Clinical Feasibility of the IMES Transradial Prosthesis

Össur

Status: Not yet enrolling

Conditions: Amputation

Treatments: Device: IMES

Study type: Interventional

Funder types: Industry

Identifiers

NCT04936789

CIP2020072116

Details and patient eligibility

About

This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis

Full description

The study assesses the feasibility of an implantable myoelectric prosthesis control system to control a transradial prosthesis. Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles of three transradial amputee subjects. These devices wirelessly transmit electrical muscle signals to an electromechanical prosthetic wrist and hand.

Following a two-week recovery from implantation of up to 16 IMES into residual forearm muscles, subjects will begin a two week training phase. When they receive their custom-fit IMES Transradial Prosthesis (including electromechanical wrist and hand) subjects initiate approximately four months of home use. Subjects will be offered up to five post-study follow-up visits. The usability and functionality of the prosthetic system will be evaluated throughout the study.

Enrollment: 3 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (unilateral acquired transradial) amputation
• residual limb size requirements to fit investigational device componentry
• at least 6 residual muscle locations available for implantation
• good compliance with health service (rehabilitation)
• willing to undergo surgical implantation of IMES Sensor implants
• experience with myoelectric upper limb prostheses
• using own myoelectric device approximately 6-8h/day
• able to provide informed consent and attend the study visits

Exclusion criteria

• any condition which in the opinion of the investigator poses a risk to health
• neurological disorder that may prohibit accurate control
• major injury proximal to the level of amputation
• neuromuscular disorder
• nerve transection or palsy that may cause de-innervation of muscles planned for implantation
• allergy to implanted materials
• existing active implant

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Single arm

Experimental group

Description:

Single arm. All subjects will receive the intervention. Comparator device will be subjects' own prosthesis at baseline.

Treatment:

Device: IMES