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MyLeg System: The functional evaluation of a powered knee-ankle prosthesis prototype for osseointegrated transfemural amputees

MyLeg System: The functional evaluation of a powered knee-ankle prosthesis prototype for osseointegrated transfemural amputees - MyLeg System

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52253
Enrollment
1
Registered
2022-08-30
Start date
2022-11-29
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Above-knee amputation transfemoral amputation

Interventions

An introduction and practice with the MyLeg System inside the Radboudumc under supervision of a physiotherapist, researcher, orthopaedic technician, and the manufacturer.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 year or older and able to provide informed consent. Underwent a uni-lateral transfemoral amputation and underwent a surgery implementing the osseointegration implant more than 2 years ago. Able to walk independently (MFC-level K3 or higher)

Exclusion criteria

Exclusion criteria: Vascular, neurological or musculoskeletal conditions or medication affecting balance or gait Patients with psychiatric disorders Weight > 100 kg Current problems with the alignment of the prosthesis Fitted with a new prosthesis knee-component within the last 3 months or with a new prosthesis ankle-component within the last month

Design outcomes

Primary

MeasureTime frame
The main study parameters are subjective evaluation of the functionality of the prosthesis and the participant*s experience are evaluated by the answers on the user report.

Secondary

MeasureTime frame
In addition, heart rate, and the symmetry index for spatiotemporal, kinetic and kinematic parameters will be evaluated.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)