
Description
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
Title
Adverse Events
Description
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
Title
Adverse Events
Description
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
Title
Adverse Events
Description
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
Secondary Outcome Measure Information:
Title
Number of Subjects with 2 or more Degrees of Freedom
Description
The number of subjects achieving 2 or more degrees of freedom summarized using frequency and percentage
Time Frame
Baseline, 24 months
Title
Change in Pain Level as measured by SF-36
Description
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
Title
Change in Pain Level as measured by LANSS surveys
Description
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
Title
Change in prosthetic functionality and performance as measured by the SHAP (Southhampton Hand Assessment Procedure)
Description
Measured by the participant performing the SHAP at each experimental visit. A higher score indicates increased upper limb functionality.
Time Frame
Baseline, 24 months
Title
Change in prosthetic functionality and performance as measured by the AM-ULA (Activities Measure for Upper Limb Amputees)
Description
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
Title
Change in prosthetic functionality and performance as measured by the UEFT (Upper Extremity Function Test)
Description
Measured by the participant performing the UEFT at each experimental visit. A higher score indicates increased upper limb functionality.
Time Frame
Baseline, 24 months
Title
Change in Pain Level as measured by PROMIS (Patient Reported Outcomes Measurement Information System) Questionnaire
Description
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
Title
Change in prosthetic functionality as measured by the DASH Questionnaire
Description
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
Title
Change in Pain Level as measured by DVPRS (Defense and Veterans Pain Rating Scale)
Description
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
Title
Change in Quality of Life as measured by the EQ-5D-5L Questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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