Recruiting

Bone-Anchored Prostheses

Sponsor:

University of Alberta

Code:

NCT06853938

Conditions

Transhumeral Amputation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Myoelectric prosthesis

Study Details

Brief summary:

Upper limb amputation above the elbow results in a significant loss of function. There have been many advancements in surgery and prosthetic devices to restore arm function, but many people still reject upper limb prostheses. This is due to difficulties with how the socket fits and poor control of the device. Above-elbow prostheses are particularly challenging to use for several reasons. The socket must go all the way into the shoulder for stability. To hold the prosthesis onto the remaining arm, there needs to be a strap across the chest and shoulder. The prosthesis can be heavy, and the socket can slip or move around. This makes it hard to use muscle signals in the residual limb to control advanced prosthetic devices. People with limb loss are interested in advanced prostheses to use them reliably for day-to-day activities.

Bone-anchored prostheses (BAPs) are a new approach. They are for people with upper limb loss who can't use socket prostheses. The surgery involves putting a titanium rod into the remaining bone, which, over time, joins with the bone. This implant extends through the skin. It enables the direct attachment of the prosthetic parts (like the elbow and hand). With BAPs, there is no need for a socket. Also, there is a well-known surgery called "Targeted muscle reinnervation" (TMR). It improves the number of arm muscle control signals. These signals are used to control myoelectric prostheses. However, after both these surgeries, there is a lack of research that shows how best to train the muscle signals to use an advanced myoelectric arm and little evidence on what factors actually improve in a person's day-to-day life when using such a prosthesis.

This study aims to implement an enhanced muscle training protocol and fitting with a myoelectric (muscle signal-controlled) device after receiving OI and TMR for above-elbow amputation, and to evaluate the outcomes over time. The goal is to understand whether these advanced prostheses improve prosthesis use and function in daily life.

Conditions

Transhumeral Amputation

Study ID

NCT06853938

Start date

Sep 1, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

Individuals with transhumeral amputation who:

1. are between 18 and 65 years old,
2. have been scheduled to undergo osseointegration by the Alberta Limb Osseointegration Program.
3. demonstrate adequate pain-free shoulder range of motion to perform the required tasks and have potential muscle signals for myoelectric control to be able to undertake the muscle signal training
4. willing to undergo all of the study procedures and follow-up.

Exclusion Criteria:

Individuals who:

1. are unable to comply with treatment or follow-up processes,
2. are unable to understand English sufficiently to provide full informed consent.
3. have shoulder pathology on the side of the amputation (arthritis, adhesive capsulitis, chronic rotator cuff, or musculoskeletal dysfunction) that would negatively affect the ability to perform the training and functional assessments,
4. have insufficient muscle signals to operate a myoelectric prosthesis

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study group

Persons with transhumeral amputation who receive an enhanced muscle training protocol and fitting with a myoelectric (muscle signal-controlled) device after receiving osseointegrated implant and targeted muscle reinnervation.

Interventions

Myoelectric prosthesis

The interventions in this study are (1) an enhanced muscle training protocol and (2) fitting with a myoelectric (muscle signal-controlled) prosthetic device after receiving an osseointegrated implant and targeted muscle reinnervation.

Primary outcome measure

  • Prosthesis-related activity [ Time Frame: From enrollment to the end of treatment at 12 months ]

Central Contacts and Locations

Central contacts

Jacqueline S Hebert, MD, FRCPC

780-492-7846jhebert@ualberta.ca

Locations

Glenrose Rehabilitation Hospital

Recruiting

Edmonton, Alberta, Canada, T5G 0B7

Contacts

Jacqueline S Hebert, MD, FRCPC

780-492-7846jhebert@ualberta.ca

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G2R3

Contacts

Jacqueline S Hebert, MD, FRCPC

780-492-7846jhebert@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-11-18.