Amputation Clinical Trial
Official title:
An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03947450 -
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
|
Phase 2 | |
| Completed |
NCT04924036 -
Qbrexza Cloths for Hyperhidrosis of Amputation Sites
|
Phase 2 | |
| Recruiting |
NCT04839497 -
Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.
|
Phase 2 | |
| Recruiting |
NCT04212299 -
Transfemoral Socket Design and Muscle Function
|
N/A | |
| Completed |
NCT03733054 -
Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
|
||
| Completed |
NCT03651830 -
A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations
|
N/A | |
| Not yet recruiting |
NCT06007885 -
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.
|
N/A | |
| Not yet recruiting |
NCT04936789 -
Clinical Feasibility of the IMES Transradial Prosthesis
|
N/A | |
| Completed |
NCT01155024 -
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
|
Phase 2 | |
| Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A | |
| Terminated |
NCT00778856 -
Hand Transplantation for the Reconstruction of Below the Elbow Amputations
|
N/A | |
| Recruiting |
NCT00388752 -
Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation
|
Phase 1 | |
| Active, not recruiting |
NCT03374319 -
Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations
|
N/A | |
| Completed |
NCT05542901 -
Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees
|
N/A | |
| Completed |
NCT05161364 -
Kinetic Analysis Due to Foot Dysfunction
|
||
| Recruiting |
NCT06194838 -
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
|
N/A | |
| Completed |
NCT03570788 -
HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
|
||
| Completed |
NCT05778799 -
Physical Activity and Sports for People With Special Needs
|
||
| Recruiting |
NCT04804150 -
Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System
|
N/A | |
| Terminated |
NCT03259386 -
Movement and Sensation for Advanced Prosthetic Hands
|