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

NCT03957226 | Withdrawn DMC FDA Device

• 1 other identifier: HUM00146699
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation Neuroma; Amputation; Prosthesis User

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (10)

• Number of Subjects with 2 or more Degrees of Freedom

  Baseline, 24 months

• Change in Pain Level as measured by SF-36

  Baseline, 24 months

• Change in Pain Level as measured by LANSS surveys

  Baseline, 24 months

• Change in prosthetic functionality and performance as measured by the SHAP (Southhampton Hand Assessment Procedure)

  Baseline, 24 months

• Change in prosthetic functionality and performance as measured by the AM-ULA (Activities Measure for Upper Limb Amputees)

  Baseline, 24 months

Study Arms (1)

Trasnhumeral e-OPRA Implant

EXPERIMENTAL

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)

Interventions

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.

Trasnhumeral e-OPRA Implant

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Paul Cederna, MD

  University of Michigan, Section of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Robert Oneal Professor of Plastic Surgery, Chief of the Section of Plastic Surgery

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 21, 2019
• Study Start: January 30, 2020
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

US (1)