Pro APP Prosthetic Outcome Registry

Ö

Össur

Status

Enrolling

Conditions

Amputation

Study type

Observational

Funder types

Industry

Identifiers

NCT06210620
CIP2023092221

Details and patient eligibility

About

A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.

Full description

This US national patient and outcome registry will provide demographic information on lower-limb prosthesis users and their real-world clinical outcomes. The intent is to collect data from multiple certified O&P clinics that have access to use the digital data collection tool PRO App (https://www.ossur.com/en-us/professionals/PRO App). Any patient undergoing prosthetic treatment with their prescribed devices (such as a new fitting, alignment, or replacement of a previous prosthesis) at the investigational sites will be offered to provide data to the registry. Data collection will be a part of the standard of care and is entered by the participating prosthetists, physicians, physical therapists, or other designated staff during clinic/service visits. Data already entered into the PRO App system may also be collected into the registry if the participant consents. This registry will recruit patients who meet the inclusion criteria. Participation is fully voluntary. After the enrollment, all participants would be evaluated during follow-up visits as demanded by their standard of care. Exploratory analyses may be implemented, utilizing the already collected data, to investigate specific populations and their outcomes depending on the enrollment of said population groups. As an example; data will be collected from the registry to stratify two demographically matching groups of prosthetic users using a powered knee and a non-powered knee.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cognitive ability to understand all instructions and questionnaires in the study Willing and able to participate in the study and follow the protocol Individuals with lower limb loss, amputation or deficiency

Exclusion criteria

None

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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