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Recruiting

NCT Number: NCT06210620

Pro APP Prosthetic Outcome Registry

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Provide data on patient characteristics

    Time frame: 10 years

    The primary objective of this study is to generate a national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.

Secondary outcomes

  1. Provide data on device performance

    Time frame: 10 years

    To perform comparative analysis on the population and subgroups based on demographics, device brands, device types, device technology, patient reported outcomes, observer-reporter, and objective clinical assessments

Sponsors and collaborators

Lead sponsor

Össur Iceland ehf

Industry

Registry information

Official study title

Prospective, Observational Registry to Collect Standard of Care Clinical Testing Data From Lower-limb Prosthesis Patients Via the PRO App.

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Jan 18, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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