Pro APP Prosthetic Outcome Registry

Last updated: January 8, 2024
Sponsor: Össur Ehf
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06210620
CIP2023092221
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: Cognitive ability to understand all instructions and questionnaires in the study Willingand able to participate in the study and follow the protocol Individuals with lower limbloss, amputation or deficiency

Exclusion

Exclusion Criteria: None

Study Design

Total Participants: 2000
Study Start date:
January 01, 2024
Estimated Completion Date:
September 30, 2033

Study 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.

Connect with a study center

  • Össur Americas

    Irvine, California 92610
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.