Clinical Feasibility of the IMES Transradial Prosthesis

NCT ID: NCT04936789

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-01-31

Brief Summary

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

Detailed 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.

Conditions

Amputation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Single arm

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

Group Type: EXPERIMENTAL

IMES

Intervention Type: DEVICE

Surgical implantation of IMES

Interventions

IMES

Surgical implantation of IMES

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Össur Iceland ehf

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aidan Roche, MD

Role: PRINCIPAL_INVESTIGATOR

NHS; University of Edinburgh

Locations

NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Daire McGuinness, BSc

Role: CONTACT

dmcguinness@ossur.com

00441315070097

Facility Contacts

Aidan Roche

Role: primary

Other Identifiers

CIP2020072116

Identifier Type: -

Identifier Source: org_study_id