Optimizing Transhumeral Osseointegration Prosthesis Control

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.

Study Overview

• Status: Recruiting
• Conditions: Transhumeral Amputation
• Intervention / Treatment: Device: Myoelectric prosthesis

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacqueline S Hebert, MD, FRCPC; Phone Number: 780-492-7846; Email: jhebert@ualberta.ca
• Study Contact Backup: Name: Mayank Rehani, MSc; Phone Number: 780-492-4736; Email: rehani@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5G 0B7
      • Recruiting
      • Glenrose Rehabilitation Hospital
      • Contact: Jacqueline S Hebert, MD, FRCPC; Phone Number: 780-492-7846; Email: jhebert@ualberta.ca
      • Contact: Mayank Rehani, MSc; Phone Number: 780-492-4736; Email: rehani@ualberta.ca
    • Edmonton, Alberta, Canada, T6G2R3
      • Recruiting
      • University of Alberta
      • Contact: Jacqueline S Hebert, MD, FRCPC; Phone Number: 780-492-7846; Email: jhebert@ualberta.ca
      • Contact: Mayank Rehani, MSc; Phone Number: 780-492-4736; Email: rehani@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthesis-related activity	The percentage reliance on the use of the prosthesis compared to the dominant arm. Prosthesis-related activity will be measured by participants wearing activity sensor bracelets (commercially available accelerometer-based sensors, i.e. Actigraph), one on each arm, for 7 days at each assessment time point. We will calculate the sum of seconds of active use for each arm to calculate the ratio of symmetry. The primary measure will be the percentage reliance on the dominant side, calculated for when the prosthesis is worn. Measures of unilateral and bilateral activities will also be computed.	From enrollment to the end of treatment at 12 months

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): June 14, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: Pro00140248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No